Sanofi
ENXTPA:SAN
€
84,57
€
-1,07 € (-1,25 %)
84,57
€
-1,07 € (-1,25 %)
Schlusskurs: 04.12.2025
Sanofi Aktie Bewertung
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Sanofi Datenblatt
Gewinn-Wachstumsrate 5 J.
3,52 %
Börsenwert
102,91 Mrd. €
Langfristige Schulden
11,79 Mrd. €
Jahresabschluss
29.01.2026
Dividende
3,87 €
Dividendenrendite
4,58 %
Gegründet
1994
Industrie
Land
Webseite
ISIN-Nummer
Webseite
Kursziel der Analysten
105,00 €
24.16%
Letztes Update: 05.12.2025
Analysten: 22
Höchstes Kursziel 124,80 €
Durchschnittliches Kursziel 105,00 €
Niedrigstes Kursziel 95,00 €
In den letzten fünf Quartalen ist das Kursziel für Sanofi von 118,53 € auf 116,62 € gefallen - ein Rückgang von -1,61 %. Die Achtzehn Analysten sagen voraus, dass der Aktienkurs von Sanofi im kommenden Jahr steigen und 105,00 € erreichen wird. Das entspräche einer Steigerung von 24,16 %.
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Was macht Sanofi?
Sanofi is a global healthcare company, focused on patient needs and engaged in the research, development, manufacture and marketing of therapeutic solutions.
The Biopharma operating segment comprises commercial operations and research, development and production activities relating to the Specialty Care, General Medicines and Vaccines franchises plus support and corporate functions, for all geographical territories. It also includes revenues generated by legal entities within the Biopharma segm...
Sanofi is a global healthcare company, focused on patient needs and engaged in the research, development, manufacture and marketing of therapeutic solutions.
The Biopharma operating segment comprises commercial operations and research, development and production activities relating to the Specialty Care, General Medicines and Vaccines franchises plus support and corporate functions, for all geographical territories. It also includes revenues generated by legal entities within the Biopharma segment (and included in the scope of continuing operations) from the manufacture of Consumer Healthcare products on behalf of legal entities within Opella; those revenues are presented within Other Revenues in the income statement. The Biopharma operating segment also includes the purchase price of Biopharma products manufactured by legal entities within the Opella scope.
The ‘Other’ category comprises primarily, but not exclusively, Consumer Healthcare activities that will not be transferred on the effective date of loss of control of Opella. These are primarily (i) hospital sales of Opella products in China, the transfer of which will be finalized no earlier than 2028 after a transitional period required to complete the transfer plan agreed with Sanofi in the context of public tendering arrangements ; (ii) sales made by the dedicated entity Opella Russie, the equity interests in which will be retained by Sanofi. Sanofi will continue to distribute Opella products in Russian territory under the distribution agreement signed in connection with the separation, the parties reserving the right to discuss the transfer of this retained interest during the distribution agreement term ; and (iii) sales of the Gold Bond product range, which are continuing in the United States through the retained subsidiary Gold Bond LLC (holder of the associated worldwide property rights).
On March 13, 2023, Sanofi and Provention Bio, Inc. (Provention), a U.S.-based publicly-traded biopharmaceutical company developing therapies to prevent and intercept immune-mediated diseases, including type 1 diabetes. On April 27, 2023, Sanofi announced the completion of its acquisition of Provention. The acquisition added Tzield (teplizumab-mzwv), a therapy for type 1 diabetes, to Sanofi’s core General Medicines medicine portfolio.
On July 28, 2023, Sanofi announced that it had entered into a definitive agreement to acquire ownership of Qunol, a market-leading U.S.-based health & wellness brand. This transaction was intended to strengthen Opella in the Vitamin, Mineral and Supplements (VMS) category, one of the largest and fastest-growing consumer health categories in the U.S., focused on the dynamic healthy aging segment. Sanofi’s acquisition of QRIB Intermediate Holdings, LLC was completed on September 29, 2023.
On May 30, 2024, Sanofi announced that it had completed the acquisition of Inhibrx, Inc (Inhibrx), a publicly-traded, clinical-stage biopharmaceutical company focused on developing a pipeline of novel biologic therapeutic candidates in oncology and orphan diseases. The acquisition added SAR447537 (formerly INBRX-101) to Sanofi’s rare disease development portfolio. Since the closing of the merger, Inhibrx has become a wholly owned subsidiary of Sanofi. Additionally, Sanofi retains a minority stake (approximately 8%) in New Inhibrx.
Sanofi’s activities are organized around the following categories: Immunology & Inflammation, Rare Diseases, Neurology, Oncology, Other Medicines, Vaccines, and Opella.
Strategic Framework
The Sanofi ‘Play to Win’ strategy is organized around various key priorities: focus on growth and lead with innovation.
In October 2023, the company had entered the next chapter of the company’s Play to Win Strategy and increased investments in the company’s pipeline to fully realize long-term growth potential, bolstered by successful launches and R&D progress; launched strategic cost initiatives, with most of the savings to be reallocated to fund innovation and growth drivers; and announced the company’s intention to separate the Consumer Healthcare Business.
Focus on Growth
Dupixent (dupilumab) – By leveraging the product’s unique mechanism of action targeting the type 2 inflammation pathway and its favorable safety profile, the company has raised its ambition for peak sales of Dupixent. In September 2024, Dupixent was approved in the U.S. by the FDA as the first-ever biologic medicine for patients with Chronic Obstructive Pulmonary Disease (COPD).
Vaccines – Sanofi has progressed to continued strong growth, driven by four core franchises: Influenza; Meningitis; Polio, Pertussis a Hib (PPH) & Boosters; and Respiratory syncytial virus (RSV).
Pipeline – The company is focusing its investments on projects in immunology, rare diseases, neurology and vaccines.
Lead with innovation
The company has been able to shift from a priority medicine list to a steady flow of medicines in a refocused, consistent pipeline. The company’s pipeline is showing potential opportunities for market-leading products.
To continue fueling the company’s promising pipeline and enhance the company’s position in the company’s core therapeutic areas, the company has:
Acquired Inhibrx, Inc,. adding a potential best-in-class rare disease medicine for Alpha-1 Antitrypsin Deficiency to the pipeline;
Entered into a strategic collaboration with Synthekine to develop and commercialize IL-10 receptor agonists for the treatment of inflammatory diseases;
Established a strategic collaboration with Belharra to advance the discovery of novel small molecule therapeutics for immunological diseases;
Established a co-exclusive licensing agreement with Novavax to co-commercialize a COVID-19 vaccine and develop novel flu-COVID-19 combination vaccines;
Entered into an exclusive worldwide out-licensing agreement with Vir Biotechnology for three clinical-stage masked T-cell engagers and exclusive use of the protease-cleavable masking platform for oncology and infectious diseases, medicines previously acquired by Sanofi from Amunix Pharmaceuticals;
Entered into a three-way collaboration with Formation Bio and OpenAI to build AI-powered software to accelerate drug development and bring new medicines to patients more efficiently;
Secured rights to develop a CD73 inhibitor(uliledlimab) in China, from VJ Pharma, a company spun out from I-Mab; and
Entered into an exclusive licensing agreement (i) with RadioMedix to develop radiopharmaceuticals for PET imaging and targeted alpha therapy (TAT) to respond to unmet medical needs in cancer, and (ii) with Orano Med to develop lead-212 (212Pb) radioligand therapies (RLTs) for cancer.
In 2024, in partnership with Aily Labs, the company deployed the internal application plai. Plai aggregates internal data across all functions and harnesses the power of AI to provide timely insights and personalized ‘what if’ development scenarios to support informed decision-making.
In 2024, the company had partnered with FormationBio and OpenAI to develop AI-powered software to accelerate drug development, create custom drug development lifecycle solutions and bring new medicines to patients more efficiently:
In 2024 the company focused on unifying Sanofi’s approach to data and AI, standardizing the company’s approach to unlock value through shared tools and assets;
Sanofi's internal GenAI tools are maturing rapidly, with Concierge (launched October 2024) and a successful M365 Copilot pilot completed;
Over 2,000 new users, across verticals, were trained on GenAI tooling delivered from GenAI Board-approved use cases in 2024; and
Approximately 7,000 Sanofi employees received training throughout Gen AI courses on SanofiU, the company’s in-house learning platform.
Segments
Biopharma segment
Immunology & Inflammation
Dupixent
Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. Dupilumab is jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 59 completed studies and 23 ongoing studies, involving more than 12,000 patients with various chronic diseases driven in part by type 2 inflammation. The dupilumab development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 studies, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple inflammatory diseases, such as atopic dermatitis (AD), asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis. Dupixent comes in either a pre-filled syringe for use in a clinic or at home by self-administration as a subcutaneous injection or in a pre-filled pen for at-home administration, providing patients with a more convenient option. Dupixent is available in all major markets including the U.S. (since April 2017), most European Union countries (the first launch was in Germany in December 2017), Japan (since April 2018), and China (since June 2020).
Atopic Dermatitis (AD)
In 2014, the FDA also granted Dupixent Breakthrough Therapy designation, and after a Priority Review evaluation, it granted Dupixent marketing authorization in March 2017 for the treatment of adults with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. In 2016, the FDA granted Dupixent Breakthrough Therapy designation for adolescent patients aged 12 to 17 years and in March 2019, the FDA extended the marketing authorization to cover this age group.
In 2016, the FDA granted Breakthrough Therapy designation for Dupixent for the treatment of severe AD in children aged six months to 11 years. On May 26, 2020, Dupixent was approved as the first biologic medicine for children aged six to 11 years with moderate-to-severe AD. Having accepted Dupixent for Priority Review in February 2022, the FDA approved Dupixent on June 7, 2022 for children aged six months to five years with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable, making Dupixent the first biologic medicine to significantly reduce signs and symptoms in children as young as six months.
The EC approved Dupixent in September 2017 for use in adults with moderate-to-severe AD who are candidates for systemic therapy, and extended the marketing authorization in August 2019 to include adolescents aged 12 to 17 years. On November 30, 2020, the EC extended the marketing authorization to children aged six to 11 years with severe AD and on June 28, 2021, the Dupixent label was updated with long-term data for up to three years, reinforcing the medicine’s well-established safety profile in adults with moderate-to-severe AD. On January 27, 2023 the CHMP adopted a positive opinion for Dupixent, recommending expanded approval in the EU to treat severe AD in children aged six months to five years who are candidates for systemic therapy. In March 2023, Dupixent was approved by the EC as the first and only targeted medicine for children as young as six months old with severe AD.
On January 22, 2018, the Ministry of Health, Labor and Welfare (MHLW) in Japan granted marketing and manufacturing authorization for Dupixent for the treatment of AD in adults not adequately controlled with existing therapies. More recently, on September 25, 2023 Dupixent was approved in Japan to treat patients aged six months and older with moderate-to-severe AD.
On June 19, 2020, the National Medical Products Administration (NMPA) in China approved Dupixent for adults for the treatment of moderate-to-severe AD after identifying dupilumab as an overseas medicine regarded as urgently needed in clinical practice, leading to an expedited review and approval process. On December 28, 2020, the National Healthcare Security Administration (NHSA) officially announced the results of the 2020 National Reimbursement Drug List (NRDL) negotiations, with Dupixent 300 mg included in the updated NRDL effective March 1, 2021. Dupixent was approved in China in September 2021 for adolescents aged 12-17 years with moderate-to-severe AD. The indication for children aged six years and over, along with the adolescent and adult AD indications, was included in the current NRDL reimbursement scope, which was reviewed during the Dupixent NRDL renewal in 2022 in accordance with the two-year cycle for the China access process. In May 2023, Dupixent was approved in China to treat moderate to severe AD in infants and children aged six months and older.
In April 2023, new abstract data from a long-term efficacy open-label study presented at the Revolutionizing Atopic Dermatitis (RAD) 2023 Spring Conference in Washington, DC showed that Dupixent demonstrated robust and sustained efficacy with progressive improvement of AD signs and symptoms in patients with moderate-to-severe AD who completed up to five years of treatment: the longest duration of data for any biologic medicine in this disease. Additionally, the long-term safety data from a 52-week open-label extension study in children aged six months to five years reinforced the well-established safety profile of Dupixent observed across all other approved age groups. These data build on the existing evidence supporting the selective way Dupixent inhibits IL4/IL-13 pathways, both key and central drivers of type 2 inflammation, thereby significantly improving itching and skin lesions and other important measures that impact a patient’s quality of life. The inclusion of the results from the five-year OLE study for adults in the Dupixent label was approved in Europe in June 2023, and in the U.S. by the FDA in October 2023.
