HUTCHMED (China) Expectations for 2026 | Price, Valuation & Forecast

HUTCHMED (China)

AIM:HCM

£ 2,17

£-0,01 (-0,46%)

2,17 £

£-0,01 (-0,46%)

End-of-day quote: 01/09/2026

HUTCHMED (China) Stock Value

The analyst rating for AIM:HCM is currently Outperform.

Outperform

HUTCHMED (China) Company Info

EPS Growth 5Y

17,61%

Market Cap

£1,87 B

Long-Term Debt

£0,05 B

Annual earnings

03/19/2026

Dividend

£0,00

Dividend Yield

0,00%

Founded

2000

Industry

Health Care

Country

Hong Kong

Website

HUTCHMED (China)

ISIN Number

KYG4672N1198

Website

http://www.hutch-med.com

Analyst Price Target

£3,41

57.14%

Last Update: 01/11/2026

Analysts: 7

Highest Price Target £5,46

Average Price Target £3,41

Lowest Price Target £2,04

In the last five quarters, HUTCHMED (China)’s Price Target has fallen from £4,62 to £3,72 - a -19,48% decrease. Four analysts predict that HUTCHMED (China)’s share price will increase in the coming year, reaching £3,41. This would represent an increase of 57,14%.

Top growth stocks in the health care sector (5Y.)

What does HUTCHMED (China) do?

HUTCHMED (China) Limited (HUTCHMED), a global commercial-stage biopharmaceutical company, focuses on the discovery, development and commercialization of targeted therapies and immunotherapies for the treatment of patients with cancer and immunological diseases. The company has developed fully integrated capabilities and expanded oncology and immunology drug development operations globally. The company has a pipeline of differentiated drug candidates covering both novel and validated targets, i...

The company has developed fully integrated capabilities and expanded oncology and immunology drug development operations globally.

The company has a pipeline of differentiated drug candidates covering both novel and validated targets, including MET, VEGFR, FGFR, CSF-1R, Syk, EZH2, PI3Kdelta, IDH, ERK, BTK, CD47, SHP2, and menin.

In China, three of the company’s internally developed drugs, savolitinib, fruquintinib, and surufatinib, are commercially available to patients as Orpathys, Elunate, and Sulanda, respectively. Outside of China, fruquintinib is marketed as Fruzaqla by the company’s partner Takeda and received approval in the U.S. in November 2023, in the E.U. in June 2024, in Switzerland and Argentina in August 2024, in Canada, Japan, and the United Kingdom in September 2024, in Australia and Singapore in October 2024, in Israel and the United Arab Emirates in December 2024, and in South Korea in March 2025. Regulatory applications are progressing in many other jurisdictions. To accelerate the availability of the company’s innovative medicines for patients globally, it seeks partnerships to commercialize its drugs outside of China, such as its partnership with AstraZeneca on savolitinib and with Takeda on fruquintinib.

Strategies

Key elements of the company’s strategy are to realize the global potential of its oncology drug candidates; continue designing and creating molecules to develop into medicines with specific and differentiated characteristics for the benefit of patients; establish a new in-house created platform with multiple potential IND candidates; build and scale its manufacturing and commercialization capabilities; identify China business development opportunities to complement its internal research and development activities; and capitalize on regulatory reforms underway in China aimed at addressing existing unmet medical needs and improving the health of its people.

Oncology Commercial Operations

Fruquintinib (Elunate in China, Fruzaqla outside China)

Fruquintinib was approved for 3L CRC in China in September 2018 and commercially launched in November 2018. There were close to 520,000 new CRC cases in China in 2022, and the incidence of 3L CRC was about 105,000. The second indication in China was conditionally approved in combination with Tyvyt for the treatment of 2L EMC with pMMR status. There were about 82,000 new EMC cases in China in 2020, with about 20% experiencing recurrence. The third potential indication of fruquintinib in China for 2L RCC is currently being investigated in a Phase II/III randomized, open-label, active-controlled study (FRUSICA-2). In China, fruquintinib was the leading treatment for late-stage CRC, with a 47% share of 3L treated patients according to an IQVIA tracking study in Q2 2024.

Fruquintinib is partnered with Eli Lilly under the brand of Elunate in China. HUTCHMED manages all on-the-ground medical detailing, promotion, and marketing activities in China. The company consolidates as revenue approximately 70-80% of Elunate in-market sales from manufacturing revenue, promotion and marketing services, and royalties paid to it by Lilly.

Fruquintinib is partnered with Takeda under the brand of Fruzaqla outside of China. Takeda launched Fruzaqla in the U.S. within 24 hours after it was approved by the FDA for 3L CRC on November 8, 2023, with the first prescription received a day after approval, followed by inclusion on November 16, 2023, in ‘NCCN Clinical Practice Guidelines for Colon Cancer’ and ‘NCCN Clinical Practice Guidelines for Rectal Cancer,’ which were updated as of February 7, 2025. Fruquintinib has also been successfully recommended in six other major treatment guidelines for colorectal cancer.

Fruzaqla received approval in the E.U. in June 2024, in Switzerland and Argentina in August 2024, in Canada, Japan, and the United Kingdom in September 2024, in Australia and Singapore in October 2024, in Israel and the United Arab Emirates in December 2024, and in South Korea in March 2025.

In January 2024, Elunate was approved in the Hong Kong Special Administrative Region.

Savolitinib (Orpathys in China)

Savolitinib was conditionally approved for 2L METex14 skipping NSCLC in China in June 2021, making it the first-in-class selective MET inhibitor in China. In January 2025, the company received NMPA full approval of 2L METex14 skipping NSCLC and expanded the label to include 1L METex14 skipping NSCLC.

The company is developing the next indication of savolitinib in combination with Tagrisso in 2L EGFRm NSCLC with MET amplification, currently under review by NMPA with Breakthrough Therapy designation and Priority Review Status. A similar combination Phase III study is underway globally by its partner AstraZeneca.

For savolitinib in combination with Tagrisso in 1L EGFRm NSCLC with MET overexpression, the company is enrolling patients in a China Phase III study (SAVNOVO). Savolitinib has also completed recruitment of a global Phase III study in MET-driven PRCC (SAMETA) and continues to enroll patients in a China Phase II registration-intent study in 3L GC with MET amplification.

In 2011, following the discovery and initial development of savolitinib by HUTCHMED, AstraZeneca and HUTCHMED entered a global licensing agreement to jointly develop and commercialize savolitinib. AstraZeneca is responsible for the commercialization of savolitinib in China and worldwide. The revenue generated from savolitinib consists of royalty revenue and manufacturing revenue of Orpathys, which the company sources from a third-party manufacturer and sells to AstraZeneca at cost.

Surufatinib (Sulanda in China)

Surufatinib was approved in China for non-pancreatic NETs in December 2020 and for pancreatic NETs in June 2021. It is being marketed by the company in China under the brand name Sulanda. There are approximately 34,000 new patients per year in China. According to the IQVIA tracking study report in the fourth quarter of 2023, Sulanda maintained its position in the market with a 21% prescription share in NET treatment, ahead of competitors Sutent and Afinitor. Surufatinib is also being investigated in a Phase II/III trial in a combination of surufatinib, camrelizumab (PD-1 antibody), nab-paclitaxel, and gemcitabine for 1L PDAC.

Surufatinib has been successfully recommended in the 2023 Chinese medical association consensus for standardized diagnosis and treatment of pancreatic cancer neuroendocrine neoplasms and four other treatment guidelines for neuroendocrine tumors. Following negotiations with the NHSA, Sulanda continues to be included in the NRDL starting in January 2024 at the same price as the 2022-23 NRDL price. The company currently owns all rights to surufatinib worldwide.

Tazemetostat (Tazverik in Hainan, Macau, and Hong Kong, China; the U.S. and Japan)

In August 2021, the company entered into a strategic collaboration with Epizyme, a subsidiary of Ipsen, to research, develop, manufacture, and commercialize tazemetostat in Greater China, including mainland China, Hong Kong, Macau, and Taiwan. The company is generally responsible for funding all clinical trials of tazemetostat in China, including the portion of global trials conducted there. Epizyme is eligible to receive, across up to eight potential indications, certain tiered royalties (from mid-teen to low-twenties percentage) based on annual net sales of tazemetostat in the licensed territory.

Tazemetostat received accelerated approval from the FDA based on ORR and DoR in January 2020 for epithelioid sarcoma and in June 2020 for r/r greater than or equal to2L EZH2m FL or r/r FL with no satisfactory alternatives. It is marketed by Ipsen in the U.S. and by Eisai in Japan.

In May 2022, Tazverik was approved by the Health Commission and Medical Products Administration of Hainan Province, China, to be used in the Hainan Boao Lecheng International Medical Tourism Pilot Zone (‘Hainan Pilot Zone’), under the Clinically Urgently Needed Imported Drugs scheme, for the treatment of certain patients with epithelioid sarcoma and follicular lymphoma consistent with the label as approved by the FDA. Launched in 2013, the Hainan Pilot Zone is a destination for international medical tourism and a global hub for scientific innovation, welcoming 83,900 medical tourists in 2020, according to official data. Tazemetostat is now included in four treatment guidelines and consensus recommendations: CSCO Guidelines for Lymphoid Malignancies, CSCO Guidelines for Bone and Soft Tissue Sarcoma, CACA Expert Consensus on Diagnosis and Treatment of Follicular Lymphoma in Elderly Patients in China, and CACA Guidelines for Diagnosis and Treatment of Follicular Lymphoma in China.

Ten epithelioid sarcoma patients began treatment in 2024 (2023: 16, 2022: 3). Tazverik was also approved in the Macau Special Administrative Region in March 2023 and Hong Kong Special Administrative Region in May 2024. In July 2024, the NDA for tazemetostat for the treatment of adult patients with 3L r/r EZH2m FL was accepted for review and granted Priority Review by the NMPA. The company is also taking part in the China portion of the global SYMPHONY-1 Phase III study of tazemetostat in combination with lenalidomide and rituximab in 2L FL. In-market shares and consolidated revenue were around 1.0 million each year for the last two years.

Discovery Research & the Antibody-Targeted Therapy Conjugate (ATTC) Technology Platform

The company has built a drug discovery engine based in China, which has already produced a pipeline of over 20 differentiated clinical and late pre-clinical stage drug candidates covering both novel and validated targets, of which three are now marketed. The company strives to create differentiated novel oncology and immunology treatments with global potential. These include small molecules and biologic therapies that address aberrant genetic drivers and cancer cell metabolism; modulate the tumor immune microenvironment; and target immune cell checkpoints. The company designs drug candidates to be used in combinations with other therapies, such as chemotherapy, immunotherapy, and other targeted therapies to attack disease simultaneously through multiple modalities and pathways.

In January 2025, the company announced its next-generation in-house technology platform in antibody-targeted therapy conjugates, or ATTCs. For over three years, it has invested significant resources into this new platform, which should provide multiple drug candidates in the future.