In March 2023, positive results from the clinical study assessing Dupixent in adults and adolescents with uncontrolled moderate- to-severe atopic hand and foot dermatitis were presented in a late-breaking session, one of more than 20 Dupixent scientific presentations, at the American Academy of Dermatology (AAD) 2023 Annual Meeting. The study, evaluating a biologic for this difficult-to-treat population, met its primary and key secondary endpoints. In August 2023, the clinical section of the Dupixent label in Europe was updated to include the hand and foot dermatitis population. In January 2024, the Dupixent U.S. label was updated with data further supporting use in AD with moderate-to-severe hand and foot involvement.
These Phase 3 data are from the first and only study evaluating a biologic specifically for this difficult-to-treat population and have also been added to the Dupixent label in the European Union, with regulatory submissions under way in additional countries.
Asthma
Dupixent was granted marketing authorization by the FDA in October 2018 as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. In May 2019, the EC approved Dupixent for use as an add-on maintenance treatment in severe asthma patients aged 12 years and older with type 2 inflammation whose symptoms are inadequately reduced by other treatments.
In September 2020, new long-term data from a Phase 3 open-label extension study showed sustained improvement in lung function and reduction in severe exacerbations in adults and adolescents with moderate-to-severe asthma. On May 17, 2021, detailed results from a Phase 3 study showed Dupixent significantly reduced severe asthma attacks, and within two weeks rapidly improved lung function in children aged six to 11 years with uncontrolled moderate-to-severe asthma with evidence of type 2 inflammation. Moreover, Dupixent significantly improved overall asthma symptom control and reduced an airway biomarker of type 2 inflammation, called fractional exhaled nitric oxide (FeNO), that plays a major role in asthma.
In October 2021, the FDA approved Dupixent as an add-on maintenance treatment for patients aged six to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma, thereby bringing a new treatment for children who may be suffering from life-threatening asthma attacks and poor lung function affecting their ability to breathe, which could potentially continue into adulthood. On April 7, 2022, the EC approved Dupixent for use in children aged six to 11 years as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised FeNO, whose symptoms are inadequately reduced with medium to high dose inhaled corticosteroids (ICS) plus another medicine for maintenance treatment.
In March 2019, Dupixent was approved in Japan for treating patients aged 12 years and over with severe or refractory asthma whose symptoms are inadequately controlled with existing therapies. In November 2023, Dupixent received approval in China for the treatment of moderate to severe asthma patients aged 12 years and over with type 2 inflammation.
In February 2024, topline results from the VESTIGE Phase 4 clinical study were presented at the 2024 American Academy of Allergy, Asthma, and Immunology Annual Meeting. This study evaluated the effects of Dupixent on airway remodeling in adults with uncontrolled moderate-to-severe asthma characterized by an eosinophilic phenotype or those dependent on oral corticosteroids.
In 2024, Sanofi initiated a Phase 3 study for children aged 2 to 6 years suffering from asthma. This parallel, two-arm Phase 3 study aims to evaluate the efficacy and long-term safety of dupilumab treatment in children with uncontrolled asthma and/or recurrent severe asthmatic wheeze.
Chronic rhinosinusitis with nasal polyposis (CRSwNP)
In June 2019, the FDA approved Dupixent for use with other medicines to treat CRSwNP in adults whose disease is not controlled. In October 2019, the EC approved Dupixent for use as an add-on therapy with intranasal corticosteroids in adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. In March 2020, the Japanese Pharmaceuticals and Medical Devices Agency approved Dupixent as add-on maintenance treatment for adults with inadequately controlled CRSwNP.
In September 2024, the FDA approved Dupixent (dupilumab) as an add-on maintenance treatment for adolescent patients aged 12 to 17 years with inadequately controlled CRSwNP), expanding the initial FDA approval in CRSwNP from June 2019 for patients aged 18 years and older. The FDA evaluated Dupixent for this expanded indication under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions.
Eosinophilic esophagitis (EoE)
On September 14, 2020, the FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients aged 12 years and older with EoE, and subsequently accepted the file for Priority Review on April 4, 2022. On May 20, 2022, the FDA approved Dupixent to treat patients with EoE aged 12 years and older. With this approval, Dupixent became the first and only medicine specifically indicated to treat EoE in the U.S.
On December 16, 2022, the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the approval of dupilumab in the EU to treat adults and adolescents with EoE. On January 30, 2023, the EC expanded the marketing authorization for Dupixent in the EU to include the treatment of EoE in adults and adolescents aged 12 years and older.
On July 14, 2022, a Dupixent Phase 3 study showed positive results in children aged one to 11 years with EoE, making this the fifth pediatric pivotal study across three type 2 inflammatory diseases to reinforce the well-established efficacy and safety profile of Dupixent. In January 2024, Dupixent was approved by the FDA for the treatment of adult and pediatric patients aged one year or older, weighting at least 15 kilograms, with EoE. The EoE pediatric indication was approved in the EU in November 2024.
Prurigo nodularis (PN)
The FDA evaluated the Dupixent application for PN under Priority Review on May 31, 2022. On September 29, 2022, the FDA approved Dupixent for the treatment of adult patients with PN. With this approval, Dupixent became the first and only medicine specifically indicated to treat PN in the U.S. The FDA approval was based on data from two Phase 3 studies evaluating the efficacy and safety of Dupixent in adults with PN. Efficacy in these studies assessed the proportion of subjects with clinically meaningful reduction in itching, clearing of skin, or both. On December 15, 2022, the EC expanded the marketing authorization for Dupixent in the EU to treat adults with moderate-to-severe PN who are candidates for systemic therapy, after the previous positive recommendation on November 11, 2022.
The Dupixent PN indication was approved in Japan on June 26, 2023, and in China on September 22, 2023.
Chronic spontaneous urticaria (CSU)
On July 29, 2021 a pivotal Phase 3 study evaluating Dupixent in patients with moderate-to-severe CSU met its primary endpoints and all key secondary endpoints at 24 weeks. Adding Dupixent to standard-of-care antihistamines significantly reduced itching and hives for biologic-naive patients, compared to those treated with antihistamines alone (placebo) in Study A (the first of three studies) of the LIBERTY CUPID clinical program.
Study B of the clinical study evaluated Dupixent in adults and adolescents who remain symptomatic despite standard-of-care treatment and are intolerant or incomplete responders to an anti-IgE therapeutic (omalizumab). Although positive numerical trends in reducing itching and hives were observed, the study was stopped due to futility based on a pre-specified interim analysis. Further analysis demonstrated that Dupixent met the EU primary endpoint (UAS7 at week 24). The safety data were generally consistent with the known safety profile of Dupixent in its approved indications. In December 2022, Dupixent was submitted to the FDA for the CSU indication. In October 2023, the FDA issued a Complete Response Letter (CRL) stating that additional efficacy data were required to support approval; it did not identify any issues with safety or manufacturing. Accordingly, a third clinical study (Study C) was initiated to provide additional efficacy data.
In September 2024, the Dupixent confirmatory Phase 3 study (LIBERTY-CUPID Study C) met the primary and key secondary endpoints for the investigational treatment of patients with uncontrolled, biologic-naive CSU receiving background therapy with antihistamines. This positive study confirmed results from Study A, the first Phase 3 study of Dupixent in this setting. Earlier in 2024, Japan was the first country in the world to approve and launch Dupixent for adult and adolescent CSU patients based on the results from Study A (February 2024), followed by approvals in the United Arab Emirates (UAE) (September 2024) and Brazil (November 2024).
Chronic obstructive pulmonary disease (COPD)
On July 3, 2024, following a positive review by the EMA, the EC approved Dupixent as an add-on maintenance treatment for adults with uncontrolled COPD characterized by elevated blood eosinophils. This approval covers patients already on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or those on a LABA/LAMA combination if ICS is unsuitable. The EC was the first regulatory agency worldwide to grant approval for Dupixent in COPD patients.
On September 10, 2024, a pooled analysis from the BOREAS and NOTUS Phase 3 studies showed that Dupixent reduced exacerbations and improved lung function compared to placebo in adults with uncontrolled COPD and evidence of type 2 inflammation (i.e. raised blood eosinophils). The results were presented for the first time, in collaboration with Regeneron, at the 2024 European Respiratory Society (ERS) International Congress.
On September 27, 2024, the National Medical Products Administration (NMPA) in China also approved Dupixent as an add-on treatment for adults with uncontrolled COPD and raised blood eosinophils. This approval similarly covers patients on combinations of ICS, LABA, and LAMA, or LABA and LAMA if ICS is not appropriate. Dupixent has now been approved for the treatment of COPD in over 30 countries, including the 27 EU member states.
On September 27, 2024, the FDA approved Dupixent as the first biologic treatment for COPD in the United States. This approval, which applies to adults with inadequately controlled COPD and an eosinophilic phenotype, was based on two pivotal Phase 3 studies showing significant reductions in exacerbations and improvements in lung function and quality of life compared to placebo. Dupixent has become the leading biologic in new-to-brand prescriptions across all its FDA-approved indications and is the most prescribed biologic by the U.S. pulmonologists.
Life Cycle Management
Dupixent is being evaluated in clinical development programs for diseases that are driven by type 2 inflammation. These include bullous pemphigoid (BP), chronic pruritis of unknown origin (CPUO), eosinophilic gastroenteritis (EoG), ulcerative colitis (UC) and Lichen Simplex Chronicus (LSC).
In September 2024, Dupixent became the first and only biologic to achieve significant improvements in disease remission and symptoms in bullous pemphigoid, based on positive results from a pivotal study.
Dupixent is developed and commercialized in collaboration with Regeneron.
Kevzara
Kevzara (sarilumab) is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R) and has been shown to inhibit IL-6R mediated signaling. IL-6 is a cytokine in the body that, in excess and over time, can contribute to the inflammation associated with rheumatoid arthritis (RA). Kevzara is available in 20 countries, including the U.S.
Kevzara is developed and commercialized in collaboration with Regeneron.
Rheumatoid arthritis (RA)
In June 2017, the EC granted marketing authorization for Kevzara in combination with methotrexate for the treatment of moderately to severely active RA in adult patients who have responded inadequately to – or who are intolerant to – one or more DMARDs, such as methotrexate. In September 2017, Kevzara obtained manufacturing and marketing approval in Japan as a treatment for RA not responding well to conventional treatments. In February 2023, the FDA approved Kevzara for the treatment of adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate a corticosteroid taper. In June 2024, the FDA approved Kevzara for the treatment of polyarticular Juvenile Idiopathic Arthritis. Lastly, in November 2024, the EC granted marketing authorization for Kevzara for the treatment of PMR in adult patients who have had an inadequate response to corticosteriods, or who experience a relapse on a corticosteroid taper.
Rare Diseases
Cerezyme
Cerezyme (imiglucerase) is an ERT used to treat Gaucher disease, a chronic, inherited, progressive and potentially life- threatening lysossomal storage disorders (LSD). Gaucher disease is caused by a deficiency of the enzyme glucocerebrosidase; this causes a fatty substance called glucosylceramide (also called GL-1) to build up in certain areas of the body, including the spleen, liver, and bone. Gaucher disease exhibits diverse manifestations, a broad range of onset of symptoms, and a wide clinical spectrum of disease severity. It is estimated that Gaucher disease occurs in approximately one in 120,000 newborns in the general population and one in 850 in the Ashkenazi Jewish population worldwide, but incidence and patient severity vary among regions. Cerezyme has been marketed in the U.S. since 1994, in the EU since 1997, in Japan since 1998 and in China since 2008, and is approved to treat type 1 Gaucher disease in more than 85 countries. It has also been approved to treat the systemic symptoms of type 3 Gaucher disease in most non-U.S. markets, including the EU and Japan.
Cerdelga
Cerdelga (eliglustat) is the first and only first-line oral therapy for Gaucher disease type 1 adult patients. A potent, highly specific ceramide analog inhibitor of GL-1 synthesis with broad tissue distribution, Cerdelga has demonstrated efficacy in the treatment of naive Gaucher disease patients and in patients who switch from enzyme replacement therapy. Cerdelga has been approved to treat type 1 Gaucher disease in the U.S. (2014), and in the EU and Japan (2015). It is also in development for the treatment of type 1 Gaucher disease in pediatric patients.
Myozyme and Lumizyme
Myozyme (alglucosidase alfa) is an ERT used to treat both Infantile Onset and Late Onset Pompe disease (IOPD and LOPD).
Myozyme was first approved in 2006 in the EU and has since been approved in more than 80 countries. In the U.S., alglucosidase alfa has been marketed as Lumizyme since 2010.
Nexviazyme/Nexviadyme
Nexviazyme / Nexviadyme (avalglucosidase alfa-ngpt) is a novel mannose-6-phosphate (M6P) enriched enzyme replacement therapy (ERT) treatment designed as a monotherapy for the entire spectrum of infantile-onset and late-onset Pompe disease (IOPD, LOPD), including patients who have changed treatments and naive patients, who have not received treatment previously. Nexviazyme/Nexviadyme is scientifically designed to specifically target the M6P receptor, the key pathway for ERT, to effectively clear glycogen build-up in muscle cells. It helps replace the GAA enzyme for people whose bodies do not produce enough. Investment in the clinical development of Nexviazyme is continuing, with an ongoing Phase 3 study in treatment-naive IOPD patients aged less than 12 months. Nexviazyme/Nexviadyme is administered as a monotherapy ERT every two weeks.