Pre-clinical data suggests robust anti-tumor activity, durable response with the company’s ATTC candidates when compared to monoclonal antibodies either alone and given in combination with targeted small molecule therapy in a variety of tumor types. IND-enabling work is ongoing, and the first global clinical trials, including in China, are expected to initiate in late 2025. Beyond these clinical stage candidates and ATTC candidates, the company continues to research and discover new types of drug candidates, including those that address cancer-related apoptosis, cell signaling, epigenetics, and protein translation, as well as other novel technologies. The following picture contrasts the difference between the traditional ADC and the pioneering ATTC.

Manufacturing

The company has established the FRUZAQLA supply chain for the global markets, including the U.S., E.U., and Japan. Two drug product sites for supplying fruquintinib to the U.S. market have been qualified: its own facility in Suzhou and a second site in Switzerland. Both sites have already successfully delivered commercial batches for product launches in several E.U. countries, the United Kingdom, and Switzerland during 2024.

The ATTC facility has commenced production of GMP-grade materials tailored for IND applications and clinical supply.

Other Ventures

The company’s Other Ventures include drug marketing and distribution platforms covering about 290 cities and towns in China, primarily focusing on prescription drugs through joint ventures. In December 2024, the company entered into agreements to dispose of a 45% equity interest in Shanghai Hutchison Pharmaceuticals to focus on its global innovative drug discovery and development businesses.

Shanghai Hutchison Pharmaceuticals’ main product is MUSKARDIA (also known as She Xiang Bao Xin or SXBX pill), an oral vasodilator prescription therapy for coronary artery disease and the largest botanical prescription drug in this indication in China.

Shanghai Hutchison Pharmaceuticals 45% Disposal: The company had been exploring opportunities to unlock the underlying value of Shanghai Hutchison Pharmaceuticals and focus resources on its global innovative drug discovery and development businesses. Subsequently, pursuant to the share purchase agreement, GP Health designated and the company entered into share purchase agreements with GP Zhicheng Private Equity and Shanghai Zhibaihe Enterprise Management to purchase a 25.1247% and a 9.8753% equity interest in Shanghai Hutchison Pharmaceuticals, respectively, together representing all of the GP Health Sale Shares. On March 14, 2025, the company dispatched to its shareholders a notice of Extraordinary General Meeting and circular to convene an Extraordinary General Meeting of its shareholders to approve the transactions on March 31, 2025.

Clinical Pipeline

Savolitinib (HMPL-504)

Savolitinib is a potent and selective inhibitor of MET, an enzyme that functions abnormally in many types of solid tumors. The company designed savolitinib to address human metabolite-related renal toxicity, the primary issue that halted the development of several other selective MET inhibitors. In clinical studies to date, savolitinib has shown promising signs of clinical efficacy in patients with MET gene alterations in NSCLC, PRCC, CRC, and GC with an acceptable safety profile. The company partners with AstraZeneca to develop and commercialize savolitinib globally.

Savolitinib Regulatory Status and Path

In June 2021, the NMPA conditionally approved savolitinib for 2L NSCLC with METex14 skipping alterations, making savolitinib the first-in-class selective MET inhibitor in China. This approval follows a priority review designation by the NMPA in July 2020.

In January 2025, the supplemental NDA for savolitinib was approved by the NMPA for 1L NSCLC with METex14 skipping alteration.

Savolitinib has been studied extensively in these patients in the TATTON and SAVANNAH studies, with results presented at WCLC 2021 and WCLC 2022, respectively. Findings based on the SAVANNAH and the TATTON studies supported the initiation of the SAFFRON global Phase III study as well as China Phase III studies, SACHI and SANOVO. In January 2023, savolitinib was granted Fast Track Designation by the FDA for the combination with Tagrisso in NSCLC patients with MET overexpression and/or amplification following progression on Tagrisso.

In October 2024, the company announced positive high-level results from the SAVANNAH Phase II trial that showed savolitinib plus Tagrisso demonstrated a high, clinically meaningful, and durable ORR for patients with EGFRm NSCLC with high levels of MET overexpression and/or amplification, whose disease progressed on treatment with Tagrisso. In December 2024, the NMPA granted Breakthrough Therapy Designation to the combination of savolitinib and Tagrisso for the treatment of patients with locally advanced or metastatic EGFR mutation-positive NSCLC with MET amplification after disease progression on EGFR inhibitor therapy.

Savolitinib Pre-clinical Evidence

In pre-clinical trials, savolitinib demonstrated strong in vitro activity against MET, affecting its downstream signaling targets and thus blocking related cellular functions effectively, including proliferation, migration, invasion, scattering, and the secretion of VEGF that plays a pivotal role in tumor angiogenesis. In the MET enzymatic assay, savolitinib showed potent activity with an IC50 of 5 nM. In a kinase selectivity screening with 274 kinases, savolitinib had potent activity against the MET Y1268T mutant (comparable to the wild-type), weaker activity against other MET mutants, and almost no activity against all other kinases. Savolitinib was found to be approximately 1,000 times more potent to MET than the next non-MET kinase. Similarly, in cell-based assays measuring activity against MET phosphorylation, savolitinib demonstrated potent activity in both ligand-independent (gene amplified) and ligand-dependent (overexpressed) cells with low IC50. In target-related tumor cell function assays, savolitinib showed high potency with IC50 of less than 10 nM. Savolitinib demonstrated cytotoxicity only on tumor cells that were MET amplified or overexpressed. In other cells, IC50 amounts were over 30,000 nM, thousands of times higher than the IC50 on MET tumor cells.

Savolitinib Clinical Development

In 2015, AstraZeneca received FDA approval for Tagrisso, its drug for the treatment of T790M+ EGFRm+, TKI-resistant NSCLC. A drug with this type of activity is known as a third-generation EGFR inhibitor. In 2018, Tagrisso’s label was expanded to include 1L metastatic EGFRm NSCLC. In December 2020, Tagrisso’s label was further expanded to include adjuvant therapy after tumor resection in EGFRm NSCLC. In February 2024, Tagrisso was approved in combination with chemotherapy for 1L EGFRm NSCLC. In September 2024, it was further approved for locally advanced unresectable (stage III) EGFRm NSCLC which has not progressed during or following chemoradiation. The company and AstraZeneca are studying savolitinib in combination with Tagrisso in both 1L and 2/3L settings which have developed a resistance to TKI (primarily Tagrisso).

2L EGFRm MET amplification/overexpression NSCLC

SAVANNAH: Phase II study of savolitinib with Tagrisso in 2/3L EGFRm NSCLC with MET amp/overexpression (NCT03778229)

SAVANNAH is a global Phase II single-arm study of savolitinib in combination with Tagrisso in 2/3L EGFRm NSCLC with MET amplification and/or overexpression upon disease progression following Tagrisso. The definition of MET overexpression was IHC 3+ in greater than or equal to50% of tumor cells (IHC50+) while MET amplification referred to FISH MET copy number greater than or equal to5 or MET:CEP7 ratio greater than or equal to2 (FISH5+). High cut-off levels for MET overexpression were defined as IHC 3+ in greater than or equal to90% (IHC90+) and MET amplification being copy number greater than or equal to10 (FISH10+). In addition to continuing Tagrisso 80mg OD, patients received savolitinib 300mg OD, 300mg BID, or 600mg OD.

SAFFRON: Phase III study of savolitinib with Tagrisso in 2/3L EGFRm NSCLC with MET amp/overexpression (NCT05261399)

SAFFRON is a global Phase III randomized, open-label, active-controlled study of savolitinib with Tagrisso in 2/3L EGFRm locally advanced or metastatic NSCLC patients with MET amplification and/or overexpression and progressed on 1L or 2L treatment with Tagrisso as the most recent therapy, with no prior chemotherapy in the metastatic setting allowed. Findings based on SAVANNAH and the TATTON studies supported the initiation of SAFFRON. Patients are prospectively selected for the higher level of MET aberration of FISH10+ and/or IHC90+. The SAFFRON study will evaluate the efficacy and safety of savolitinib in combination with Tagrisso compared to pemetrexed plus platinum doublet-chemotherapy, the current standard-of-care treatment in this setting. The primary endpoint of the study is PFS. The company’s partner AstraZeneca plans to recruit about 320 patients.

SACHI: Phase III study of savolitinib with Tagrisso in 2L EGFRm NSCLC with MET amplification (NCT05015608)

SACHI is a China Phase III open-label, randomized, controlled study on patients with locally advanced or metastatic EGFRm NSCLC with MET amplification after progression on first-, second-, or third-generation EGFR inhibitor therapy. The study will evaluate savolitinib 400mg or 600mg OD in combination with Tagrisso 80mg OD, compared to platinum-based doublet-chemotherapy (pemetrexed plus cisplatin or carboplatin), the standard of care treatment option in this setting. The primary endpoint of the study is PFS as assessed by investigators. In December 2024, the NMPA granted Breakthrough Therapy designation to this combination therapy. In a planned interim analysis, the IDMC considered that the study had met the pre-defined primary endpoint of PFS and enrollment into the study had concluded, leading to an acceptance of NDA with priority review status.

1L EGFRm MET amplification/overexpression NSCLC

SANOVO: Phase III study of savolitinib with Tagrisso in 1L EGFRm NSCLC with MET overexpression (NCT05009836)

SANOVO is a China Phase III randomized, double-blind, active-controlled study of savolitinib in combination with Tagrisso in 1L EGFRm NSCLC patients with MET overexpression. Patients with untreated unresectable or metastatic NSCLC carrying EGFR mutation (exon 19 deletion or L858R) and MET overexpression (IHC 2+ or 3+) are randomized into two groups: savolitinib 600mg or 400mg OD plus Tagrisso 80mg OD or placebo plus Tagrisso 80mg OD. The primary endpoint is PFS assessed by investigators. The first patient was dosed in September 2021. The company targets recruitment of 320 patients.

FLOWERS: Phase II study of savolitinib with Tagrisso in 1L EGFRm NSCLC with MET amp/overexpression (NCT05163249)

FLOWERS is a China Phase II randomized, investigator-initiated, prospective, multicenter study of savolitinib in combination with Tagrisso, versus Tagrisso alone, in 1L EGFRm NSCLC patients with MET amplification or overexpression. The definition of MET overexpression is IHC 3+ in greater than or equal to75% of tumor cells. The criteria of MET amplification are gene copy number greater than or equal to5 and/or MET/CEP7 ratio greater than or equal to2 by tissue FISH or MET GCNgreater than or equal to5 by tissue NGS. The primary endpoint is ORR. Interim results were presented at WCLC 2024. As of May 28, 2024, 44 patients were randomized into receiving a combination of savolitinib 300mg BID and Tagrisso 80mg OD (N=21) or Tagrisso monotherapy 80mg OD (N=23).

Monotherapy for 1/2L METex14 skipping NSCLC

Phase III study of savolitinib monotherapy in 1/2L METex14 NSCLC (NCT04923945)

The company completed a China Phase IIIb open-label, single-arm, multi-cohort confirmatory study of savolitinib in 1L or 2L METex14 skipping NSCLC patients. Preliminary data from the 1L cohort were presented during the WCLC 2023. At a data cut-off of April 30, 2023, among 84 patients, ORR was 60.7% and DCR was 95.2%. At a median follow-up of 11.1 months, PFS was 13.8 months.

Final data from the confirmatory Phase IIIb trial were presented at ELCC 2024. In 1L patients, ORR was 62.1%; DCR was 92.0% and DoR was 12.5 months, as assessed by an independent review committee. PFS was 13.7 months, and OS was not reached with a median follow-up of 20.8 months. In 2L patients, ORR was 39.2%; DCR was 92.4% and DoR was 11.1 months, as assessed by an independent review committee. PFS was 11.0 months, and OS was not mature with a median follow-up of 12.5 months. Responses occurred early (time to response 1.4-1.6 months) in both 1L and 2L patients. The safety profile was tolerable, and no new safety signals were observed. The most common Grade greater than or equal to3 TEAEs (5% or more of patients) were abnormal hepatic function (16.9%), increased alanine aminotransferase (14.5%), increased aspartate aminotransferase (12.0%), peripheral edema (6.0%), and increased gamma-glutamyltransferase (6.0%).

Phase II study of savolitinib in 2L METex14 NSCLC (NCT02897479)

The company completed a China Phase II open-label, single-arm, registration-enabling study of savolitinib in 2L METex14 skipping NSCLC patients who have progressed following prior systemic therapy or are unable to receive chemotherapy.

At ASCO 2020, the company presented interim data on 70 treated patients, of which 61 patients were efficacy evaluable at the data cut-off date of March 31, 2020. The overall data were encouraging, despite the inclusion of patients with a more aggressive subtype (36% with pulmonary sarcomatoid carcinoma) and showed tolerable safety. At a subsequent data cut-off date of August 3, 2020, in the 61 evaluable patients, ORR was 49.2%; DCR was 93.4% and DoR was 8.3 months. Results were published in The Lancet Respiratory Medicine and formed the basis for an NDA filing, which was approved by the NMPA in June 2021.

Savolitinib Combination - Kidney Cancer

SAMETA: Phase III study of savolitinib with Imfinzi PD-L1 inhibitor in MET-driven PRCC (NCT05043090)

SAMETA is a global Phase III randomized, open-label, active-controlled three-arm study of savolitinib in combination with Imfinzi in treatment-naïve patients with MET-driven, unresectable, and locally advanced or metastatic PRCC. Patients were randomized in a 2:1:1 ratio to receive 600 mg of savolitinib OD plus Imfinzi or Imfinzi monotherapy or Sutent monotherapy, an oral multi-kinase inhibitor considered as the standard of care treatment option in PRCC. The primary endpoint of the study is PFS. The first patient was dosed in October 2021. The company completed the enrollment of 140 patients in 2024.

Prior to SAMETA, the company conducted multiple global studies of savolitinib in PRCC patients, including the SAVOIR monotherapy and CALYPSO combination therapy trials, that both demonstrated highly encouraging results. The CALYPSO study was a global Phase II open-label investigator-initiated study of savolitinib in combination with Imfinzi in PRCC patients in the U.K. and Spain. A 24-month follow-up showed a median PFS of 15.7 months and median OS of 27.4 months in MET-driven PRCC patients. These results led to the initiation of a global Phase III SAMETA study in 2021.

Savolitinib - Gastric Cancer

Phase II study of savolitinib in 3L GC with MET amplification (NCT04923932)

MET-driven GC has a very poor prognosis. The company is carrying out a China Phase II two-stage, open-label, single-arm, multi-cohort registration-intent study of savolitinib for GC or gastroesophageal junction adenocarcinoma patients who progressed after at least one line of standard therapy. The primary endpoint is ORR as assessed by an independent review committee. The first patient was dosed in July 2021. Preliminary data from an interim analysis was reported at AACR 2023. Confirmed ORR was 45%, or 50% in the 16 patients with high MET gene copy number. The DoR rate at four months was 85.7%. The most common grade 3 or above TRAEs (more than 5%) were decreased platelet count, hypersensitivity, anemia, neutropenia, and abnormal hepatic function. The BID regimen is being investigated further in MET high patients. Following consultation with the NMPA, a ~60-patient registration cohort began enrolling in March 2023. In August 2023, the NMPA granted Breakthrough Therapy Designation for 3L gastric cancer with MET amplification.

Multiple Phase II studies have been conducted in Asia to study savolitinib in MET-driven GC, which accounts for approximately 5% of all GC patients, and demonstrated promising efficacy. The VIKTORY study is a biomarker-based, Phase II umbrella trial in GC conducted by the Samsung Medical Center in South Korea. Patients that tested positive for MET amplification or overexpression were treated with either savolitinib monotherapy or a combination of savolitinib and Taxotere. A total of 715 GC patients were successfully sequenced, and MET amplification was observed in 3.5% of these patients. Of the 10 associated clinical trials under the VIKTORY umbrella, the highest ORR was observed in the MET amplification arm in patients treated with savolitinib monotherapy, which reported an ORR of 50% and met pre-specified 6-week PFS rates. While the savolitinib and Taxotere combination was well tolerated, investigators decided to stop enrollment in the two combination cohorts in order to direct patients to the savolitinib monotherapy arm.

Savolitinib Commercial Launch

Sold under the brand name Orpathys, savolitinib was granted conditional approval in China by the NMPA for 2L NSCLC with METex14 skipping alterations and was launched in July 2021 by the company’s partner, AstraZeneca. In January 2025, the supplemental NDA for savolitinib was approved by the NMPA for 1L NSCLC with METex14 skipping alteration. The NMPA also converted the prior conditional approval in 2L patients to full approval. The new label indication included both treatment-naïve and previously treated patients in China.

Savolitinib Partnership with AstraZeneca

In December 2011, the company entered into a global licensing, co-development, and commercialization agreement for savolitinib with AstraZeneca. Based on savolitinib’s clinical progress as a highly selective MET inhibitor in a number of cancers, in August 2016, December 2020, and November 2021, the company and AstraZeneca amended its global licensing, co-development, and commercialization agreement for savolitinib.

Fruquintinib (HMPL-013)

Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor or VEGF receptors, known as VEGFR 1, 2, and 3. It has the potential to become a small molecule VEGFR 1, 2, and 3 inhibitor for many types of solid tumors that have the highest selectivity. The company designed fruquintinib to improve kinase selectivity to minimize off-target toxicities, improve tolerability, and provide more consistent target coverage. The tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction, suggests that it may be highly suitable for combinations with other anti-cancer therapies. The company has partnered with Eli Lilly on fruquintinib in China and Takeda outside of China.

Fruquintinib Regulatory Status and Path

For CRC, supported by data from the FRESCO China Phase III study, the NMPA accepted the company’s NDA submission for fruquintinib in June 2017. Fruquintinib was awarded priority review status by the NMPA in view of its clinical value in September 2017. In September 2018, fruquintinib was approved by the NMPA for the treatment of metastatic colorectal cancer patients who have failed at least two prior systemic antineoplastic therapies, including fluoropyrimidine, oxaliplatin, and irinotecan, with or without prior use of anti-VEGF or anti-EGFR therapies. It was launched in November 2018.

Building on the data collected from the FRESCO study, the company initiated the FRESCO-2 global Phase III study. Based on the successful results of FRESCO-2 and FRESCO, the FDA accepted the NDA submission and granted priority review status in May 2023, with a PDUFA date of November 30, 2023. On November 9, 2023, the FDA approved fruquintinib for adults with metastatic CRC who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy. Fruquintinib is the first and only selective inhibitor of all three VEGF receptor kinases approved in the U.S. for previously treated metastatic CRC regardless of biomarker status.

For EMC, the NMPA granted Breakthrough Therapy Designation to the combination of fruquintinib and Tyvyt in July 2023. Supported by data from the FRUSICA-1 China Phase II registrational study in 2L EMC patients with pMMR status, the NMPA accepted the NDA submission and granted priority review status in April 2024. Based on the study results, the NMPA granted conditional approval in December 2024 for the treatment of patients with advanced EMC with pMMR tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation.

Fruquintinib Pre-clinical Evidence

Pre-clinical trials have demonstrated that fruquintinib is a highly selective VEGFR 1, 2, and 3 inhibitor with high potency and low cell toxicity at the enzymatic and cellular levels. In a kinase selectivity screening, fruquintinib was found to be approximately 250 times more selective to VEGFR 3 than to the next non-VEGFR kinase.

Fruquintinib Clinical Development

Fruquintinib Monotherapy - Colorectal Cancer

FRESCO-2: Phase III study of fruquintinib in >3L CRC (NCT04322539)

FRESCO-2 is a global Phase III randomized, double-blind, placebo-controlled registration study of fruquintinib in CRC patients who had progression on or intolerance to Lonsurf and/or Stivarga; prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and, if RAS wild-type, an anti-EGFR therapy; and prior treatment with an immune checkpoint inhibitor or BRAF inhibitor if indicated.

Results were presented for the first time at ESMO 2022 and published in The Lancet. Between September 2020 and December 2021, the company recruited and randomized 691 patients 2:1 to receive fruquintinib 5mg OD (3 weeks on, 1 week off) or placebo. Both groups also received best supportive care. As of data cut-off of June 24, 2022, the median follow-up was 11.3 months.

A further analysis of data from the FRESCO and FRESCO-2 studies was presented at ASCO 2024. This analysis explored optimal sequencing of treatments in patients with metastatic colorectal cancer in the refractory setting. The magnitude of survival benefit with fruquintinib was similar irrespective of prior Lonsurf and/or Stivarga treatment status and sequence. In the FRESCO-2 study, prior therapies were balanced between fruquintinib versus placebo arms. Patients who had received prior Lonsurf reported PFS of 3.6 months in the fruquintinib arm vs. 1.9 months in the placebo arm. Patients who had prior Stivarga followed by Lonsurf showed PFS of 3.8 months in the fruquintinib arm vs. 1.8 months in the placebo arm. Patients who had prior Lonsurf followed by Stivarga experienced PFS of 3.7 months in the fruquintinib arm vs. 1.7 months in the placebo arm. Results also showed that the overall data of TEAEs with fruquintinib was consistent regardless of prior Lonsurf and/or Stivarga treatment status or sequence.

FRESCO: Phase III study of fruquintinib in 3L CRC (NCT02314819)

FRESCO is a China Phase III randomized, double-blind, placebo-controlled, pivotal study of fruquintinib in patients with locally advanced or metastatic CRC who had failed at least two prior systemic antineoplastic therapies, including fluoropyrimidine, Eloxatin, and Camptosar. At the time, no drug was approved for 3L CRC in China, with best supportive care being the general standard of care. This study followed a Phase II proof-of-concept trial in 3L CRC that met its primary endpoint of PFS. The company initiated the study in 2014 and completed enrollment in May 2016. The intent-to-treat population of 416 patients was randomized at a 2:1 ratio to receive 5 mg of fruquintinib orally OD, on a three-weeks-on/one-week-off cycle, plus best supportive care (278 patients) or placebo plus best supportive care (138 patients). The trial concluded in January 2017.