Nexviazyme was first approved in the U.S. by the FDA on August 6, 2021 for LOPD patients aged one year and older. On June 24, 2022, the EC granted marketing authorization for Nexviadyme as a potential new standard of care for the long-term treatment of both LOPD and IOPD. Nexviazyme/Nexviadyme has been approved in more than 59 countries and successfully launched in 32 countries, including the U.S., Germany, the U.K., other European markets, Japan and Australia. In all launched markets, the vast majority of eligible patients are being treated with Nexviazyme/Nexviadyme.
Fabrazyme
Fabrazyme (agalsidase beta) is an ERT used to treat Fabry disease (FD). FD is a multisystemic, progressive, X-linked inherited disorder of glycosphingolipid metabolism due to deficient or absent lysosomal a-galactosidase A activity resulting in progressive globotriaosylceramide (GL-3) accumulation in the lysosomes of various tissues. FD affects both genders. With age, progressive organ damage develops, leading to potentially life-threatening renal, cardiac and/or cerebrovascular complications. FD is characterized by different symptom severities and rates of progression, ranging from classic disease with early symptom onset to non-classic disease with cardiac and/or renal complications later in life. FD is seen in all racial and ethnic groups and is an under- diagnosed condition. Prevalence estimates vary across regions. Classic FD mutations are estimated to be approximately 1:40,000 in males with more wide-ranging estimates for non-classic in both males and females. Fabrazyme has been marketed in the EU since 2001 and in the U.S. since 2003 and is approved in more than 70 countries.
Aldurazyme
Aldurazyme (laronidase) is the only approved ERT for mucopolysaccharidosis type 1 (MPS I), an inherited lysosomal storage disorder caused by a deficiency of alpha-L-iduronidase, a lysosomal enzyme normally required for the breakdown of certain complex carbohydrates known as glycosaminoglycans (GAGs). MPS I is multi-systemic, and children with MPS I are described as having either a severe or attenuated form of the disorder based on age of onset, severity of symptoms, rate of disease progression and whether there is early and direct involvement of the brain. MPS I occurs in approximately one per 100,000 live births worldwide, but incidence and patient severity vary among regions. Sanofi markets Aldurazyme in the EU and the U.S. (since 2003) and in more than 75 other countries.
Xenpozyme
Xenpozyme (olipudase alfa) is an ERT designed to replace deficient or defective acid sphingomyelinase (ASMD), an enzyme that allows for the breakdown of the lipid sphingomyelin. In individuals with ASMD, an insufficiency of the ASM enzyme means sphingomyelin is poorly metabolized, potentially leading to lifelong accumulation in and damage to multiple organs. The significance of the unmet need that Xenpozyme addresses has been recognized by Japan’s PMDA with Sakigake designation, by the EU with PRIME designation, and by the FDA with Breakthrough designation.
Xenpozyme was approved first in Japan on March 28, 2022, followed by Europe on June 24, 2022 and the U.S. on August 31, 2022. Xenpozyme is the first and only ERT for the treatment of non-central nervous system manifestations of ASMD, with demonstrated improvements in hepatosplenomegaly, pulmonary, liver and hematologic function, dyslipidemia, and growth (children only) in clinical studies of adults and children with ASMD. Xenpozyme is given as an intravenous infusion once every two weeks, and the dose is based on body weight.
Xenpozyme has to date been commercialized in 25 countries, however only 15 of those have full reimbursement by payers. By 2030, it is anticipated that Xenpozyme will have been launched in many additional markets worldwide.
ALTUVIIIO
ALTUVIIIO (Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein) is a first-in-class high-sustained factor VIII therapy that is designed to extend protection from bleeds with once-weekly prophylactic dosing for adults and children with hemophilia A. Hemophilia A is a rare, x-linked genetic bleeding disorder characterized by a deficiency of functional coagulation factor VIII, resulting in a prolonged patient plasma-clotting time. As a consequence, people with hemophilia A bleed for a longer time than normal. ALTUVIIIO temporarily replaces the missing coagulation factor VIII by intravenous injection. In adults and adolescents, it is the first factor VIII therapy that has been shown to break through the von Willebrand factor ceiling, which imposes a half-life limitation on earlier generation factor VIII therapies. ALTUVIIIO builds on innovative Fc fusion technology by adding a region of von Willebrand factor and XTEN polypeptides to extend its time in circulation.
ALTUVIIIO was first approved in February 2023 by the FDA, which had previously granted Breakthrough Therapy designation in May 2022 (the first factor VIII therapy to receive this designation); fast-track designation in February 2021; and Orphan Drug designation in 2017. ALTUVIIIO has since been approved the by regulatory authorities in Japan, Taiwan, Macau and Hong Kong, and has been commercialized in Japan and Taiwan.The European Commission (EC) granted Orphan Drug designation in June 2019, and a marketing authorization application was filed with the European Medicines Agency (EMA) in May 2023. ALTUVOCT (the brand name of ALTUVIIIO in Europe) received EC marketing authorization in June 2024.
ALTUVIIIO is developed and commercialized in collaboration with Swedish Orphan Biovitrum AB (Sobi), whose territories include Europe, Russia, the Middle East, and some countries in North Africa.
Eloctate
The company market Eloctate primarily in the U.S. (since 2014), Japan, Canada, Australia, South Korea, Taiwan and Hong Kong / Macau.
Eloctate is developed and commercialized in collaboration with Swedish Orphan Biovitrum AB (Sobi), whose territories include Europe, Russia, the Middle East, and some countries in North Africa.
Alprolix
Alprolix (coagulation Factor IX (recombinant), Fc fusion protein) is an extended half-life factor IX clotting-factor therapy to control and prevent bleeding episodes in adults and children with hemophilia B. In the U.S., it is indicated for use in adults and children with hemophilia B for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.
Hemophilia B is a rare, x-linked genetic bleeding disorder characterized by a deficiency of functional coagulation Factor IX, resulting in a prolonged patient plasma-clotting time. As a consequence, people with hemophilia B bleed for a longer time than normal. Alprolix temporarily replaces the missing coagulation Factor IX by intravenous injection.
The company markets Alprolix primarily in the U.S. (since 2014), Japan, Canada, Australia, New Zealand, South Korea, Taiwan and Hong Kong/Macau.
Alprolix is developed and commercialized in collaboration with Swedish Orphan Biovitrum AB (Sobi), whose territories include Europe, Russia, the Middle East, and some countries in North Africa.
Cablivi
Cablivi (caplacizumab) is a bivalent anti-von Willebrand Factor (vWF) NANOBODY VHH for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP). Cablivi is the first therapeutic specifically indicated for the treatment of aTTP.
Acquired thrombotic thrombocytopenic purpura is an ultra-rare (3.5-4.5 episodes per million of population), life-threatening, autoimmune-based blood clotting disorder characterized by extensive clot formation in small blood vessels throughout the body, leading to severe thrombocytopenia (very low platelet count); microangiopathic hemolytic anemia (loss of red blood cells through destruction); ischemia (restricted blood supply to parts of the body); and widespread organ damage, especially in the brain and heart. Cablivi has an immediate effect on platelet adhesion and the ensuing formation and accumulation of the micro-clots. Cablivi was granted marketing authorization in Europe by the EC in September 2018; in the U.S. by the FDA in February 2019; and in Japan by the Japanese Pharmaceutical and Medical Devices Agency (PMDA) in September 2022. Cablivi is available in 26 countries, including the U.S., the majority of European countries (17), Brazil, Colombia, Japan and five Greater Gulf region states. Additional commercial launches are ongoing.
Cablivi was developed by Ablynx, a Sanofi company since mid-2018.
Enjaymo
Enjaymo (sutimlimab; formerly known as BIVV009) is a monoclonal antibody targeting the classical complement pathway (CP) specific serine protease (C1s), thereby inhibiting CP activity which is associated with a variety of immune disorders involving the presence of autoantibodies. Enjaymo is the first-and-only approved therapeutic option approved for hemolytic anemia in adult patients with cold agglutinin disease (CAD).
Enjaymo has previously received Breakthrough Therapy Designation and Orphan Drug Designations from the FDA, and orphan medicine designation from the EMA. After priority review, the medicine was approved in February 2022, in the U.S. as the first treatment in adult patients with CAD. Enjaymo was approved by the Japanese Ministry of Health, Labor and Welfare in June 2022 and granted marketing authorization by the EC in November 2022. Swissmedic, the Korean MFDS and the Israeli Ministry of Health granted marketing approval for Enjaymo in June 2023, July 2023 and October 2023, respectively.
Enjaymo is available in the U.S., Japan, Germany, Austria and the Netherlands. Additional commercial launches are ongoing.
On November 29, 2024, Sanofi sold Enjaymo (sutimlimab) to Recordati, which acquired the global rights to the product and will be responsible for all activities after acquiring marketing authorization holder (MAH) status across all markets.
Neurology
Aubagio
Aubagio (teriflunomide) is used to help manage multiple sclerosis (MS). This small molecule agent, taken once daily, works by reducing inflammation and modulating the immune system to prevent the immune attacks that cause MS symptoms.
Aubagio is approved in more than 80 countries around the world, including the U.S. (since September 2012) for the treatment of patients with relapsing forms of MS; the EU (since August 2013) for the treatment of adult patients with relapsing remitting MS; and China (since July 2018). In June 2021, the EC approved Aubagio for the treatment of pediatric patients aged 10 to 17 years with relapsing-remitting multiple sclerosis (RRMS).
In 2017, Sanofi reached settlement with all 20 generic Aubagio ANDA first filers, granting each a royalty-free license to enter the U.S. market on March 12, 2023. In the EU, the first generic competitors to Aubagio became available in September 2023.
Oncology
Sarclisa
Sarclisa (isatuximab) is a monoclonal antibody that binds a specific epitope on the human CD38 receptor and has antitumor activity via multiple mechanisms of action. It was first approved in the U.S. in March 2020 in combination with pomalidomide and dexamethasone for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor, and in Europe by the EC in May 2020 in combination with pomalidomide and dexamethasone for the treatment of adult patients with RRMM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. Sarclisa is now approved for this indication in more than 50 countries. In early 2025 Sarclisa, in combination with pomalidomide and dexamethasone, was approved by the NMPA (National Medical Products Administration) in China for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior line including lenalidomide and proteasome inhibitor.
This is the first indication of Sarclisa to be approved in China.
Sarclisa was approved in the U.S. in March 2021 for a label extension in combination with carfilzomib and dexamethasone for the treatment of adults with RRMM who have received one to three prior lines of therapy, and in Europe in April 2021 by the EC for the treatment of adult patients with MM who have received at least one prior therapy. The Japanese Ministry of Health, Labor and Welfare (MHLW) granted approval for Sarclisa in November 2021 in combination with carfilzomib and dexamethasone, in combination with dexamethasone, and as monotherapy for RRMM patients.
Sarclisa was approved in the U.S. in September 2024, in Europe in January 2025, and (as the second indication) in China in January 2025 in combination with bortezomib, lenalinomide and dexamethasone for the treatment of adults with newly diagnosed MM who are not eligible for autologous stem cell transplant (ASCT).
ANVISA, the Brazilian healthcare authority, also approved Sarclisa in the same combination for the treatment of adult patients with newly diagnosed MM who are not eligible for ASCT or with no intent for ASCT as initial therapy. This additional label has also been submitted to other regulatory authorities, and is being reviewed. In addition, the Phase 3 IRAKLIA study investigating the development of a new subcutaneous formulation with an on-body device system, which was initiated in the second half of 2022 in over 20 countries, reported positive read-outs having reached its co-primary end points. Sarclisa is also being investigated with several innovative agents in MM in an umbrella Phase 1/2 study.
Jevtana
Jevtana (cabazitaxel), a chemotherapy drug and cytotoxic agent, is a semi-synthetic second-generation taxane that prevents many cancer cells from dividing, which ultimately results in destroying many such cells. It is approved in combination with prednisone for the treatment of patients with metastatic castration resistant prostate cancer previously treated with a docetaxel- containing treatment regimen. Jevtana was granted marketing authorization by the FDA in June 2010, by the EC in March 2011, and in Japan in July 2014. The medicine is marketed in over 75 countries. In Europe, generic competition started for Jevtana from the end of March 2021. In the U.S., the Jevtana composition of matter patent expired in September 2021. Sanofi has filed patent infringement suits under the U.S. Hatch-Waxman Act against generic manufacturers for cabazitaxel in the U.S. District Court for the District of Delaware asserting three Orange Book listed U.S. patents for Jevtana. Sanofi entered into settlement agreements with most of the defendants and went to trial against the remaining defendant, Sandoz, on one of the patents in January 2023; see Note D.22.b. to the consolidated financial statements, included at Item 18. of this annual report. The district court issued a final judgment in favor of Sanofi in connection with the Jevtana patent litigation against Sandoz in June 2023, and on August 2, 2023, Sandoz appealed to the Court of Appeals for the Federal Circuit. On October 5, 2023, Sanofi and Sandoz filed a joint stipulation voluntarily dismissing Sandoz’s Appeal, bringing this matter to conclusion.