Fruquintinib had a manageable safety profile with lower off-target toxicities compared to Stivarga. CTC grade 3 or above hepatotoxicity was similar between the fruquintinib group and the placebo group. Stivarga showed markedly higher and often difficult to manage hepatotoxicity in the Chinese patient population in the CONCUR study, with adverse events leading to dose interruptions in 69% of patients, compared to 35% in the FRESCO study. The most frequent fruquintinib-related CTC grade 3 or above TEAEs included hypertension (21%), hand-foot skin reaction (11%), proteinuria (3%), and diarrhea (3%), all possibly associated with VEGFR inhibition. No other CTC grade 3 or above TEAEs exceeded 2% in the fruquintinib population. Dose interruptions or reductions occurred in only 35% and 24% of patients in the fruquintinib arm, respectively, and only 15% of patients discontinued treatment of fruquintinib due to adverse events versus 6% for placebo.

FRUSICA-1: Phase II study of fruquintinib in combination with Tyvyt 2L pMMR EMC (NCT03903705)

Platinum-based systemic chemotherapy is the standard first-line treatment for advanced endometrial cancer. However, patients who progress following first-line chemotherapy have limited treatment options, and the prognosis remains poor. FRUSICA-1 is a China Phase II open-label, single-arm registrational study of fruquintinib in combination with Tyvyt in 2L EMC patients with pMMR status. In July 2023, the study was fully enrolled and was granted Breakthrough Therapy Designation. Results were presented at ASCO 2024. As of November 15, 2023, 98 patients who had progressed on or were intolerable to up to two prior lines of platinum-based therapy were treated with fruquintinib 5mg OD (2 weeks on/1 week off) and Tyvyt 200mg Q3W. With a median follow-up of 7.9 months, PFS was 9.5 months per IRC assessment and 13.8 months for the subgroup with prior bevacizumab therapy (22 out of 98 patients). OS was not reached for the same subgroup after a follow-up of 15.7 months, but was 21.3 months for all patients.

FRUSICA-1 was preceded by a China Phase Ib/II basket study (same NCT03903705) evaluating the combination of fruquintinib and Tyvyt in a dose-escalation phase covering various solid tumors, followed by a dose-expansion phase on CRC, HCC, RCC, EMC, CC, NSCLC, and GC. For the EMC single-arm, multicenter dose expansion cohort, data was disclosed at CSCO 2021. As of the data cutoff date of August 31, 2021, 35 patients were enrolled. Of them, 29 were efficacy evaluable; 4 were treatment-naïve and 25 were pretreated. All 4 treatment-naïve patients experienced confirmed tumor response, for an ORR of 100%, and PFS was not reached.

FRUSICA-3: Phase III study of fruquintinib in combination with Tyvyt in 2L pMMR EMC (NCT06584032)

FRUSICA-3 is a China Phase III randomized, open-label, active-controlled confirmatory study of fruquintinib in combination with Tyvyt versus paclitaxel or doxorubicin for 2L EMC with pMMR. The primary endpoints are OS and PFS. The study enrolled its first patient in December 2024 and targets recruitment of about 400 patients.

FRUSICA-2: Phase II/III study of fruquintinib in combination with Tyvyt in 2L RCC (NCT05522231)

In first-line clear-cell renal cell carcinoma, clinical benefits have been demonstrated for the combination of antiangiogenic therapy and immunotherapy. However, there is limited evidence on the benefits of this combination in the second-line setting. FRUSICA-2 is a China Phase II/III randomized, open-label, active-controlled study in 2L advanced or metastatic RCC patients treated with fruquintinib in combination with Tyvyt versus axitinib or everolimus monotherapy. The trial started in October 2022 and completed recruitment of 234 patients in December 2023. The primary endpoint of PFS was met in March 2025, and the company is preparing an NDA submission to the NMPA.

FRUSICA-2 was preceded by a China Phase Ib/II basket study (NCT03903705) evaluating the combination of fruquintinib and Tyvyt in a dose-escalation phase covering various solid tumors, followed by a dose-expansion phase on CRC, HCC, RCC, EMC, CC, NSCLC, and GC. For the RCC open-label, single-arm, dose expansion cohort, data was presented at ASCO 2023 and published in Targeted Oncology in January 2025.

Phase Ib/II basket study of fruquintinib in combination with Tyvyt (NCT03903705)

The China Phase Ib/II basket study (NCT03903705) evaluated the combination of fruquintinib and Tyvyt in a dose-escalation phase covering various solid tumors, followed by a dose-expansion phase on CRC, HCC, RCC, EMC, CC, NSCLC, and GC.

For the GC Phase II single-arm cohort, 27 GC patients with PD-L1 status of CPSgreater than or equal to1 were enrolled between September 9, 2021, and July 31, 2023. Results were presented at ESMO 2023. 18 1L patients and 6 greater than or equal to2L patients were evaluable for efficacy, with PFS of 11.0 months and 10.5 months, respectively. OS was not mature while 15-month OS rates were 56.7% and 66.7%, for 1L and greater than or equal to2L patients, respectively.

For the NSCLC Phase II single-arm cohort, 13 NSCLC patients with PD-L1 expression TPS greater than or equal to1% were enrolled between October 2021 and September 8, 2023. Results were presented at ESMO Asia 2023. 12 1L patients were evaluable for efficacy, with PFS of 19.3 months and an 18-month OS rate of 61.5%, while median OS was not mature with a median duration of follow-up of 19.3 months. Confirmed ORRs were 50.0%; DCRs were 100.0% while DoR was not reached. There was no obvious difference in clinical responses between patients with 1%=CPS=49% and CPSgreater than or equal to50%. Grade greater than or equal to3 TRAE occurred in 69.2% of patients.

For the CC Phase II single-arm cohort, 34 CC patients were enrolled. Results were presented at ESMO Asia 2023 with a data cut-off date of May 30, 2023. There were 6 1L patients and 28 greater than or equal to2L patients; 8 with PD-L1 CPS<1 and 24 with CPSgreater than or equal to1; and 30 with pMMR status. PFS was 10.3 months and 8.2 months for 1L and greater than or equal to2L patients, respectively. OS was not reached yet with 15-month OS rates of 83.3% and 70.0% for 1L and greater than or equal to2L patients, respectively.

For the CRC Phase Ib/II dose-escalation plus dose-expansion cohorts, 44 CRC patients were enrolled between April 26, 2019, and December 30, 2021. Results were presented at ASCO 2021 and published in the European Journal of Cancer in March 2023. There were 30 2L patients and 13 greater than or equal to3L patients. 22 patients received fruquintinib 3mg OD + sintilimab Q3W while another 22 patients on 5mg OD 2 weeks on/1 week off, with the latter becoming the recommended dosing regimen. Among 43 efficacy evaluable patients, PFS was 5.6 months (6.9 months in the 5mg OD regimen); OS was 14.3 months (14.8 months in the 5mg regimen); ORR was 20.9% (23.8% in the 5mg OD regimen); DCR was 88.4% (100% in the 5mg OD regimen) and DoR was 8.3 months (9.7 months in the 5mg OD regimen). Within the 22 patients on the 5mg OD regimen, Grade greater than or equal to3 TRAEs occurred in 36.4% of patients, mainly hypertension (13.6%) and hand-foot syndrome (9.1%).

Fruquintinib Combination - Gastric Cancer

FRUTIGA: Phase III study of fruquintinib in combination with paclitaxel in 2L GC (NCT03223376)

FRUTIGA is a China Phase III randomized, double-blind active-controlled study of fruquintinib in combination with paclitaxel compared with paclitaxel monotherapy, for 2L GC. Enrollment was completed in July 2022. Its dual-primary endpoints were PFS and OS. The trial met the PFS endpoint at a statistically and clinically meaningful level. The OS endpoint was not statistically significant per the pre-specified statistical plan, although there was an improvement in median OS.

In April 2023, the NDA in China was accepted for review by the NMPA. In August 2024, the company voluntarily withdrew the supplemental NDA in China for fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric or gastroesophageal junction adenocarcinoma. Following an additional internal review of the current data package, in light of recent discussions with the NMPA, the company determined that the submission is unlikely to support an approval in China at this time.

Fruquintinib Exploratory Development

In China, the company supports an investigator-initiated trial program for fruquintinib, and there are about 100 of such trials ongoing in various solid tumor settings. A number of investigator-initiated trials were presented at ASCO 2023, AACR, ESMO 2023, and ASCO GI 2024, including initial results of a Phase II study of fruquintinib in combination with the investigator’s choice of chemotherapy in second-line metastatic CRC with microsatellite stable (MSS) phenotype, as well as fruquintinib monotherapy for the treatment of biliary tract cancer and soft tissue sarcoma.

Fruquintinib Partnership with Eli Lilly

In October 2013, the company entered into a license and collaboration agreement with Eli Lilly in China. In December 2018, the company amended its agreement, giving it, among other things, all planning, execution, and decision-making responsibilities for life cycle indication development of fruquintinib in China.

Fruquintinib Partnership with Takeda

In January 2023, the company entered into an agreement with a subsidiary of Takeda whereby it received an exclusive worldwide license from the company to develop, manufacture, and commercialize fruquintinib in all indications and territories outside of China.

Surufatinib (HMPL-012)

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFR and FGFR, both shown to be involved in tumor angiogenesis, and CSF-1R, which plays a key role in regulating tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be suitable for combinations with other immunotherapies. Surufatinib’s ability to inhibit angiogenesis, block the accumulation of tumor-associated macrophages, and promote the infiltration of effector T cells into tumors helps improve the anti-tumor activity of PD-1 antibodies. The company owns all rights to surufatinib globally.

Surufatinib Regulatory Status and Path

Surufatinib is being marketed by the company in China under the brand name Sulanda. It was approved by the NMPA in December 2020 for the treatment of non-pancreatic NETs and launched in mid-January 2021. This NMPA approval of surufatinib was based on results from the SANET-ep, a China Phase III study in patients with advanced non-pancreatic NETs. The positive results of this trial were highlighted in an oral presentation at ESMO 2019 and published in The Lancet Oncology in September 2020. In June 2021, surufatinib was approved by the NMPA for the treatment of advanced pancreatic NETs and launched in June 2021. This NMPA approval of surufatinib was based on results from the SANET-p, a China Phase III study in patients with advanced pancreatic NETs. The positive results of this trial were highlighted in an oral presentation at ESMO 2020 and published in The Lancet Oncology in September 2020. In 2022, the company presented a pooled analysis of safety data from the SANET-p and SANET-ep studies at ASCO 2022.

Surufatinib received FDA Fast Track Designations in April 2020 for the treatment of pNETs and epNETs. Orphan Drug Designation for pNETs was granted in November 2019. In a May 2020 pre-NDA meeting, the company reached an agreement with the FDA that the two positive Phase III studies of surufatinib in patients with pNETs and epNETs in China, along with the bridging trial in the U.S., could form the basis to support a U.S. NDA submission. The FDA accepted the filing of the NDA in June 2021. However, in April 2022, the company received a Complete Response Letter from the FDA regarding the NDA for surufatinib for the treatment of pNETs and epNETs. Based on interactions with the FDA and EMA, a new multi-regional clinical trial would be required to move forward with this program in the U.S. and Europe. Following dialogue with the PMDA, the company has decided not to file a Japanese NDA on the basis of the clinical trial data available at this time.

Surufatinib Pre-clinical Evidence

Surufatinib inhibited VEGFR 1, 2, and 3, FGFR1, and CSF-1R kinases with IC50 in a range of 1 nM to 24 nM. It blocked VEGF-induced VEGFR2 phosphorylation in HEK293 cells and CSF-1R phosphorylation in RAW264.7 cells with an IC50 of 2 nM and 79 nM, respectively. Surufatinib also reduced VEGF- or FGF-stimulated human umbilical vein endothelial cell proliferation with an IC50 < 50 nM. In animal studies, a single oral dose of surufatinib inhibited VEGF-stimulated VEGFR2 phosphorylation in the lung tissues of nude mice in an exposure-dependent manner. Elevation of FGF23 levels in plasma 24 hours post-dosing suggested suppression of FGFR signaling. Surufatinib demonstrated potent tumor growth inhibition in multiple human xenograft models and decreased cluster of differentiation 31 expression remarkably, suggesting strong inhibition of angiogenesis through VEGFR and FGFR signaling.

In a syngeneic murine colon cancer model, surufatinib demonstrated moderate tumor growth inhibition after single-agent treatment. Flow cytometry and immunohistochemistry analysis revealed an increase of certain T cells and a significant reduction in certain tumor-associated macrophages, including CSF-1R mutation-positive tumor-associated macrophages in tumor tissue, indicating surufatinib has a strong effect on CSF-1R. A combination of surufatinib with a PD-L1 antibody resulted in enhanced anti-tumor effect. These results suggested that surufatinib has a strong effect in modulating angiogenesis and cancer immunity.

Surufatinib Clinical Development

Surufatinib Combination – Pancreatic Cancer

Phase II/III study of surufatinib in combination with Airuika and chemotherapy in 1L PDAC (NCT06361888)

The company started a China Phase II/III multicenter, randomized, open-label, active-controlled study in adults with metastatic pancreatic cancer who have not been previously treated with a systemic anti-tumor therapy evaluating the use of surufatinib combined with camrelizumab (an anti-PD-1), nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine. After an initial safety run-in stage, the Phase II/III stage may enroll a further 500 patients, with a primary endpoint of OS. The Phase II stage of 62 patients was fully enrolled in November 2024.

This study was informed in part by an investigator-initiated trial presented at ASCO GI 2024 (NCT05218889) using surufatinib combined with camrelizumab plus chemotherapy as 1L therapy for pancreatic adenocarcinoma. Median PFS and OS were 9.0 and 13.3 months, respectively, compared to 5.8 and 8.6 months in the control group with chemotherapy only.

Surufatinib Monotherapy - Neuroendocrine Tumors

SANET-ep study: Phase III study of surufatinib in non-pancreatic NETs (NCT02588170)

SANET-ep is a China Phase III randomized, double-blind, placebo-controlled study of surufatinib in patients with unresectable or metastatic, well-differentiated, extrapancreatic NETs and progression on no more than two types of previous systemic regimens. The primary endpoint was PFS. Patients were randomized in a 2:1 ratio to receive either 300 mg of surufatinib OD or a placebo OD on a 28-day treatment cycle. Between December 9, 2015, and March 31, 2019, the company enrolled 198 patients. An interim analysis was conducted in mid-2019, meeting predefined criteria for early discontinuation and leading to IDMC’s recommendation to stop the trial early, with the results presented at ESMO 2019, and published in The Lancet Oncology in September 2020.

SANET-p study: Phase III study of surufatinib in pancreatic NETs (NCT02589821)

SANET-p is a China Phase III randomized, double-blind, placebo-controlled study of surufatinib in patients with progressive, advanced, well-differentiated pancreatic NETs and progression on no more than two types of previous systemic regimens. The primary endpoint was PFS. Patients were randomized at a 2:1 ratio to receive either 300 mg of surufatinib OD or a placebo OD on a 28-day treatment cycle. Between February 18, 2016, and November 11, 2019, the company enrolled 172 patients. An interim analysis was conducted in early 2020, meeting predefined criteria for early discontinuation and leading to IDMC’s recommendation to stop the trial early, with the results presented and published in The Lancet Oncology in September 2020.

Sovleplenib (HMPL-523)

Sovleplenib is a novel, selective, oral inhibitor targeting Syk, for the treatment of hematological malignancies and immune diseases. Syk is a component in the Fc receptor and B-cell receptor signaling pathway. The threshold of safety for a Syk inhibitor in chronic disease is extremely high, with no room for material toxicity. The failure of Tavalisse in a global Phase III registration study in rheumatoid arthritis provided important insights for the company in the area of toxicity. In addition, Tavalisse has also been shown to strongly inhibit the Ret kinase, and in pre-clinical trials, it was demonstrated that inhibition of the Ret kinase was associated with developmental and reproductive toxicities. The company owns all rights to sovleplenib globally.

Sovleplenib Regulatory Status and Path

The company submitted the NDA for sovleplenib for the treatment of adult patients with primary immune thrombocytopenia (‘ITP’), and it was accepted by the NMPA in January 2024 with priority review status. This NDA is supported by data from ESLIM-01, a China Phase III randomized, double-blinded, placebo-controlled study of sovleplenib in 188 adult patients with primary ITP who have received at least one prior line of standard therapy. In January 2022, sovleplenib received Breakthrough Therapy Designation in China for the treatment of primary ITP. In 2024, the company started a Phase I/Ib dose-optimization study overseas (NCT06291415).

Besides the clinical trials related to primary ITP, the company also has various clinical trials of sovleplenib ongoing. In September 2022, the company initiated ESLIM-02, a China Phase II/III randomized, double-blind, placebo-controlled study of sovleplenib in the treatment of wAIHA. The enrollment of the Phase II part of the study was completed in mid-2023, and the primary endpoint has been met. The company initiated the Phase III phase in March 2024 in China.

Sovleplenib Pre-clinical Evidence

The safety profile of sovleplenib was evaluated in multiple in vitro and in vivo pre-clinical trials under good laboratory practice guidelines and found to be well tolerated following single-dose oral administration. It is a highly selective Syk inhibitor with an IC50 of 24 ± 4 nM in a Syk kinase enzymatic assay. Sovleplenib’s lack of KDR inhibition means a much lower risk of hypertension, a major off-target toxicity in clinical trials. Sovleplenib was evaluated in collagen-induced rheumatoid arthritis in mice and rats, and it significantly reduced disease severity in a dose-dependent manner; stopping disease progression and reversing paw swelling and bone resorption to normal levels. In lupus-prone mice, sovleplenib significantly blocked skin lesions, delaying the onset of proteinuria, reducing the immune organs to body weight ratios, and suppressing the production of anti-nuclear antibodies.

Sovleplenib Clinical Development

Sovleplenib Monotherapy - ITP

ESLIM-01: Phase III study of sovleplenib in ITP (NCT05029635)

ESLIM-01 is a China Phase III randomized, double-blinded, placebo-controlled study in patients with primary ITP who have received at least one prior line of standard therapy. Between September 29, 2021, and December 31, 2022, 188 patients were 2:1 randomized to receive sovleplenib 300 mg OD or placebo for 24 weeks. The primary endpoint is durable response rate. In January 2022, the NMPA granted Breakthrough Therapy Designation for this indication. All endpoints were met in August 2023. In June 2024, the company presented the results at EHA 2024 and published them in The Lancet Haematology. Long-term follow-up analysis was presented at ASH 2024. The NDA is under review by the NMPA. Additional data were requested by CDE and subsequently submitted by HUTCHMED. The supplementary data is currently under review by CDE.

A follow-on, open-label sub-study of the extension stage of ESLIM-01 Phase III demonstrated long-term benefits in increasing and maintaining platelet count. The data was presented at ASH 2024. In the overall population, the overall response was achieved by 81% (145/179) of the patients, with a durable response rate of 51.4% and long-term durable response rate of 59.8%.

ESLIM-01 is supported by the results of a randomized, double-blind, and placebo-controlled Phase Ib study in ITP presented at ASH 2021. As of the data cut-off date of September 30, 2021, a total of 34 patients were randomized to receive sovleplenib and 11 patients to placebo. Among 16 patients who were randomized to receive the RP2D of 300mg OD, 68.8% experienced a response as defined by at least one incident of platelet count being greater than or equal to 50×109/L in the initial 8-week double-blinded phase of the study.

Sovleplenib Monotherapy - wAIHA

ESLIM-02: Phase II/III study of sovleplenib for wAIHA (NCT05535933)

ESLIM-02 is a China Phase II/III randomized, double-blind, placebo-controlled study in adult patients with primary or secondary AIHA who had relapsed or were refractory to at least one prior line of standard treatment. AIHA is an autoimmune disorder resulting in a shortened red blood cell (‘RBC’) lifespan and increased RBC clearance. Incidence ranges from 0.8 to 3.0 per 100,000/year globally, with a prevalence of 17 per 100,000. Mortality rates are 8–11% and up to 30% in severe cases involving critically ill patients. wAIHA is the most common form of AIHA and accounts for 70–80% of cases.

Between September 26, 2022, and May 9, 2023, 21 patients were enrolled in the Phase II part of the study and were randomized 3:1 to receive sovleplenib 300mg OD or placebo. Results were presented at EHA 2024 and published in The Lancet Haematology in February 2025.

In March 2024, the company initiated the registration stage of the Phase II/III clinical trial (same NCT05535933) of sovleplenib in adult patients with wAIHA in China.

Tazemetostat

Tazemetostat is an inhibitor of EZH2 developed by Ipsen. It received accelerated approval from the FDA based on ORR and DoR in January 2020 for epithelioid sarcoma and in June 2020 for r/r greater than or equal to2L EZH2m FL or r/r FL with no satisfactory alternatives.

In August 2021, the company entered into a strategic collaboration with Epizyme, a subsidiary of Ipsen, to research, develop, manufacture, and commercialize tazemetostat in Greater China, including mainland China, Hong Kong, Macau, and Taiwan. The company is generally responsible for funding all clinical trials of tazemetostat in China, including the portion of global trials conducted there. Separately, the company is conducting a China bridging study in follicular lymphoma for potential conditional registration based on its U.S. approvals. The study is fully enrolled. The company is responsible for the research, manufacture, and commercialization of tazemetostat in China.

In May 2022, it was approved by the Health Commission and Medical Products Administration of Hainan Province, China, to be used in the Hainan Boao Lecheng International Medical Tourism Pilot Zone, under the Clinically Urgently Needed Imported Drugs scheme, for the treatment of certain patients with epithelioid sarcoma and follicular lymphoma consistent with the label as approved by the FDA. Tazemetostat was launched in 2013, and the Hainan Pilot Zone is a destination for international medical tourism and a global hub for scientific innovation, welcoming 83,900 medical tourists in 2020, according to official data. Tazemetostat is now included in four treatment guidelines and consensus recommendations: CSCO Guidelines for Lymphoid Malignancies, CSCO Guidelines for Bone and Soft Tissue Sarcoma, CACA Expert Consensus on Diagnosis and Treatment of Follicular Lymphoma in Elderly Patients in China, and CACA Guidelines for Diagnosis and Treatment of Follicular Lymphoma in China.