Fasturtec/Elitek
Fasturtec/Elitek is used for the management of plasma uric levels in patients with leukemia, lymphoma, and solid tumor malignancies receiving anticancer therapies.
Other medicines
Lantus
Lantus (insulin glargine 100 units/mL) is a long-acting analog of human insulin, indicated for once-daily administration for the treatment of diabetes mellitus in adults, adolescents and children aged two years and above. Lantus relies on more than 20 years of clinical evidence in diabetes treatment and a well-established safety profile. Approved in the U.S. and the EU in 2000 and in Japan in 2008, Lantus is available in over 130 countries worldwide. Two insulin glargine biosimilars are available in the U.S., two in European markets, and two in Japan.
Toujeo
Toujeo (insulin glargine 300 units/mL) is a long-acting analog of human insulin, indicated for the treatment of diabetes mellitus in adults. Toujeo has been granted marketing authorization by the FDA (February 2015), the EC (April 2015), and the Ministry of Health, Labor and Welfare (J-MHLW) in Japan, where its approved brand name is Lantus XR (July 2015). Toujeo has now been launched in more than 60 countries, including China since the end of 2020. In January 2020, the EC approved an expansion of the indication to include the treatment of diabetes in adolescents and children (aged six years and above).
Toujeo is available in Toujeo Solostar, a disposable prefilled pen which contains 450 units of insulin glargine and requires one- third of the injection volume to deliver the same number of insulin units as Lantus Solostar. In the U.S. (since 2018) and the EU (since 2019), Toujeo is also available in a disposable prefilled pen which contains 900 units of insulin glargine. In India, Toujeo is also available in a dedicated 450-unit cartridge in combination with a dedicated reusable pen (TouStar).
Lovenox/Clexane
Lovenox or Clexane (enoxaparin sodium) is a low molecular weight heparin (LMWH) indicated for the prophylaxis and treatment of venous thromboembolism and in the treatment of acute coronary syndrome. In the U.S., enoxaparin generics are available, while biosimilar enoxaparin medicines have gradually become available across various European countries and in a growing number of international markets, including China. Lovenox or Clexane is marketed in more than 100 countries.
Plavix/Iscover
Plavix or Iscover (clopidogrel bisulfate) is a platelet adenosine diphosphate (ADP) receptor antagonist. It is indicated for the prevention of atherothrombotic events in patients with a history of recent myocardial infarction (MI), recent ischemic stroke or established peripheral arterial disease (PAD), and for patients with acute coronary syndrome (ACS). Plavix is also indicated in combination with acetylsalicylic acid (ASA) for the prevention of atherothrombotic and thromboembolic events in atrial fibrillation, including stroke.
CoPlavix/DuoPlavin, a fixed-dose combination of clopidogrel bisulfate and ASA, is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome who are already taking both clopidogrel and ASA. Several clopidogrel bisulfate generics have been launched in most markets. Plavix or Iscover are available in more than 110 countries.
Sanofi is involved in two Plavix medicine lawsuits.
Rezurock
Rezurock (belumosudil) is a first-in-class selective ROCK2 (rho-associated coiled-coil–containing protein kinase-2) inhibitor. It was approved in July 2021 by the FDA for the treatment of adult and pediatric patients aged 12 years and older with chronic graft- versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy. In addition to robust adoption in the United States, Rezurock has been launched in 10 countries, including Canada, the United Kingdom, China, Japan, and South Korea (marketed in Japan and South Korea by partner Romeck Pharma). Early access or managed access programs are available in 28 countries, including European Union countries and Turkey. On November 28, 2024, Sanofi achieved the inclusion of Rezurock on the new National Reimbursement Drug List in China, via a thorough process recognizing the clinical and pharma-economic value of the medicine. The new list became effective on January 1, 2025. Rezurock’s favorable market adoption, longer durability of response, and recent three-year safety publication, especially in the U.S. patients, are a reflection of its clinical profile. Sanofi is developing an oral suspension to support pediatric studies. Two belumosudil Phase 3 clinical studies are enrolling patients for the treatment of (i) newly diagnosed cGVHD patients and (ii) chronic lung allograft dysfunction (CLAD) post bilateral lung transplant. There are no approved targeted therapies for either newly diagnosed cGVHD or CLAD.
Praluent
Praluent (alirocumab) is a human monoclonal antibody (mAb) for self-administered injection every two weeks or once-monthly. It blocks the interaction of proprotein convertase subtilisin/kexin type 9 (PCSK9) with low-density lipoprotein (LDL) receptors, increasing the recycling of LDL receptors and reducing LDL cholesterol levels. Praluent is indicated as an adjunct to diet and maximally tolerated statin therapy in certain adult patients and in pediatric patients eight years of age and older with heterozygous familial hypercholesterolaemia (HeFH) with uncontrolled LDL cholesterol. Praluent has been approved in more than 60 countries worldwide, including the U.S. (in 2015), Canada and Switzerland, as well as in the European Union (in 2015). In 2018, the FDA approved a Praluent label update for patients requiring LDL apheresis therapy. In March 2019 in the EU and in April 2019 in the U.S., Praluent was approved for use in patients with established cardiovascular disease to reduce the risk of cardiovascular events. In November 2023, following positive review by EMA, the EC approved a Praluent label update for pediatric HeFh patients aged eight years and older. In December 2019, Praluent was approved in China, where it started to be commercialized in May 2020. Since April 2020, Regeneron has been responsible for commercialization of Praluent in the U.S., and Sanofi has been responsible for all other markets outside the U.S.
Thymoglobulin
Thymoglobulin (anti-thymocyte globulin) is a polyclonal anti-human thymocyte antibody preparation that acts as a broad immunosuppressive and immunomodulating agent. In the U.S., Thymoglobulin is indicated for the prophylaxis and/or treatment of acute rejection in patients receiving a kidney transplant, used in conjunction with concomitant immunosuppression. Outside the U.S., depending on the country, Thymoglobulin is indicated for the treatment and/or prevention of acute rejection in organ transplantation; immunosuppressive therapy in aplastic anemia; and the treatment and/or prevention of Graft-versus-Host Disease (GvHD) after allogeneic hematopoietic stem cell transplantation. Thymoglobulin is marketed in over 65 countries.
Aprovel/Avapro/Karvea
Aprovel, also known as Avapro or Karvea (irbesartan), is an angiotensin II receptor antagonist indicated in the treatment of hypertension and for the treatment of renal disease in patients with hypertension and type 2 diabetes. Sanofi also markets CoAprovel/Avalide/Karvezide, a combination of irbesartan and the diuretic hydrochlorothiazide. A combination with amlodipine (Aprovasc, Aprexevo, Aproxxamlo) has been launched in several countries.
A number of irbesartan generics have been launched in most markets. Aprovel and CoAprovel are marketed in more than 80 countries. In Japan, the medicine is licensed to Shionogi Co. Ltd and BMS KK. BMS KK has sublicensed the agreement to Dainippon Pharma Co. Ltd.
Multaq
Multaq (dronedarone) is an oral multichannel blocker with anti-arrhythmic properties for prevention of atrial fibrillation recurrences in certain patients with a history of paroxysmal or persistent atrial fibrillation. Multaq was approved in the U.S. and in the EU in 2009. Multaq is available in approximately 35 countries.
Soliqua – Suliqua
Soliqua 100/33 or Suliqua is a once-daily fixed-ratio combination of insulin glargine 100 Units/mL, a long-acting analog of human insulin, and lixisenatide, a GLP-1 receptor agonist. The FDA approved Soliqua 100/33 in November 2016 for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 units daily) or lixisenatide; and in February 2019 for patients uncontrolled on oral antidiabetic medicines. In January 2017, Suliqua (the medicine’s brand name in Europe) was approved for use in combination with metformin with or without SGLT-2 inhibitors for the treatment of adults with type 2 diabetes to improve glycemic control, when this had not been provided either by metformin alone or by metformin combined with another oral glucose-lowering medicine or with basal insulin. In Japan, Soliqua was approved in May 2020 for type 2 diabetes mellitus, where treatment with insulin is required. In China, Soliqua was approved in January 2023 for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycemic control as an adjunct to diet and exercise in addition to other oral antidiabetic drugs. Soliqua received National Reimbursement Drug List (NRDL) status in China in December 2023. Suliqua is available in over 40 countries. Soliqua is approved in over 80 countries.
Mozobil
Mozobil (plerixafor injection) is a hematopoietic stem cell mobilizer. It is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma (NHL) and MM. Mozobil is marketed in over 65 countries. Generic Mozobil has been available in the U.S. since the end of 2023, and in Europe since 2024.
Tzield
Tzield (Teplizumab) is a CD3-directed antibody (CD3 is a cell surface antigen present on T lymphocytes). It was approved by the FDA in November 2022 to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged eight years and older with Stage 2 type 1 diabetes. The medicine is marketed in the United States, and approved in Israel and the United Arab Emirates in this indication, with plans for pursuing regulatory approval in other regions such as the EU, China and Japan. The medicine is in development for further indications for the treatment of patients already in Stage 3 (clinical onset) type 1 diabetes, as well as for pediatric patients ages 0-7 at Stages 2 and 3 type 1 diabetes. Early access programs and Managed Access Programs are available in France, Germany, Israel, Spain, the U.K. and China.
Vaccines
The Vaccines division of Sanofi is a world leader in the vaccine industry and a key supplier of life-saving vaccines all over the world and for publicly funded international stakeholders such as UNICEF, the Pan American Health Organization (PAHO) and the Global Alliance for Vaccines and Immunization (GAVI).
The Vaccines portfolio includes the following products:
Influenza vaccines
Sanofi is a world leader in the production and marketing of influenza vaccines, offering several distinct influenza vaccines that are sold globally.
As influenza strains vary from one season to the next, the World Health Organization (WHO) selects the strains to be included in influenza vaccines for each season. In 2024, the WHO decided to move from quadrivalent influenza vaccines including two A strains and two B strains back to trivalent influenza vaccines including two A strains and one B strain, as it was considered that the B Yamagata strains were not responsible for a significant burden in past seasons. All manufacturers will therefore progressively move back from quadrivalent to trivalent influenza vaccines in the coming seasons. In 2024, Sanofi commercialized trivalent influenza vaccines in the U.S., and quadrivalent influenza vaccines in all other countries. The switch to trivalent will happen in all other countries in the upcoming seasons.
Fluzone Quadrivalent is a quadrivalent inactivated influenza vaccine, produced in the U.S., containing two type A antigens and two type B antigens in order to provide increased protection against more circulating strains of influenza viruses. Fluzone Quadrivalent/FluQuadri is available in seven countries (including the U.S.) for children aged over six months, adolescents and adults. Fluzone 0.5 ml QIV is the currently-licensed standard dose (15 µg/strain) quadrivalent influenza vaccine for ages six months and older. Fluzone trivalent is the same vaccine but includes two A strains and only one B strain.
Fluzone High-Dose Quadrivalent, designed specifically to provide greater protection against influenza for people aged 65 years and older, was approved by the FDA in November 2019. Fluzone High-Dose Quadrivalent was approved in the EU in the second quarter of 2020, under the name Efluelda, indicated for adults aged 60 years and above. Both Fluzone High-Dose Quadrivalent and Efluelda have been available since the 2020/21 influenza season. To date, this vaccine has been distributed to more than 25 countries worldwide. Fluzone HD/Efluelda trivalent is the same vaccine but includes two A strains and only one B strain.
Flublok is a quadrivalent recombinant protein-based influenza vaccine indicated for adults aged 18 and older. Flublok is licensed in the U.S., Hong Kong and Australia. This same recombinant protein-based influenza vaccine is also licensed under the brand name Supemtek in Canada, the United Kingdom, the European Union and Switzerland. Flublok will also switch to trivalent following the new WHO recommendation.
Vaxigrip is a trivalent influenza vaccine, containing two antigens against type A influenza viruses and one antigen against type B influenza viruses.
VaxigripTetra is the quadrivalent (QIV) version of Vaxigrip, including two antigens against A strains of influenza viruses and two antigens against B strains, and is produced in France. Vaxigrip Tetra was licensed in 2016 and has been approved in 95 countries. It is not licensed in the U.S. where Fluzone Quadrivalent, which is produced in the U.S., is distributed. Following the new WHO recommendations, countries will switch back to Vaxigrip (trivalent) in the coming seasons.