Ten epithelioid sarcoma patients began treatment in 2024 (2023: 16, 2022: 3). Tazverik was also approved in the Macau Special Administrative Region in March 2023 and Hong Kong Special Administrative Region in May 2024. In July 2024, the NDA was accepted by NMPA with Priority Review for r/r greater than or equal to2L EZH2m FL.

The company is developing and plans to seek approval for tazemetostat in various hematological and solid tumors in China. It is participating in Ipsen’s SYMPHONY-1 (EZH-302) study, leading it in China.

Tazemetostat Clinical Development

Phase II bridging study of tazemetostat in r/r greater than or equal to3L FL (NCT05467943)

In July 2022, the company initiated a China Phase II open-label, two-cohort bridging study of tazemetostat in r/r greater than or equal to3L FL intended to support conditional registration in China. Patients received 800mg of tazemetostat BID. The primary objective is to evaluate ORR in patients with EZH2m (Cohort 1). The secondary objectives are to evaluate DoR, PFS, and OS in patients with EZH2m and EZH2w (Cohort 2). Enrollment was completed with 42 patients in September 2023. In July 2024, the NDA was accepted by NMPA with Priority Review for r/r greater than or equal to2L EZH2m FL.

SYMPHONY-1: Phase Ib/III study of tazemetostat in combination with lenalidomide and rituximab for r/r greater than or equal to2L EZH2w/EZH2m FL (NCT04224493)

SYMPHONY-1 (EZH-302) is a global Phase Ib/III randomized, double-blind, active-controlled, three-stage study of tazemetostat in combination with R² (lenalidomide and rituximab) in r/r greater than or equal to2L EZH2w/EZH2m FL. Ipsen conducted the Phase Ib portion of the study in 2021. Results of the Phase Ib open-label portion were presented in ASH 2022 and ASH 2023. As of July 10, 2023, 44 patients were treated with 400 mg, 600 mg, or 800 mg of tazemetostat BID, with 31.8% of patients receiving >1 prior therapy and 81.8% being EZH2w. RP3D was determined as 800mg BID. ORRs were 88.9% in EZH2w and 100% in EZH2m. PFS and DoR were not reached after a follow-up of 22.5 months. There were no dose-limiting toxicities, with the most common Grade 3-4 TEAE being neutropenia (40.9%), while TEAE leading to discontinuation was 20.5%. The safety profile was consistent with previously reported safety information for both tazemetostat and R².

In the Phase III portion of the randomized, double-blind, active-controlled study, approximately 560 patients are randomized 1:1 to receive tazemetostat with R² or placebo with R². The study also includes a maintenance arm with tazemetostat or placebo following the first year of treatment. The primary endpoint is PFS as assessed by the investigator. The first patient was enrolled in May 2022, and the first China patient was enrolled in September 2022.

Fanregratinib (HMPL-453)

Fanregratinib is a novel, selective, oral inhibitor targeting FGFR 1/2/3. Aberrant FGFR signaling is associated with tumor growth, promotion of angiogenesis, as well as resistance to anti-tumor therapies. Approximately 10-15% of IHCC patients have tumors harboring FGFR2 fusion. The company retains all rights to fanregratinib worldwide.

Fanregratinib Pre-clinical Evidence

Preclinical data of fanregratinib was presented at AACR 2023. Fanregratinib potently inhibited the tyrosine kinase activities of recombinant FGFR 1, 2, and 3 in vitro (IC50 values of 6, 4, and 6 nM, respectively) with weaker activity against FGFR4 (IC50 = 425 nM). It selectively inhibited the proliferation of tumor cell lines with dysregulated FGFR signaling (GI50: 3~105 nM) compared with cell lines lacking FGFR aberrations (GI50: > 1.5 µM). Oral administration could induce time- and dose-dependent inhibition of phosphorylation of FGFR and resulted in remarkable and dose-dependent anti-tumor activity in multiple FGFR-altered tumor models. Fanregratinib at a dose of 50 mg/kg/day could induce tumor regression in most tumor models tested. It significantly improved the anti-tumor activity of the anti-PD-1 antibody in a FGFR2 fusion model by priming the immune environment. Fanregratinib has good pharmacokinetic properties characterized by rapid absorption following oral dosing, good bioavailability, moderate tissue distribution, and moderate clearance in all pre-clinical animal species. Fanregratinib was found to have little inhibitory effect on major cytochrome P450 enzymes, indicating a low likelihood of drug-to-drug interaction issues.

Fanregratinib Clinical Development

Phase II study of fanregratinib in 2L IHCC with FGFR2 fusion (NCT04353375)

The registration phase of an ongoing China Phase II open-label, single-arm study of fanregratinib in 2L IHCC with FGFR2 fusion started after the company consulted with NMPA in 2023. If positive, the data may be used to support a future NDA filing. The company dosed the first patient in March 2023 and completed recruitment of 87 patients in March 2025.

Phase Ib/II study of fanregratinib in combination with chemotherapies or toripalimab in solid tumors (NCT05173142)

A China Phase Ib/II open-label, two-stage study started in 2022 to evaluate the use of fanregratinib in combination with chemotherapy (gemcitabine and cisplatin) or Tuoyi (PD-1) in patients with specific advanced or metastatic solid tumors. The first stage of the study is a dose escalation phase to determine DLT and RP2D. The second stage is a dose expansion phase in solid tumor patients with either GC, IHCC, or urothelial carcinoma harboring specific FGFR gene alterations.

Ranosidenib (HMPL-306)

Ranosidenib is a novel dual-inhibitor of IDH1 and IDH2 enzymes. IDH1 and IDH2 mutations have been implicated as drivers of certain hematological malignancies, gliomas, and solid tumors, particularly among acute myeloid leukemia patients, with approximately 20% of patients having mutant IDH genes. IDH mutations also occur in myelodysplastic syndrome (‘MDS’), myeloproliferative neoplasms (‘MPNs’), low-grade glioma, and intrahepatic cholangiocarcinoma. The company retains all rights to ranosidenib worldwide.

Ranosidenib Clinical Development

RAPHAEL: Phase III study of ranosidenib in r/r mIDH1/2 AML (NCT06387069)

RAPHAEL is a China Phase III randomized, open-label, active-controlled, registrational study of ranosidenib in r/r AML harboring IDH1 and/or IDH2 mutations. Patients will either receive ranosidenib 250 mg OD during the first 28-day cycle and then 150 mg OD starting from the second cycle, or salvage chemotherapy, such as MEC (etoposide, cytarabine, mitoxantrone) or FLAG ± Ida (G-CSF, fludarabine, cytarabine, idarubicin) or cytarabine or azacitidine. The primary endpoint is OS, with secondary endpoints including CR rate, CR+CRh rate, CR+Cri+CRh rate, EFS, DoR, TTR, safety, and QoL. The study dosed the first patient on May 11, 2024, and targets recruitment of about 320 patients.

Phase I study of ranosidenib in r/r mIDH1/2 myeloid hematological malignancies (NCT04272957)

A China Phase I open-label, two-phase study of ranosidenib in r/r myeloid hematological malignancies (AML, MDS, CMML, MPN) harboring IDH1 and/or IDH2 mutations started in July 2021. Results of the dose escalation phase were presented at EHA 2023. At the data cut-off date of April 20, 2023, 51 patients were enrolled with a median follow-up of 7.4 months. ORR was 33.3%, and CR+Cri+CRMRD- was 31.4%. For two cohorts of 150 mg OD and 250mg OD with 34 patients combined, the overall ORR was 44.1%, while IDH1 and IDH2 subgroups reported ORRs of 42.9% and 45.0%, respectively, as well as ORRs of 38.9% and 50.0% in BCL2i naïve and BLC2i pretreated subgroups, respectively.

HMPL-760

HMPL-760 is an investigational, non-covalent, third-generation BTK inhibitor. It is a highly potent, selective, and reversible inhibitor with long target engagement against BTK, including wild-type and C481S-mutated BTK. The company retains all rights to HMPL-760 worldwide.

HMPL-760 Pre-clinical Evidence

Pre-clinical data was presented at AACR 2023 showing HMPL-760 as a reversible, selective, highly potent BTK inhibitor targeting both wild-type and C481 mutated BTK. In the reversibility study, it showed full recovery, as compared to no recovery for another BTK inhibitor. HMPL-760 demonstrated stronger inhibition of BTK phosphorylation, B-NHL cell growth, and whole blood B-cell activation; maintained a longer duration; and exhibited stronger anti-tumor efficacy in xenograft models than other BTK inhibitors tested in the same study.

HMPL-760 Clinical Development

Phase II study of HMPL-760 in patients with r/r DLBCL (NCT06601504)

In November 2024, the company started a China Phase II randomized, active-controlled study of HMPL-760 in combination with R-GemOx versus placebo in combination with R-GemOx in patients with r/r DLBCL.

Phase I study of HMPL-760 in patients with r/r lymphomas (NCT05190068)

In this dose escalation phase, patients with r/r lymphoma that failed standard therapy were eligible. Data was presented at EHA Congress in June 2024. As of September 30, 2023, a total of 26 patients with r/r lymphoma (10 CLL/SLL, 4 MCL, 7 DLBCL, 2 LPL/WM, 2 FL, 1 MZL) were treated. The median number of prior therapies was 2, of which 8 patients had prior exposure to BTK inhibitors. The most common (greater than or equal to30%) TRAEs were neutrophil count decrease, platelet count decrease, and anemia. Most of the TRAEs were concentrated in grade 1-2. Only 2 patients (600 mg) experienced drug-related serious adverse events (pulmonary tuberculosis, drug-induced liver injury). 26 patients had post-baseline tumor assessments and achieved an ORR of 73.1%. The median TTR was 2.3 months. Among 8 patients treated with BTK inhibitors, the ORR was 87.5%. 400 mg OD was selected as RP2D.

HMPL-506

HMPL-506 is a novel, investigational, selective small molecule inhibitor for oral administration targeting the menin protein. The menin protein is a scaffold protein that controls gene expression and cell signaling. Revumenib is the only FDA-approved menin inhibitor, and currently, there are no menin inhibitors approved in China. The company retains all rights to HMPL-506 worldwide.

HMPL-506 Pre-clinical Evidence

Pre-clinical data was presented at AACR 2024 highlighting HMPL-506 as a novel and highly differentiated menin-MLL inhibitor with robust anti-tumor activities, favorable ADME properties, and low risk of cardiac toxicity. Compared with the other 5 menin inhibitors in clinical stages, HMPL-506 showed the strongest inhibitory potency in MLL-r and NPM1m cell line models. Treatment at 10 mg/kg and 25 mg/kg resulted in tumor shrinkage in all treated animals, with tumor regression rates of 72% and 100%, respectively. HMPL-506 synergistically improved the anti-tumor effect of azacytidine, venetoclax, and gilteritinib against MLL-r leukemias. HMPL-506 displayed favorable PK profiles and high selectivity among multiple kinases, methyltransferases, and safety-related targets. The IC50 of HMPL-506 on hERG patch clamp was over 60 µM, indicating a low risk of QTc prolongation in humans.