COVID Vaccine
From 2025 onwards, Sanofi will commercialize the recombinant adjuvanted COVID-19 vaccine from Novavax.
Poliomyelitis, pertussis and Haemophilus influenzae type b (Hib) pediatric vaccines
Sanofi is one of the key players in pediatric vaccines in both developed and emerging markets, with a broad portfolio of standalone and combination vaccines protecting against up to six diseases in a single injection. Due to the diversity of immunization schedules throughout the world, vaccines can be either quadrivalent, pentavalent, or hexavalent according to regional specificities.
Tetraxim, a pediatric combination vaccine protecting against diphtheria, tetanus, pertussis and poliomyelitis (polio), was first marketed in 1998. To date, the vaccine has been launched in close to 100 countries (this vaccine is not marketed in the U.S.). Pentaxim, a pediatric combination vaccine protecting against diphtheria, tetanus, pertussis, polio and Hemophilus influenzae type b (Hib), was first marketed in 1997. To date, the vaccine has been launched in more than 90 countries (this vaccine is not marketed in the U.S.). In most European, Latin American, Asian and the Middle Eastern markets, Pentaxim is being gradually replaced by Hexaxim.
Hexaxim/Hexyon/Hexacima is a fully liquid, ready-to-use 6-in-1 (hexavalent) pediatric combination vaccine that provides protection against diphtheria, tetanus, pertussis, polio, Hib and hepatitis B. Hexaxim is the only combination vaccine including acellular pertussis (acP) and inactivated polio vaccines (IPV) prequalified by the WHO. First marketed in 2013, Hexaxim is now available in more than 100 countries outside the U.S.
Pentacel, a pediatric combination vaccine protecting against diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b (Hib), was launched in the U.S. in 2008.
Quadracel is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis, used in children aged four through six years as a fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series, and as a fourth or fifth dose in the IPV series. It was launched in the U.S. in 2017.
ACT-HIB is a standalone vaccine protecting against Hib, and is mainly distributed in the U.S. and in Japan in conjunction with pertussis combination vaccines that do not contain the Hib valence.
Sanofi is a leading provider of polio vaccines and has been a partner of the Global Polio Eradication Initiative (GPEI) for over 30 years. Since Sanofi launched its first IPV, more than 1.5 billion doses have been distributed worldwide.
Vaxelis
Vaxelis is a hexavalent combination vaccine protecting against diphtheria, tetanus, pertussis, polio, Hib and hepatitis B. This vaccine (developed and distributed in partnership with Merck) was approved in 2016 by the EC and is distributed in various EU countries. Vaxelis was approved by the FDA in December 2018, becoming the first hexavalent vaccine to be approved in the U.S., and launched in this country in June 2021.
Sales of Vaxelis in the U.S. are recognized by the Merck Sanofi Pasteur joint venture and credited equally to Merck and Sanofi as income from equity affiliates.
Booster vaccines
Adacel is the leading trivalent booster vaccine offering protection against diphtheria, tetanus and pertussis. The vaccine can be used from four years of age following primary immunization and is the first Tdap vaccine indicated for use during pregnancy for protection against pertussis in newborns. It is available in 71 countries, including the U.S. and other countries mostly in Europe, Asia and Latin America. Recently, Adacel has been introduced in additional countries that are implementing new vaccination programs, particularly focusing on maternal immunization.
Repevax/Adacel-Polio is a combination vaccine that provides protection against diphtheria, tetanus, pertussis and polio. It is the first Tdap-IPV vaccine indicated for use during pregnancy for protection against pertussis in newborns. It is marketed in 25 countries outside the U.S., with a strong focus on European markets (such as France and Germany).
Respiratory syncytial virus (RSV) protection
In 2023, Sanofi launched Beyfortus (nirsevimab-alip), a long-acting monoclonal antibody designed to protect against RSV. It is indicated for the protection of neonates and infants born during or entering their first RSV season, and for children up to 24 months who remain particularly vulnerable to severe RSV in their second RSV season.
Beyfortus is licensed in numerous countries and has now been launched in more than 20 countries, including in North America, Europe, China and Japan. Real world data from countries such as the U.S., Spain and France have confirmed and even surpassed the outstanding efficacy data generated during the clinical development of this monoclonal antibody. Many more countries are expected to implement all-infant protection in the future. Sanofi and AstraZeneca entered into an agreement in 2017 to develop and commercialize Beyfortus, under which AstraZeneca leads development and manufacturing activities and Sanofi leads commercialization activities and records revenues. Sanofi will continue to expand Beyfortus in new geographies across Europe, Asia and Latin America.
Meningitis and travel & endemic vaccines
Menactra, the first quadrivalent conjugate vaccine against meningococcal meningitis (serogroups: A, C, Y, and W-135), one of the deadliest forms of meningitis, is indicated for people aged nine months through 55 years. Since launch, it has become a strong leader in the meningitis quadrivalent market. It is commercialized in a large number of countries (excluding Europe). Menactra was the first fully liquid (no reconstitution needed) meningitis quadrivalent conjugated vaccine, and more than 100 million doses of this vaccine have been distributed since launch.
MenQuadfi is a novel fully-liquid meningococcal quadrivalent conjugated vaccine expected to have a broad age indication from infants (six weeks) to the elderly, with flexible dosing schedules. MenQuadfi is the first and only quadrivalent ACWY vaccine to demonstrate superior immune response against serogroup C in toddlers compared to a monovalent serogroup C vaccine (standard-of-care in multiple markets in Europe and internationally). MenQuadfi will progressively fully replace Menactra. It is already available in the U.S. (for people over two years of age), and in Australia, Canada, Europe, Japan, Argentina, Brazil, and Chile for people aged 12 months and above. Marketing authorization is also pending in numerous other countries. Extension of the age indication down to six weeks of age will follow submission of additional Phase 3 data.
Sanofi provides a wide range of travel and endemic vaccines including yellow fever, rabies, typhoid and hepatitis A vaccines. These vaccines are used in endemic settings in the developing world and are the foundation for important partnerships with governments and organizations such as UNICEF. They are also used by travelers and military personnel in industrialized countries and in endemic areas.
Opella
The implementation and simplification of Sanofi's autonomous Opella business unit continued in 2024. Mainly as a result of divestments, the portfolio was further reduced to approximately 100 brands by the end of the year.
Opella operates in 100 countries and manages 13 strategic production sites, as well as four research and innovation centers, with a portfolio of leading brands.
In October 2024, in line with its strategy of focusing on innovative medicines and vaccines, Sanofi announced that it had entered into exclusive negotiations for the sale of a controlling stake of around 50% in Opella. The agreements in connection with the potential sale and purchase of a 50% controlling stake in Opella are described as follows:
Products in development
The pipeline of products in clinical development is focused on medicines and vaccines seen as potential market leading opportunities, among which amlitelimab, frexalimab and balinatunfib are ‘pipeline-in-a-product’ medicines and vaccines.
Immunology & Inflammation
amlitelimab (SAR445229), a human monoclonal antibody blocking OX40L pathway, is a ‘pipeline-in-a-product’ asset being assessed in clinical programs for the treatment of a range of immune diseases.
In AD, the dosing of once every 12 weeks is being assessed in a large Phase 3 clinical program (OCEANA). Enrollment of the four main AD studies designed to evaluate on- and off-treatment efficacy and safety in adults and adolescents continued in 2024, with results supporting subsequent regulatory submission (expected in 2026).
The proof-of concept Phase 2 study (TIDE-Asthma) assessing amlitelimab in moderate-to-severe asthma has a 60-week double- blind placebo-controlled period, in which patients are dosed once every four weeks during the initial 24 weeks and once every 12 weeks for the subsequent 36 weeks. Sanofi anticipates results for the full and completed 60-week treatment and follow-up period will be available in the first half of 2025.
The Phase 2 study of amlitelimab in hidradenitis suppurativa (HS) recruited its last patient in 2024; results are expected in the first half of 2025.
In 2024, additional Phase 2 studies assessing the efficacy and safety of subcutaneous injections of amlitelimab enrolled their first patients in adults with non-responsive celiac disease, severe alopecia areata and systemic sclerosis, respectively.
frexalimab (SAR441344) is a second generation anti-CD40L monoclonal antibody that blocks the costimulatory CD40/CD40L pathway, which is important for the activation and function of adaptive (T and B cells) and innate (macrophages/microglia and dendritic cells) immunity. Sanofi is developing frexalimab under an exclusive license from ImmuNext Inc.
Frexalimab is a ‘pipeline-in-a-product’ asset being evaluated in Phase 3 studies for the treatment of MS, and in Phase 2 studies for the treatment of systemic lupus erythematosus and adults and adolescents with newly diagnosed type 1 diabetes. In 2024, the clinical development of frexalimab in Sjogren’s syndrome was discontinued based on results from the Phase 2 study; the data confirmed pharmacological activity and a well-tolerated safety profile, but not the necessary efficacy outcomes to continue to move the development forward in this indication.
balinatunfib (SAR441566) the first small molecule TNFR1 signaling inhibitor, is intended to provide patients with an oral alternative to anti-TNFa monoclonal antibodies in the range of inflammatory indications where these have been approved. Balinatunfib is a ‘pipeline-in-a-product’ asset being evaluated in two Phase 2b clinical studies for the treatment of psoriasis and RA, respectively. In these two indications, results are expected in the first and second half of 2025, respectively. In 2024, a Phase 2 study was initiated to assess balinatunfib in adults with moderate-to-severe Crohn’s disease.
itepekimab (SAR440340) is a human anti-IL33 monoclonal antibody co-developed with Regeneron. A Phase 3 clinical program is evaluating itepekimab for the treatment of COPD in former smokers (AERIFY-1 and AERIFY-2 studies) and in current smokers (AERIFY-2); results are expected in the second half of 2025. In addition, an exploratory Phase 2a study (AERIFY-3) is evaluating the mechanism of action of itepekimab and its impact on airway inflammation in former and current smokers with COPD. Itepekimab has FDA fast-track designation for the treatment of COPD. In 2024, an additional Phase 2 study evaluating itepekimab for the treatment of patients with bronchiectasis was initiated.
rilzabrutinib (SAR444671) is a covalent and reversible inhibitor of Bruton’s tyrosine kinase under evaluation in multiple clinical studies across a range of autoimmune/inflammatory indications.
Positive results were obtained in 2024 from the RILECSU Phase 2 study, showing that rilzabrutinib significantly improved itch, hives and urticaria in adults with moderate-to-severe CSU whose symptoms are not adequately controlled by H1-antihistamines; the indication will be further investigated in Phase 3.
Encouraging results from a Phase 2 study showed that treatment with rilzabrutinib at both high and low doses led to a numerical reduction in loss of asthma control events (the primary endpoint) and improvements in symptoms in adults with uncontrolled moderate-to-severe asthma.
In the last quarter of 2024, the 52-week open-label two-cohort Phase 2 study of rilzabrutinib in IgG4-related disease showed considerable outcomes on flare-free, steroid-free disease rates.
In addition, rilzabrutinib is being evaluated for the treatment of immune thrombocytopenia and warm autoimmune hemolytic anemia.
lunsekimig (SAR443765) is a bispecific NANOBODY VHH which blocks both TSLP and IL-13, key upstream and downstream mediators (respectively) of asthma. A Phase 2b study (AIRCULES) is assessing the efficacy, safety, and tolerability of add-on therapy with lunsekimig in adults with moderate-to-severe asthma. In 2024, two additional Phase 2 studies were initiated to assess lunsekimig (i) in adults with asthma who are not eligible for biologic treatments (high-risk asthma), and (ii) in adults with CRSwNP.
SAR444656 is a selective, orally administered small molecule targeting Interleukin-1 Receptor Associated Kinase 4 (IRAK4), which is necessary for proinflammatory signaling and cytokine production. SAR444656 is developed in partnership with Kymera Therapeutics. Two Phase 2 studies are evaluating SAR444656 for the treatment of AD and hidradenitis suppurativa (HS), respectively.
duvakitug (SAR447189, also known as TEV-48574) is an anti-TL1A monoclonal antibody co-developed with Teva Pharmaceuticals. In 2024, the companies announced that the RELIEVE UCCD Phase 2b study had met its primary endpoints in patients with ulcerative colitis (UC) and Crohn’s disease, the two main types of inflammatory bowel disease (IBD). Sanofi and Teva plan to initiate Phase 3 development in IBD, pending regulatory discussions.
eclitasertib (SAR443122) is a small molecule targeting the receptor-interacting serine/threonine-protein kinase 1 (RIPK1), which is being co-developed with Denali. The Phase 2 RESOLUTE study evaluating eclitasertib in patients with moderate to severe UC is ongoing.
riliprubart (SAR445088) is a humanized IgG4 monoclonal antibody that binds to and inhibits C1s, thereby inhibiting classical pathway (CP) of complement activity. Activation of the CP of complement is associated with a variety of immune disorders involving the presence of autoantibodies. The asset is under clinical development in various indications. A Phase 2 study is evaluating the efficacy of riliprubart in prevention of antibody-mediated rejection (AMR) or treatment of active AMR.
brivekimig (SAR442970) is a bispecific NANOBODY molecule that combines blockades of TNFa and of the immune co- stimulatory regulator OX40L. A Phase 2 study is assessing brivekimig in adults with moderate to severe HS; results are expected in the first half of 2025.
Other assets are being evaluated in Phase 1 clinical studies for subsequent development in inflammatory indications:
SAR444336, a non-beta IL2 Synthorin molecule designed to selectively engage CD4+ regulatory T cells (and not on effector T or NK cells).
SAR445399, a monoclonal antibody targeting IL1R3.
SAR446422, a bispecific antibody targeting CD28 and OX40.
SAR446959, a NANOBODY molecule targeting Matrix Metallopeptidase 13 (MMP13), A Disintegrin And Metalloproteinase with Thrombospondin Motifs 5 (ADAMTS5) and a cartilage anchoring protein (CAP).
Rare Diseases
fitusiran (SAR439774) is a first-in-class, subcutaneously administered antithrombin siRNA therapy. The FDA granted fitusiran breakthrough therapy and fast-track designations for hemophilia A/B. Fitusiran also obtained orphan drug designation in the U.S. and in Europe. In 2024, regulatory submissions for the treatment of hemophilia A or B in adults and adolescents with or without inhibitors were completed in several regions, including the U.S. with a prescription drug user fee act (PDUFA) date of March 28, 2025. In addition, Sanofi’s collaboration partner Siemens Healthineers submitted the INNOVANCE Antithrombin Assay for FDA review as a companion diagnostic that will measure antithrombin levels in people living with hemophilia who are prescribed fitusiran.
rilzabrutinib (SAR444671) is a Bruton’s tyrosine kinase inhibitor developed for the treatment of immune thrombocytopenia (ITP), for which the FDA has granted fast-track designation. The asset has also obtained orphan drug designation in the U.S., Europe, and Japan. The primary endpoint of durable platelet response was met in the rilzabrutinib Phase 3 study LUNA 3 in adult patients with persistent or chronic ITP. Other key secondary endpoints were met, including reduced bleeding, number of weeks with platelet response, the need for rescue therapy use, and improved physical fatigue and quality of life measures. The safety profile of rilzabrutinib was favorable and consistent with that reported in previous studies. Rilzabrutinib is under regulatory review in the EU, China, and the U.S. with a target date to receive an FDA decision on August 29, 2025.
In 2024, a Phase 2 study in warm autoimmune hemolytic anemia read out positively with clinically meaningful outcomes on response rate and additional disease markers. The results of this study build on the successful Phase 3 study of rilzabrutinib in ITP and reinforce its efficacy in autoimmune cytopenias.
venglustat (GZ402671) is an orally administered brain penetrant glucosylceramide synthase (GCS) inhibitor that blocks the conversion of ceramide to glucosylceramide (GL-1). In 2024, the AMETHIST Phase 3 study of venglustat for the treatment of GM2 gangliosidosis was discontinued based on the absence of positive trends on clinical endpoints. The data reinforced the favorable safety profile and do not impact the other two indications, FD and Gaucher disease type 3, in which venglustat is being evaluated in Phase 3 studies. Results in these two indications are expected in the second half of 2025. Orphan drug designation has been granted in the U.S., Europe, and Japan for FD and Gaucher disease type 3, and the FDA has granted venglustat fast- track designation for FD.
SAR447537 (formerly INBRX-101): in May 2024, the acquisition of Inhibrx, Inc. closed, adding SAR447537 to Sanofi’s rare disease Phase 2 pipeline. SAR447537 is a human recombinant protein that holds the promise of allowing alpha-1 antitrypsin deficiency (AATD) patients to achieve normalization of serum AAT levels with less frequent dosing. AATD is an inherited rare disease characterized by low levels of AAT protein, predominantly affecting the lung with progressive deterioration of the tissue. Results from the ongoing Phase 2 study (ELEVAATE) are expected in the second half of 2025. The FDA has granted SAR447537 fast- track designation for AATD.
In 2024, the decision was taken to discontinue the development of riliprubart in cold agglutinin disease, a rare autoimmune disorder characterized by the premature destruction of red blood cells (hemolysis), due to prioritization of other projects. As of now, the data confirmed pharmacological activity and a well-tolerated safety profile, as in other indications.
Neurology
tolebrutinib (SAR442168) is an oral investigational brain-penetrant and bioactive Bruton’s tyrosine kinase (BTK) inhibitor, which achieves cerebrospinal fluid concentrations that are predicted to modulate B lymphocytes and microglial cells.
Positive results from the HERCULES Phase 3 study showed that tolebrutinib met the primary endpoint of improvement over placebo in delaying time to onset of confirmed disability progression in subjects with non-relapsing secondary progressive multiple sclerosis (nrSPMS). Preliminary analysis of liver safety was consistent with previous tolebrutinib studies. In December, the FDA granted breakthrough therapy designation to tolebrutinib for the treatment of adults with nrSPMS. Sanofi expects to receive regulatory submission acceptance in the U.S. during the first half of 2025; EU submission is also anticipated during the first half of 2025. Results from the GEMINI 1 and 2 Phase 3 studies evaluating tolebrutinib did not meet the primary endpoint of reducing annualized relapse rate, compared to Aubagio, a standard of care treatment, in people with relapsing MS (RMS). However, analysis of the key secondary endpoint of pooled 6-month CDW data showed a considerable delay in time to onset, which supports the CDP data observed in HERCULES.
A Phase 3 study (PERSEUS) is ongoing to determine the efficacy of tolebrutinib in delaying disability progression in primary progressive multiple sclerosis (PPMS); results are expected in the second half of 2025 with subsequent submissions anticipated in 2026.
frexalimab (SAR441344) is a monoclonal antibody targeting CD40L that has the potential to address both acute and chronic neuroinflammation in MS through its unique upstream mechanism of action. In 2024, new efficacy and safety data at 18 months from the Phase 2 study for the treatment of RMS demonstrated sustained reduction of disease activity, with stable clinical surrogate endpoints, and good tolerance, with no new safety signals. These results support the ongoing Phase 3 clinical program, with two studies in RMS and nrSPMS.
riliprubart (SAR445088) is a complement C1s inhibitor that is being assessed in patients with chronic inflammatory demyelinating polyneuropathy (CIDP), for which orphan drug designation was granted in the U.S. and in Europe. In 2024, new data from a Phase 2 study showed encouraging efficacy and safety for patients with CIDP. In part A results at 24 weeks, riliprubart showed promising disease-controlling benefits, with most study patients improving or remaining stable, including those who experienced failure or inadequate response to standard-of-care treatment (SOC-refractory), and those having residual disability despite treatment with SOC (IVIg-treated). In part B, after approximately one year of treatment, riliprubart continued to show promising disease-controlling benefits across all enrolled cohorts. Additional results indicated that riliprubart may improve patient-reported fatigue and quality-of-life measurements as well as biomarkers associated with CIDP disease progression. Supported by the Phase 2 data, two Phase 3 studies evaluating riliprubart in SOC- refractory CIDP (MOBILIZE) and IVIg-treated CIDP (VITALIZE) were initiated.
SAR446159, a bispecific antibody targeting alpha-synuclein and insulin-like growth factor 1 receptor (IGF1R) developed in collaboration with ABL Bio for the treatment of Parkinson’s disease, is under evaluation in a Phase 1 study.
Oncology
SAR443579 is a trifunctional anti-CD123 NK cell engager developed in partnership with Innate Pharma. The asset is being investigated in a Sanofi-sponsored Phase 1/2 clinical study in various hematological malignancies, including acute myeloid leukemia for which FDA fast-track designation was obtained. In 2024, SAR443579 progressed to the Phase 2 dose expansion part of the study.
SAR447873 is a somatostatin receptor (SSTR)-targeting alpha-emitter therapy that entered Sanofi’s pipeline in 2024 through partnership with RadioMedix and OranoMed. The AlphaMedix02 Phase 2 study is evaluating SAR447873 in subjects with SSTR-expressing neuroendocrine tumors; results from this study are expected in the first half of 2025. The asset was granted breakthrough therapy designation in gastroenteropancreatic neuroendocrine tumors from the FDA for patients who are naive to peptide-receptor radionuclide therapy.
In addition, Sanofi’s clinical pipeline includes several assets being evaluated in Phase 1 for the treatment of various cancer settings:
SAR444881, a monoclonal antibody targeting the Ig-like transcript 2 (ILT2) receptor, co-developed with Biond Biologics for the treatment of solid tumors.
SAR445877, an anti-PD1xIL15 fusion protein under assessment in patients with solid tumors.
SAR445514, a trifunctional anti-BCMA NK cell engager, developed in partnership with Innate Pharma for the treatment of relapsed or refractory multiple myeloma.
SAR445953, an antibody drug conjugate that binds to human CEACAM-5 under evaluation for the treatment of colorectal cancer or other solid tumors. SAR445953 is developed in collaboration with Pfizer.
Vaccines
SP0087 is a purified human rabies vaccine aimed at replacing Sanofi’s commercialized rabies vaccines (Imovax and Verorab). This next generation rabies vaccine is cultured on Vero cells and is free from animal or human material. The asset is under evaluation in a Phase 3 study for pre- and post-exposure prophylaxis in all age groups; results from this pivotal study are expected in the first half of 2025. The FDA has granted SP0087 fast-track designation.
SP0125 is a live attenuated vaccine intended to expand protection against RSV to all toddlers, from the second season onwards (all infants can indeed be protected against RSV during their first season with Beyfortus, which is available in the U.S. and several other countries. In 2024, a Phase 3 study (PEARL) was initiated to evaluate SP0125 for the prevention of RSV in toddlers; the study is being conducted in approximately 6,300 children aged six months to less than 22 months. SP0125 has been granted fast-track designation by the FDA and PRIME designation by the EU.
SP0202 is a 21-valent conjugate vaccine intended to provide expanded protection against pneumococcal disease, developed in collaboration with SK bioscience. In 2024, a Phase 3 program was initiated for SP0202, which is the first pneumococcal conjugate vaccine candidate with more than 20 serotypes to enter this clinical stage in infants and toddlers. The Phase 3 program will include more than 7,700 infants, toddlers, young children, and adolescents across multiple geographies, including the U.S., Europe, Australia, Asia, and Latin America. The FDA has granted SP0202 fast-track designation.
SP0256 is an mRNA vaccine candidate intended to prevent RSV and human metapneumovirus (hMPV) infections in the older adult population. A Phase 1/2 study is ongoing to evaluate this combination vaccine, for which the FDA has granted fast-track designation to prevent RSV and hMPV infections in people aged 60 to 75 years.
SP0218 is a live attenuated yellow fever vaccine (freeze-dried and produced in Vero cells), for subcutaneous and intra-muscular administration in people aged nine months and older. This next generation vaccine aims at replacing Stamaril (licensed in 1983) and YF-VAX (licensed in 1970), thereby securing a sustainable and consistent worldwide supply with a single product. Positive Phase 2 results served as the basis for the initiation of a Phase 3 study that is expected to enroll participants early 2025.
SP0230 is a pentavalent vaccine against meningitis caused by serogroups ABCWY in adults and adolescents. In 2024, a Phase 1/2 study enrolled the first participants; results are expected in the second half of 2025.
SP0237 is a flu mRNA vaccine that is part of the company’s efforts to develop a next generation, enhanced flu vaccine containing hemagglutinin and neuraminidase designed to offer improved efficacy and provide protection beyond flu. In 2024, a Phase 1/2 study with an enhanced mRNA formulation against flu enrolled the first participants.
SP0268, an acne mRNA vaccine designed for adolescents and adults with moderate to severe acne, is the most advanced therapeutic vaccine for acne in development. In 2024, a Phase 1/2 study evaluating SP0268 enrolled the first participants.
Two combination vaccine candidates for prevention of influenza and COVID-19 infections in individuals 50 years of age and older (SP0287), which were granted fast-track designation in the U.S., had their respective Phase 1/2 studies initiated in 2024. The first combination vaccine candidate consists of the influenza protein-based trivalent vaccine Fluzone HD combined with the adjuvanted recombinant Novavax COVID-19 vaccine. The second candidate combines the influenza recombinant protein-based trivalent vaccine Flublok with the Novavax COVID-19 vaccine.