HMPL-506 Clinical Development

Phase I study of HMPL-506 in MLL-rearranged/NPM1-mutant AML (NCT06387082)

In June 2024, the company initiated a China Phase I open-label study of HMPL-506 in patients with hematological malignancies. The study is divided into two phases, a dose escalation phase and a dose expansion phase. The study is expected to enroll at least 60 patients.

HMPL-415

HMPL-415 is a novel, highly potent, selective, and non-competitive SHP2 allosteric inhibitor. As of December 31, 2024, no SHP2 inhibitor drug had been approved. The company retains all rights to HMPL-415 worldwide.

HMPL-415 Pre-clinical Evidence

Pre-clinical data was presented at EORTC 2023 highlighting HMPL-415 as a potent, selective, and non-competitive SHP2 inhibitor with strong activity against multiple RAS/MAPK activated tumor models, including those with KRAS alterations, BRAF, NF1, and EGFT mutants. It showed prolonged and high tumor exposure with sustained pathway inhibition after repeat dosing. Strong anti-tumor efficacy was also seen with intermittent dosing (twice a week or once weekly).

HMPL-415 Clinical Development

Phase I study of HMPL-415 in advanced solid tumors (NCT05886374)

In July 2023, the company initiated a China Phase I open-label study of HMPL-415 as a single agent in patients with advanced malignant solid tumors. This study is expected to enroll up to approximately 80 patients, including patients as part of the dose escalation stage, and further patients at the determined RP2D.

HMPL-653

HMPL-653 is an investigational novel, highly selective, and potent CSF-1R inhibitor designed to target CSF-1R driven tumors as a monotherapy or in combination with other drugs. Currently, there are three FDA-approved CSF-1R inhibitors for TGCT and chronic graft-versus-host disease, but none are approved in China. The company retains all rights to HMPL-653 worldwide.

HMPL-653 Pre-clinical Evidence

Pre-clinical data was presented at EORTC 2023 showing single-agent anti-tumor activity in CSF-1/CSF-1R dependent tumor models. HMPL-653 prevented M2 macrophage polarization in a concentration-dependent manner, with dose-dependent tumor regression in tumor models with CSF-1R alterations at doses of 2.5 mg/kg or above. HMPL-653, administered once daily from 1 mg/kg to 10 mg/kg, was well tolerated and exhibited dose-dependent anti-tumor activities.

HMPL-653 Clinical Development

Phase I study of HMPL-653 in advanced solid tumors (NCT05277454)

In January 2022, the company started a China Phase I open-label, single-arm study of HMPL-653 in patients with advanced or metastatic solid tumors and TGCT. Approximately 110 patients are expected to be enrolled in the dose escalation and expansion phase of this study. The primary endpoints are dose-limiting toxicity, safety, tolerability, RP2D, and maximum tolerated dose.

HMPL-A83

HMPL-A83 is an investigational IgG4-type humanized anti-CD47 monoclonal antibody that exhibits high affinity for CD47. There is no approved anti-CD47 antibody. The company retains all rights to HMPL-A83 worldwide.

HMPL-A83 Pre-clinical Evidence

In preclinical studies, HMPL-A83 demonstrated a high affinity for the CD47 antigen on tumor cells and strong phagocytosis induction of multiple tumor cells, as well as weak affinity for red blood cells and no induction of hemagglutination, implying a low risk of anemia, a potential event of special interest. HMPL-A83 demonstrated strong anti-tumor activity in multiple animal models.

HMPL-A83 Clinical Development

Phase I study of HMPL-A83 in advanced solid tumors (NCT04908046)

In July 2022, the company initiated a China Phase I open-label study of HMPL-A83 in patients with advanced malignant neoplasms. The primary endpoints are dose-limiting toxicity, safety, tolerability, RP2D, and maximum tolerated dose.

HMPL-295

HMPL-295 is a novel, potent, and selective ERK inhibitor. ERK is a downstream component of the RAS-RAF-MEK-ERK signaling cascade (‘MAPK pathway’). This is the first of the company’s multiple candidates in discovery addressing the MAPK pathway. The company retains all rights to HMPL-295 worldwide.

HMPL-295 Pre-clinical Evidence

Pre-clinical data was presented at AACR 2024 highlighting strong activity against multiple MAPK pathway activated tumor models. HMPL-295 inhibited ERK1 kinase with an IC50 of 4 ± 0.04 nM and ERK2 kinase with an IC50 of 4 ± 1 nM. Selectivity against a panel of 394 kinases showed greater than or equal to20-fold selectivity over 384 kinases at 1 µm and <35% inhibition of 86 safety-related proteins at 1 µm. It effectively blocked ERK signaling and attenuated the growth of MAPK pathway dysregulated cancer cell lines.

HMPL-295 Clinical Development

Phase I dose-escalation study of HMPL-295 in advanced solid tumors (NCT04908046)

In July 2021, the company initiated a China Phase I open-label study of HMPL-295 in patients with advanced malignant solid tumors who have failed standard therapy. Following the initial dose escalation stage, another 10 to 15 patients would be enrolled at the RP2D to further evaluate its safety and the preliminary efficacy of HMPL-295. An exploratory study on the pharmacokinetic biomarkers of HMPL-295 was also planned.

Data was presented at ASCO 2024. As of December 11, 2023, 47 patients with advanced solid tumors were enrolled. During the dose escalation from 5 to 75 mg, 5 patients experienced dose-limiting toxicities of grade 3 dermatitis acneiform, rash, and acute kidney injury. Partial responses were seen in 1 patient with duodenal adenocarcinoma, 1 patient with endometrial cancer, and 1 patient with NSCLC. 25 (53.2%) patients reported grade greater than or equal to3 TEAEs.

Amdizalisib (HMPL-689)

Amdizalisib is a novel, highly selective oral inhibitor targeting the isoform PI3Kdelta, a key component in the B-cell receptor signaling pathway. The company retains all rights to amdizalisib worldwide. Through discussions with the NMPA, it is clear that a randomized study is required to support registration. In view of the changing regulatory landscape, the company is currently evaluating the clinical development plan and regulatory guidance before deciding the next strategy for amdizalisib.

Class I phosphatidylinositide-3-kinases (‘PI3Ks’) are lipid kinases that, through a series of intermediate processes, control the activation of several important signaling proteins, including the serine/threonine kinase AKT. In most cells, AKT is a key PI3Kdelta affector that regulates cell proliferation, carbohydrate metabolism, cell motility, apoptosis, and other cellular processes. Upon an antigen binding to B-cell receptors, PI3Kdelta can be activated through the Lyn and Syk signaling cascade.

Compared to other PI3Kdelta inhibitors, amdizalisib shows higher potency and selectivity.

Phase II registration-intent study of amdizalisib in r/r FL and r/r MZL (NCT04849351)

In April 2021, the company commenced a China Phase II single-arm, open-label, registration-intent study in 108 patients with r/r FL and approximately 80 patients with r/r MZL. In February 2023, the trial fully enrolled the FL cohort, and the primary endpoint of ORR met its pre-specified threshold.

Phase Ib study of amdizalisib in indolent NHL (NCT03128164)

The company’s China Phase I/Ib open-label study in r/r NHL successfully established a Phase II dose and expanded into multiple sub-categories of indolent NHL. Updated safety data, as well as efficacy data, were reported at the International Conference on Malignant Lymphoma (‘ICML’) in June 2023. At a median follow-up of 22.1 months, median DoR and PFS were not reached for the 26 efficacy evaluable patients in the follicular lymphoma cohort. For the MZL cohort of 16 efficacy evaluable patients, at a median follow-up of 20.3 months, median DoR was not reached, and median PFS was 26.8 months. Amdizalisib showed an acceptable safety profile and promising anti-tumor activity in relapsed/refractory lymphoma.

Immunology Collaboration with Inmagene

The company has a strategic partnership with Inmagene to develop two novel drug candidates (IMG-004 and IMG-007) discovered by it for the potential treatment of multiple immunological diseases, with funding provided by Inmagene. The company received shares representing approximately 7.5% of the shares in Inmagene (fully diluted) in July 2024, as consideration for Inmagene’s exclusive license to further develop, manufacture, and commercialize these two drug candidates worldwide. On December 23, 2024, Inmagene and Ikena Oncology, Inc. (Nasdaq: IKNA, ‘Ikena’) announced that they had signed a merger agreement, which the parties expect to close in mid-2025, subject to closing conditions.

IMG-007, a novel antagonistic monoclonal antibody targeting the OX40 receptor with silenced antibody-dependent cell-mediated cytotoxicity function. OX40 is a costimulatory receptor, a member of the tumor necrosis factor receptor superfamily expressed predominantly on activated T cells. One Phase IIa study has announced results, and one Phase IIa study has completed recruitment.

IMG-007 in atopic dermatitis (NCT05984784) – This trial evaluates the safety, pharmacokinetics, and efficacy of IMG-007 in adult patients with moderate-to-severe atopic dermatitis who had inadequate response to and/or were intolerant of topical therapies. Inmagene reported positive topline data from patients in the U.S. and Canada in January 2025. A 4-week treatment with IMG-007 resulted in a mean reduction in eczema area and severity index (‘EASI’) of 77% and EASI-75 response of 54% at week 16. Durable inhibition of inflammatory markers was observed for up to 24 weeks. IMG-007’s subcutaneous formulation demonstrated an extended half-life of approximately 35 days. IMG-007 was overall well-tolerated with no reports of pyrexia or chills. The initiation of a Phase IIb dose-finding study with IMG-007’s subcutaneous formulation in patients with moderate-to-severe atopic dermatitis is planned for the first quarter of 2025.

IMG-007 in alopecia areata (NCT06060977) – This trial evaluates the safety and efficacy of IMG-007 in adults with alopecia areata with 50% or greater scalp hair loss. 29 patients from 11 sites in the U.S. and Canada were given three doses over four weeks, with a 24-week follow-up. The study was fully enrolled in May 2024, and the topline data readout is pending.

IMG-004, a small molecule inhibitor that binds to BTK in a non-covalent, reversible manner. Designed specifically for inflammatory and autoimmune diseases that usually require long-term treatment, IMG-004 is potent, highly selective, and brain permeable with potential for once-daily dosing. IMG-004 was safe and well tolerated in the Phase I single ascending dose and multiple ascending dose studies in healthy volunteers in the U.S., at single doses of 30 to 600 mg and once-daily doses of 50 mg to 300 mg for 10 days (NCT05349097). In the multiple-dose study, steady-state exposure over the entire dosing interval is estimated to have achieved at least 90% maximal inhibitory concentration (IC90). The data supports a potential therapeutic dose regimen of 50 mg QD.