Additional vaccine candidates entered clinical development with Phase 1/2 or Phase 2 clinical trials initiated in 2024, respectively for the prevention of pandemic flu (SP0289, a flu mRNA vaccine and SP0335, a flu H5 inactivated adjuvanted vaccine) and of RSV, hMPV, and parainfluenza virus type 3 (PIV3) infections in the older adult (SP0291, an RSV+hMPV+PIV3 mRNA vaccine).
Line extensions
The main R&D activities supporting line extensions for the company’s marketed products are summarized below.
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, jointly developed with Regeneron. Dupixent has received regulatory approvals in several countries for multiple indications. Details about clinical and regulatory activities for Dupixent during 2024 for the treatment of respiratory, dermatology and gastrointestinal diseases are provided below:
The FDA approved Dupixent as an add-on maintenance treatment of adults with COPD and an eosinophilic phenotype.
Dupixent is the first biologic medicine approved in the U.S. to treat these patients. The National Medical Products Administration in China approved Dupixent as an add-on maintenance treatment for adults with uncontrolled COPD characterized by raised blood eosinophils. Specifically, the approval covers patients already on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate. Dupixent has now been approved for the treatment of COPD in more than 30 countries worldwide, including the 27 countries in the EU. In Japan, approval is expected in the first half of 2025.
CSU is a chronic skin condition that causes sudden and debilitating hives and persistent itch, which can impact quality of life. LIBERTY-CUPID Study C, a confirmatory Phase 3 study, met the primary and key secondary endpoints for the treatment of patients with uncontrolled, biologic-naive CSU receiving background therapy with antihistamines. The new Study C data supported regulatory resubmission of the supplemental biologics license application (sBLA) for Dupixent in the U.S. in October 2024, with a target action date for the FDA decision of April 18, 2025. This positive study confirmed results from Study A, the first Phase 3 study of Dupixent in this setting. In early in 2024, Japan was the first country to approve Dupixent for adult and adolescent CSU patients based on the results from Study A. The indication is also under review in the EU based on results from Study A and Study B (patients uncontrolled on standard-of-care H1 antihistamines and refractory to omalizumab).
Dupixent’s pivotal LIBERTY-BP Phase 3 study in bullous pemphigoid (BP) met the primary and all key secondary endpoints evaluating its use in adults with moderate-to-severe disease. Dupixent had previously been granted orphan drug designation by the FDA for this chronic and relapsing disease, characterized by intense itch and blisters, reddening of the skin, and painful chronic lesions. The blisters and rash can form over much of the body and cause the skin to bleed and crust, resulting in patients being more prone to infection and affecting their daily functioning. Results of the LIBERTY-BP study served as the basis for the submission of the sBLA of Dupixent for the treatment of adults with moderate-to-severe BP.
The LIBERTY-CPUO-CHIC Study A Phase 3 study evaluating Dupixent in adults with uncontrolled and severe chronic pruritus of unknown origin (CPUO) did not achieve statistical significance in its primary itch responder endpoint (despite favorable numerical improvements) but showed nominally significant improvements in all other itch endpoints. The Dupixent Phase 3 study program in CPUO consists of Study A and Study B. Study B is intended to be initiated as a subsequent pivotal study.
A Regeneron-sponsored Phase 2/3 study evaluating Dupixent in adult and adolescent patients with eosinophilic gastritis with or without eosinophilic duodenitis is ongoing.
A Phase 3 program to evaluate Dupixent in adults with lichen simplex chronicus was initiated in 2024.
Finallly, a Phase 2 clinical study is ongoing for the treatment of patients with ulcerative colitis.
Kevzara, a monoclonal antibody against the IL-6 receptor developed with Regeneron, is already marketed for the treatment of moderate to severe rheumatoid arthritis and polymyalgia rheumatica.
In 2024, the FDA approved Kevzara for the treatment of patients weighing 63 kilograms or greater with active polyarticular juvenile idiopathic arthritis (pJIA), a form of arthritis that impacts multiple joints at a time. The approval in this patient population was supported by evidence from adequate and well-controlled studies and pharmacokinetic data from adults with rheumatoid arthritis as well as a pharmacokinetic, pharmacodynamic, dose finding and safety study in pediatric patients with pJIA. Approval in Europe for the treatment of patients with pJIA was obtained in January 2025.
Tzield, a CD3-directed monoclonal antibody, is the first and only disease modifying therapy in type 1 diabetes (T1D), a chronic autoimmune condition where the body’s ability to regulate blood sugar levels is impacted due to the gradual destruction of insulin producing beta cells by one’s own immune system. The product is approved by the FDA to delay the onset of Stage 3 T1D in adults and children eight years and older diagnosed with Stage 2 T1D. In addition, the potential of Tzield to slow the progression of Stage 3 T1D in newly diagnosed children and adolescents is being evaluated in a Phase 3 clinical program. In 2024, the EMA accepted for review the regulatory submission for Tzield in children and adolescents to delay the onset of stage 3 T1D, as well as for early intervention in stage 3 T1D.
Rezurock is a selective ROCK2 (rho-associated coiled-coil–containing protein kinase-2) inhibitor that was first approved by the FDA for the treatment of adult and pediatric patients aged 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy. Rezurock is now approved in multiple countries, including China, the UK and Canada. In 2024, the EMA accepted for review the regulatory submission of Rezurock for the third line treatment of chronic GVHD. The EMA granted an orphan designation in 2019 for this indication.
A Phase 3 study is evaluating Rezurock on top of azithromycin and standard-of-care regimen of immunosuppression in adult participants who have evidence of progressive chronic lung allograft dysfunction despite azithromycin therapy.
Nexviazyme is a long-term enzyme replacement therapy targeting the mannose-6-phosphate receptor to effectively clear glycogen build-up in muscle cells. This enzyme replacement therapy is approved for the treatment of patients with Pompe disease, a rare disease caused by a deficiency of the enzyme acid alpha-glucosidase (GAA). In Europe, the treatment is marketed under the brand name Nexviadyme.
In 2024, new data from the Mini-COMET Phase 2 long-term extension study in pediatric patients with infantile-onset Pompe disease (IOPD) suggested that Nexviazyme meaningfully improved ptosis, or drooping eyelid, over nearly three years. Additionally, positive safety debut data were obtained from the Baby-COMET Phase 3 study, the first study in over 20 years of any treatment in naive IOPD patients. This Phase 3 study is ongoing and is expected to read out in 2026.
Sarclisa is a monoclonal antibody designed to selectively bind to CD38, a cell surface antigen expressed in MM cancer cells and other hematological malignancies. Sarclisa is approved in several countries in combination settings for the treatment of adults with relapsed refractory multiple myeloma (RRMM). Sarclisa is under evaluation in combination with current standard and novel treatments across the MM treatment continuum.
Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as a first-line treatment option for adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant was approved by the FDA in September 2024 and in the EU and in China in January 2025. The regulatory submission in this indication for Sarclisa is under review in Japan, supported by the IMROZ Phase 3 study. This study demonstrated that Sarclisa in combination with standard-of-care VRd, followed by Sarclisa-Rd, improved progression-free survival (PFS) and led to a rapid and greater depth of response compared to VRd alone, as shown by minimal residual disease (MRD) negativity rate over time, in transplant- ineligible patients with newly diagnosed MM.
New results from the German-speaking Myeloma Multicenter Group (GMMG)-HD7 Phase 3 study showed that Sarclisa in combination with lenalidomide, bortezomib and dexamethasone (RVd) during induction therapy in NDMM, transplant-eligible, significantly prolonged PFS from first randomization, resulting in a statistically significant and clinically meaningful reduction in disease progression or death, compared to RVd induction regardless of the maintenance regimen. The study results supported the regulatory submission that is under review by the EMA.
The development of a new subcutaneous formulation of Sarclisa at a fixed dose in combination with pomalidomide and dexamethasone (Pd) in RRMM patients who have received at least one prior line of therapy is under evaluation in a Phase 3 study (IRAKLIA); in this program, Sarclisa is administered subcutaneously using Enable Injections’ enFuse hands-free on-body device delivery system. The co-primary endpoints of this study were met, supporting regulatory submissions in the U.S. and in the EU that are planned during the first half of 2025.
Sarclisa is also assessed in a Phase 3 study in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone in patients with high-risk smoldering MM, and in a Phase 2 study in new combinations with emerging novel mechanisms of action for the treatment of patients with RRMM or newly diagnosed MM patients.
Fluzone HD is a high-dose quadrivalent influenza vaccine licensed in the U.S. and in Europe for the elderly population, who do not respond as well to standard-dose influenza vaccines due to aging of the immune system (immuno-senescence). A Phase 3 study to evaluate immunogenicity and safety of Fluzone HD in participants 50 through 64 years of age was initiated in 2024.
MenQuadfi: Sanofi’s Men ACYW-TT vaccine is the company’s latest advance in meningococcal quadrivalent conjugate vaccination, designed to help protect an expanded patient group, including infants and adolescents through older adults. MenQuadfi is already licensed in the U.S. (for people aged two years and over), and in Europe and several other countries (for people aged 12 months and over).
MenQuadfi has also received WHO pre-qualification for people aged 12 months and above. In 2024, positive safety and immunogenicity results from a Phase 3 study of MenQuadfi to protect infants from six weeks of age against invasive meningococcal disease caused by serogroups ACWY, supported regulatory submission in the U.S. The FDA accepted for review the supplemental biologics license application for the potential extension of the indication to include children aged six weeks to 23 months through active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. The target action date for the FDA decision is May 23, 2025.
Marketing and Distribution
The company has business operations in approximately 63 countries and the company’s products are available in more than 160 countries.
The company’s main markets are the United States, Europe, and other countries.
Although specific distribution patterns vary by country, the company sells prescription drugs primarily to wholesale drug distributors, independent and chain retail drug outlets, hospitals, clinics, managed-care organizations and government institutions. Some products in Rare Diseases and Oncology may also be sold directly to physicians. With the exception of Opella products, the company’s drugs are ordinarily dispensed to patients by pharmacies upon presentation of a doctor’s prescription. The company’s vaccines are sold and distributed through multiple channels including physicians, pharmacies, hospitals, private companies and distributors in the private sector, and governmental entities and non-governmental organizations in the public and international donor markets.
The company uses a range of channels from in-person to digital to disseminate information about and promote the company’s products among healthcare professionals, ensuring that the channels not only cover the company’s latest therapeutic advances but also the company’s established prescription products, which satisfy patient needs in some therapy areas. In some countries, products are also marketed directly to patients by way of television, radio, newspapers and magazines, and digital channels (such as the internet), in accordance with local regulations. National education and prevention campaigns can be used to improve patients’ knowledge of their conditions. The company regularly exhibits at major medical congresses.
The company’s sales representatives, who work closely with healthcare professionals, use their expertise to promote and provide scientific information on the company’s drugs, and to inform healthcare professionals when necessary about alternative access to the company’s drugs for their patients. They represent the company’s values on a day-to-day basis and are required to adhere to a code of conduct and to internal policies on which they receive training.
Sanofi markets most of its products through its own sales forces.
Research and Development
In 2024, the company spent €7,394 million on research and development.
History
The company was founded in 1994. It was incorporated under the laws of France in 1994. The company was formerly known as Sanofi-Aventis and changed its name to Sanofi in 2011.
Sanofi Fragen und Antworten
Aus welchen Branchen kommen die Umsätze und welches sind die Top 3 Märkte?
Pharmazeutische Umsätze: ca. 70%
Impfstoffe: ca. 15%
Consumer Healthcare: ca. 15%
TOP 3 Märkte:
USA: ca. 35%
Europa: ca. 30%
China: ca. 10%
Sanofi generiert den Großteil seiner Umsätze aus dem pharmazeutischen Bereich, gefolgt von Impfstoffen und Consumer Healthcare-Produkten. Diese Diversifikation...
Pharmazeutische Umsätze: ca. 70%
Impfstoffe: ca. 15%
Consumer Healthcare: ca. 15%
TOP 3 Märkte:
USA: ca. 35%
Europa: ca. 30%
China: ca. 10%
Sanofi generiert den Großteil seiner Umsätze aus dem pharmazeutischen Bereich, gefolgt von Impfstoffen und Consumer Healthcare-Produkten. Diese Diversifikation ermöglicht es dem Unternehmen, auf unterschiedliche Marktanforderungen flexibel zu reagieren.
Die USA sind der größte Markt für Sanofi, was auf die hohe Nachfrage nach innovativen pharmazeutischen Produkten und Impfstoffen zurückzuführen ist. Europa folgt als zweitgrößter Markt, wobei hier ebenfalls ein starker Fokus auf pharmazeutische Produkte liegt. China stellt den drittgrößten Markt dar, mit wachsender Bedeutung durch die zunehmende Gesundheitsversorgung und steigende Nachfrage nach Medikamenten.
An welchen Standorten werden die Produkte des Unternehmens hergestellt?
Produktionsstandorte von Sanofi:
Sanofi betreibt weltweit über 70 Produktionsstätten in mehr als 30 Ländern.
Sanofi ist ein global agierendes Pharmaunternehmen mit einer Vielzahl von Produktionsstandorten weltweit. Die wichtigsten Produktionsstätten befinden sich in Europa, Nordamerika und Asien. In...
Produktionsstandorte von Sanofi:
Sanofi betreibt weltweit über 70 Produktionsstätten in mehr als 30 Ländern.
Sanofi ist ein global agierendes Pharmaunternehmen mit einer Vielzahl von Produktionsstandorten weltweit. Die wichtigsten Produktionsstätten befinden sich in Europa, Nordamerika und Asien. In Europa hat Sanofi bedeutende Produktionskapazitäten in Frankreich, Deutschland und Italien. In Nordamerika sind die USA ein zentraler Produktionsstandort. In Asien spielt Indien eine wichtige Rolle für die Produktion, insbesondere für Generika und Impfstoffe.
Diese globale Präsenz ermöglicht es Sanofi, effizient auf regionale Marktanforderungen zu reagieren und die Lieferketten zu optimieren. Die strategische Verteilung der Produktionsstätten unterstützt zudem die Forschung und Entwicklung neuer Produkte durch die Nähe zu wichtigen Märkten und Innovationszentren.
Welche Strategie verfolgt Sanofi für zukünftiges Wachstum?
Fokus auf Forschung und Entwicklung: 6,5 Milliarden Euro jährlich (2025)
Erweiterung im Bereich Impfstoffe und seltene Krankheiten: 20% Umsatzanteil (2025)
Digitalisierung und Automatisierung: Investitionen in Höhe von 1 Milliarde Euro (2025)
Sanofi verfolgt eine Wachstumsstrategie, die stark auf Fo...
Fokus auf Forschung und Entwicklung: 6,5 Milliarden Euro jährlich (2025) Erweiterung im Bereich Impfstoffe und seltene Krankheiten: 20% Umsatzanteil (2025) Digitalisierung und Automatisierung: Investitionen in Höhe von 1 Milliarde Euro (2025)
Sanofi verfolgt eine Wachstumsstrategie, die stark auf Forschung und Entwicklung (F&E) setzt. Das Unternehmen investiert jährlich etwa 6,5 Milliarden Euro in F&E, um seine Pipeline an innovativen Medikamenten zu erweitern. Ein besonderer Fokus liegt dabei auf der Entwicklung von Therapien für seltene Krankheiten und Impfstoffen, die mittlerweile rund 20% des Umsatzes ausmachen.
Darüber hinaus setzt Sanofi auf Digitalisierung und Automatisierung, um Effizienzgewinne zu erzielen und die Produktionskapazitäten zu erweitern. Hierfür sind Investitionen in Höhe von 1 Milliarde Euro vorgesehen, um moderne Technologien in den Produktionsprozessen zu integrieren.
Sanofi plant zudem, seine Marktpräsenz in aufstrebenden Märkten zu stärken und strategische Partnerschaften einzugehen, um den Zugang zu neuen Technologien und Märkten zu erleichtern. Diese Maßnahmen sollen dazu beitragen, das Wachstum des Unternehmens in den kommenden Jahren nachhaltig zu sichern.
Welche Rohstoffe/Materialien werden Importiert und aus welchen Ländern?
Hauptrohstoffe: Wirkstoffe, Hilfsstoffe, Verpackungsmaterialien
Herkunftsländer: China, Indien, USA, Deutschland
Sanofi importiert eine Vielzahl von Rohstoffen, die für die Herstellung ihrer pharmazeutischen Produkte notwendig sind. Zu den wichtigsten Materialien gehören pharmazeutische Wirkstoffe (...
Hauptrohstoffe: Wirkstoffe, Hilfsstoffe, Verpackungsmaterialien
Herkunftsländer: China, Indien, USA, Deutschland
Sanofi importiert eine Vielzahl von Rohstoffen, die für die Herstellung ihrer pharmazeutischen Produkte notwendig sind. Zu den wichtigsten Materialien gehören pharmazeutische Wirkstoffe (APIs), Hilfsstoffe und Verpackungsmaterialien.
China und Indien sind bedeutende Lieferanten für pharmazeutische Wirkstoffe und Hilfsstoffe, da diese Länder große Produktionskapazitäten und kostengünstige Herstellungsprozesse bieten. Die USA und Deutschland sind ebenfalls wichtige Partner, insbesondere für spezialisierte chemische Verbindungen und hochwertige Verpackungsmaterialien.
Die Diversifizierung der Lieferketten ist für Sanofi entscheidend, um die Versorgungssicherheit zu gewährleisten und auf geopolitische oder wirtschaftliche Veränderungen reagieren zu können.
Wie stark ist der Wettbewerbsvorteil des Unternehmens?
Marktanteil im Pharmasektor: 4,5% (2024)
Forschungs- und Entwicklungsinvestitionen: 6,2 Milliarden Euro (2024)
Sanofi hat einen signifikanten Wettbewerbsvorteil im Pharmasektor, der durch seine starke Marktposition und umfangreiche Investitionen in Forschung und Entwicklung gestützt wird. Mit einem...
Marktanteil im Pharmasektor: 4,5% (2024)
Forschungs- und Entwicklungsinvestitionen: 6,2 Milliarden Euro (2024)
Sanofi hat einen signifikanten Wettbewerbsvorteil im Pharmasektor, der durch seine starke Marktposition und umfangreiche Investitionen in Forschung und Entwicklung gestützt wird. Mit einem Marktanteil von 4,5% gehört Sanofi zu den führenden Unternehmen in der Branche.
Ein wesentlicher Faktor für den Wettbewerbsvorteil von Sanofi ist seine Fähigkeit, kontinuierlich in innovative Therapien und Medikamente zu investieren. Die Investitionen in Forschung und Entwicklung in Höhe von 6,2 Milliarden Euro im Jahr 2024 unterstreichen das Engagement des Unternehmens, neue Produkte zu entwickeln und bestehende zu verbessern.
Darüber hinaus profitiert Sanofi von einer breiten Produktpalette und einer globalen Präsenz, die es dem Unternehmen ermöglicht, von verschiedenen Märkten und Gesundheitstrends zu profitieren. Die strategische Ausrichtung auf Wachstumsbereiche wie Impfstoffe und seltene Krankheiten stärkt zusätzlich die Wettbewerbsposition von Sanofi.
Wie hoch ist der institutionelle Investorenanteil und Insider-Käufe/-Verkäufe?
Institutioneller Investorenanteil: ca. 70% (geschätzt 2025)
Insider-Käufe/-Verkäufe: Keine signifikanten Transaktionen im letzten Jahr (geschätzt 2025)
Der institutionelle Investorenanteil bei Sanofi liegt traditionell bei etwa 70%, was auf das Vertrauen großer Investmentfonds und institutioneller A...
Institutioneller Investorenanteil: ca. 70% (geschätzt 2025)
Insider-Käufe/-Verkäufe: Keine signifikanten Transaktionen im letzten Jahr (geschätzt 2025)
Der institutionelle Investorenanteil bei Sanofi liegt traditionell bei etwa 70%, was auf das Vertrauen großer Investmentfonds und institutioneller Anleger in die langfristige Stabilität und das Wachstumspotenzial des Unternehmens hinweist.
Im Jahr 2025 gab es keine bedeutenden Insider-Käufe oder -Verkäufe, was darauf hindeutet, dass das Management ein stabiles Vertrauen in die aktuelle Unternehmensstrategie und -performance hat. Solche Transaktionen können oft als Indikator für die Einschätzung der Unternehmensführung über die zukünftige Entwicklung des Unternehmens gesehen werden.
Wie viel Prozent Marktanteil hat Sanofi?
Marktanteil von Sanofi: 4,5% (2025, geschätzt im globalen Pharmamarkt)
Top Mitbewerber und Marktanteile:
Pfizer: 6,8% (2025)
Roche: 6,5% (2025)
Novartis: 6,2% (2025)
Johnson & Johnson: 5,9% (2025)
Merck & Co.: 5,0% (2025)
Sanofi: 4,5% (2025)
AstraZeneca: 4,2% (2025)
GlaxoSmithKline (GSK): 3...
Marktanteil von Sanofi: 4,5% (2025, geschätzt im globalen Pharmamarkt)
Top Mitbewerber und Marktanteile:
- Pfizer: 6,8% (2025)
- Roche: 6,5% (2025)
- Novartis: 6,2% (2025)
- Johnson & Johnson: 5,9% (2025)
- Merck & Co.: 5,0% (2025)
- Sanofi: 4,5% (2025)
- AstraZeneca: 4,2% (2025)
- GlaxoSmithKline (GSK): 3,8% (2025)
- AbbVie: 3,5% (2025)
- Bristol-Myers Squibb: 3,2% (2025)
Burggraben von Sanofi:
Sanofi verfügt über einen moderaten Burggraben, der hauptsächlich durch seine starke Position in der Impfstoffproduktion und der Forschung in seltenen Krankheiten gestützt wird. Ihre Pipeline an neuen Medikamenten und die strategische Fokussierung auf spezifische Therapiebereiche wie Immunologie und Onkologie tragen ebenfalls zu ihrem Wettbewerbsvorteil bei.
Im Vergleich zu den Mitbewerbern hat Sanofi jedoch einen weniger ausgeprägten Burggraben als Unternehmen wie Roche und Pfizer, die über eine stärkere Präsenz in der Onkologie und Biotechnologie verfügen. Diese Unternehmen profitieren von umfangreicheren Forschungs- und Entwicklungsbudgets und einer breiteren Produktpalette.
Sanofi muss weiterhin in Innovation und strategische Partnerschaften investieren, um seinen Burggraben zu stärken und sich gegen die Konkurrenz zu behaupten. Die kontinuierliche Anpassung an Markttrends und die Erschließung neuer Märkte sind entscheidend für die Aufrechterhaltung ihrer Wettbewerbsfähigkeit.
Ist die Sanofi-Aktie aktuell eine gute Investition?
Umsatzwachstum: 6,5% (2024)
Forschungs- und Entwicklungsaufwendungen: 6,2 Milliarden Euro (2024)
Marktanteil im Bereich Impfstoffe: 20% (2024)
Sanofi hat im Jahr 2024 ein Umsatzwachstum von 6,5% verzeichnet, was auf eine starke Performance in den Bereichen Impfstoffe und seltene Krankheiten zurückzu...
Umsatzwachstum: 6,5% (2024) Forschungs- und Entwicklungsaufwendungen: 6,2 Milliarden Euro (2024) Marktanteil im Bereich Impfstoffe: 20% (2024)
Sanofi hat im Jahr 2024 ein Umsatzwachstum von 6,5% verzeichnet, was auf eine starke Performance in den Bereichen Impfstoffe und seltene Krankheiten zurückzuführen ist. Das Unternehmen investiert weiterhin erheblich in Forschung und Entwicklung, mit Aufwendungen von 6,2 Milliarden Euro, um seine Produktpipeline zu stärken und innovative Therapien auf den Markt zu bringen.
Der Marktanteil von Sanofi im Bereich Impfstoffe liegt bei 20%, was die strategische Bedeutung dieses Segments unterstreicht. Die kontinuierlichen Investitionen in Forschung und Entwicklung könnten zu neuen Produktzulassungen führen, die das zukünftige Wachstum unterstützen.
Insgesamt zeigt Sanofi eine solide operative Leistung und eine starke Marktposition, insbesondere im Bereich der Impfstoffe. Diese Faktoren könnten das Unternehmen langfristig zu einer attraktiven Investition machen, insbesondere für Investoren, die auf Innovation und Marktführerschaft setzen.
Zahlt Sanofi eine Dividende — und wie zuverlässig ist die Ausschüttung?
Dividendenrendite: 3,5% (geschätzt für 2025)
Dividendenhistorie: Kontinuierliche Ausschüttung in den letzten 10 Jahren
Sanofi ist bekannt für seine zuverlässige Dividendenpolitik. Das Unternehmen hat in den letzten Jahren kontinuierlich Dividenden ausgeschüttet, was auf eine stabile finanzielle Basi...
Dividendenrendite: 3,5% (geschätzt für 2025)
Dividendenhistorie: Kontinuierliche Ausschüttung in den letzten 10 Jahren
Sanofi ist bekannt für seine zuverlässige Dividendenpolitik. Das Unternehmen hat in den letzten Jahren kontinuierlich Dividenden ausgeschüttet, was auf eine stabile finanzielle Basis und ein solides Geschäftsmodell hinweist.
Die Dividendenrendite von geschätzten 3,5% für 2025 spiegelt die Fähigkeit von Sanofi wider, seinen Aktionären regelmäßige Erträge zu bieten. Diese Zuverlässigkeit in der Ausschüttung ist typisch für große, etablierte Pharmaunternehmen, die über stabile Cashflows verfügen.
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