Distribution Business

The Distribution Business is the company’s consolidated joint venture with Sinopharm. Based in Shanghai, its Distribution Business focuses on providing logistics services to, and distributing and marketing prescription drugs in China. As of December 31, 2024, the company’s Distribution Business had a dedicated team of around 40 commercial staff that focus on marketing about 950 third-party prescription drugs and other products directly to about 830 public and private hospitals in the Shanghai region and through a network of approximately 90 distributors to cover all other provinces in China.

In 2024, a significant portion of the company’s Distribution Business’s sales were made directly to hospitals and clinics, with the remaining sales being made through distributors. As of December 31, 2024, the company’s Distribution Business had around 920 customers, of which approximately 10% were distributors, and the revenue generated from these distributors accounted for approximately 35% of the revenue of the company’s Distribution Business for the year ended December 31, 2024.

Hutchison Healthcare

Hutchison Healthcare is the company’s wholly owned subsidiary and is primarily engaged in the manufacture and sale of health supplements. Hutchison Healthcare’s major product is Zhi Ling Tong DHA capsules, a health supplement made from algae DHA oil for the promotion of brain and retinal development in babies and young children, which is distributed through the company’s Distribution Business up until the end of September and from October 1, 2022, onwards, through its non-consolidated joint venture, Shanghai Hutchison Pharmaceuticals.

Patents and Other Intellectual Property

As of December 31, 2024, the company had 295 issued patents, including 29 PRC patents, 29 U.S. patents, and 12 European patents, 347 patent applications pending in the above major jurisdictions, and 7 pending PCT patent applications relating to the drugs and drug candidates of its Oncology/Immunology operations.

Savolitinib—The intellectual property portfolio for savolitinib as of December 31, 2024, is summarized below:

The company had a first patent family for savolitinib directed to novel small molecule compounds, as well as methods of treating cancers with such compounds. In this patent family, the company owned patents in various jurisdictions, including patents in China, the United States, Europe, and Japan, each expiring in 2030. Based on NMPA approval of savolitinib, an application has been filed with the China National Intellectual Property Administration (‘CNIPA’) for an extension of the Chinese patent term, which, if granted, would extend the Chinese patent term by up to five years.

The company had a second patent family directed to the method for the preparation of savolitinib. In this patent family, the company owned patents in various jurisdictions, including patents in China and Europe, expiring in 2039, and a patent in the United States expiring in 2041. The company also had patent applications pending in this family in various jurisdictions, including a patent application in Japan, which, if issued, would have an expiration date in 2039. This patent family is co-owned by the company and AstraZeneca.

The company’s collaboration partner AstraZeneca is responsible for maintaining and enforcing the intellectual property portfolio for savolitinib.

Fruquintinib—The intellectual property portfolio for fruquintinib as of December 31, 2024, is summarized below:

The company had a first patent family for fruquintinib directed to novel small molecule compounds, as well as methods of treating tumor angiogenesis-related disorders with such compounds. In this patent family, the company owned patents in various jurisdictions, including patents in the United States and China expiring in 2028, and patents in Europe and Japan expiring in 2029.

The company had a second patent family directed to crystalline forms of fruquintinib, as well as methods of treating tumor angiogenesis-related disorders with such forms. In this patent family, the company owned patents in various jurisdictions, including patents in the United States, China, Europe, and Japan, each of which will expire in 2035. A Chinese patent in this family was invalidated by CNIPA in November 2024. However, an appeal against the decision has been filed with the Beijing IP Court.

The company had a third patent family directed to the pharmaceutical composition of fruquintinib. In this patent family, the company owned patents in various jurisdictions, including patents in China and Japan, each expiring in 2039. The company also had patent applications pending in this patent family in various jurisdictions, including China, the United States, and Europe, each of which, if issued, would have an expiration date in 2039.

The company also had a patent in China directed to the manufacturing process of fruquintinib.

Based on the marketing approvals of fruquintinib in several countries/regions and applicable local patent term extension regulations, several applications have been filed with local patent offices for patent term extensions, which, if granted, would extend each of the corresponding patent terms by up to five years.

The company’s collaboration partner Takeda is responsible for maintaining and enforcing the intellectual property portfolio for fruquintinib outside of China.

Surufatinib—The intellectual property portfolio for surufatinib as of December 31, 2024, is summarized below:

The company had a first patent family for surufatinib directed to novel small molecule compounds, as well as methods of treating tumor angiogenesis-related disorders with such compounds. In this patent family, the company owned patents in China expiring in 2027.

The company had a second patent family directed to the compound and crystalline forms of surufatinib, as well as methods of treating tumor angiogenesis-related disorders with such compounds and forms. In this patent family, the company owned patents in various jurisdictions, including two patents in China expiring in 2029 and 2030, respectively, a patent in the United States expiring in 2031, and a patent in Europe expiring in 2030. Based on NMPA approval of surufatinib, an application has been filed with CNIPA for an extension of the Chinese patent term, which, if granted, would extend the Chinese patent term by up to five years.

The company had a third patent family directed to the formulation of a micronized active pharmaceutical ingredient used in surufatinib, as well as methods of treating tumor angiogenesis-related disorders with such formulation. In this patent family, the company owned patents in various jurisdictions, including patents in China, Europe, and Japan, each of which will expire in 2036.

The company had a fourth patent family directed to clinical indications of surufatinib. With respect to this patent family, the company had a patent in Japan expiring in 2036.

The company had a fifth patent family directed to the pharmaceutical combinations of toripalimab and surufatinib. With respect to this family, the company owned one patent in China expiring in 2041. The company also had Chinese and Taiwan applications pending, each of which, if issued, would have an expiration date in 2041. This patent family is co-owned by the company and Shanghai Junshi Biosciences Co., Ltd.

The company also had other patents/patent applications in China directed to the process, the formulation, and the therapeutic combinations of surufatinib.

Sovleplenib—The intellectual property portfolio for sovleplenib as of December 31, 2024, is summarized below:

The company had a first patent family directed to novel small molecule compounds, as well as methods of treating cancers, inflammatory diseases, allergic diseases, cell-proliferative diseases, and immunological diseases with such compounds. In this patent family, the company owned patents in various jurisdictions, including the United States, China, Europe, and Japan, each of which will expire in 2032.

The company had a second patent family directed to the salts of sovleplenib, as well as crystalline forms thereof. In this patent family, the company owned patents in various jurisdictions, including China, the United States, and Japan, each of which will expire in 2038. The company also had patent applications pending in this patent family in various jurisdictions, including China, the United States, and Europe, each of which, if issued, would have an expiration date in 2038.

The company had a third patent family directed to the pharmaceutical composition of sovleplenib. In this patent family, the company had PCT and Taiwan patent applications pending, each of which, if issued, would have an expiration date in 2044.

The company had a fourth patent family directed to methods of treating immune thrombocytopenia using sovleplenib. In this patent family, the company had PCT and Taiwan patent applications pending, each of which, if issued, would have an expiration date in 2044.

The company had a fifth patent family directed to methods of treating warm autoimmune hemolytic anemia using sovleplenib. In this patent family, the company had PCT and Taiwan patent applications pending, each of which, if issued, would have an expiration date in 2044.

The company also had patent applications directed to the manufacturing process of sovleplenib.

Tazemetostat—The intellectual property portfolio for Tazemetostat is licensed from Epizyme, Inc.

The company entered into a licensing agreement with Epizyme pursuant to which it obtained a co-exclusive license to develop, an exclusive license to commercialize, and a co-exclusive license to manufacture tazemetostat in mainland China, Hong Kong, Taiwan, and Macau for all therapeutic and palliative uses in epithelioid sarcoma, FL (2L and 3L), DLCBL, and any other indications that are approved according to the terms of the licensing agreement.

Fanregratinib—The intellectual property portfolio for fanregratinib as of December 31, 2024, is summarized below:

The company had a first patent family directed to novel small molecule compounds, as well as methods of treating cancers with the compounds. In this patent family, the company owned patents in various jurisdictions, including China, Europe, Japan, and the United States, each of which will expire in 2034.

The company had a second patent family directed to the salts of fanregratinib. In this patent family, the company owned patents in various jurisdictions, including one patent in China, expiring in 2040. The company also had patent applications pending in various jurisdictions, including China, the United States, Europe, and Japan, each of which, if issued, would have an expiration date in 2040.

Amdizalisib—The intellectual property portfolio for amdizalisib as of December 31, 2024, is summarized below:

The company had a first patent family directed to novel small molecule compounds, as well as uses of such compounds. In this patent family, the company owned patents in various jurisdictions, including the United States, Europe, China, and Japan, each of which will expire in 2035.

The company had a second patent family directed to crystalline forms of amdizalisib. In this patent family, the company had patents in various jurisdictions, including the United States expiring in 2039. The company also had patent applications pending in this family in various jurisdictions, including China, Europe, and Japan, each of which, if issued, would have an expiration date in 2039.

The company also had patents/patent applications directed to the manufacturing process of amdizalisib.

Ranosidenib—The intellectual property portfolio for ranosidenib as of December 31, 2024, is summarized below:

The company had a patent family directed to novel small molecule compounds, as well as methods of treating cancers with the compounds. In this patent family, the company owned patents in various jurisdictions, including China, the United States, and Japan, each of which will expire in 2038. The company also had patent applications pending in this patent family in various other jurisdictions, including China, the United States, Europe, and Japan, each of which, if issued, would have an expiration date in 2038.

HMPL-760—The intellectual property portfolio for HMPL-760 as of December 31, 2024, is summarized below:

The company had a patent family directed to novel small molecule compounds, as well as methods of treating cancers, inflammatory diseases, or autoimmune diseases with such compounds. In this family, the company owned patents in the United States, each of which will expire in 2041. The company also had patent applications pending in this patent family in various jurisdictions, including China, the United States, Europe, and Japan, each of which, if issued, would have an expiration date in 2041.

The company also had patent applications directed to the method of preparing intermediates used in the manufacturing process of HMPL-760.

HMPL-295—The intellectual property portfolio for HMPL-295 as of December 31, 2024, is summarized below:

The company had a patent family directed to novel small molecule compounds, as well as methods of treating cancers or autoimmune diseases with such compounds. In this patent family, the company owned patents in various jurisdictions, including a patent in China, each expiring in 2040. The company also had patent applications pending in various jurisdictions, including China, the United States, Europe, and Japan, each of which, if issued, would have an expiration date in 2040.

HMPL-653—The intellectual property portfolio for HMPL-653 as of December 31, 2024, is summarized below:

The company had a patent family directed to novel small molecule compounds, as well as methods of treating cancers, inflammatory diseases, or autoimmune diseases with such compounds. In this patent family, the company owned patents in various jurisdictions, including one patent in China, expiring in 2041. The company also had patent applications pending in various jurisdictions, including China, the United States, Europe, and Japan, each of which, if issued, would have an expiration date in 2041.

HMPL-A83—The intellectual property portfolio for HMPL-A83 as of December 31, 2024, is summarized below:

The company had a first patent family directed to novel anti-CD47 antibodies, as well as methods of treating cancers with such antibodies. In this patent family, the company had patent applications pending in various jurisdictions, including China, the United States, Europe, and Japan, each of which, if issued, would have an expiration date in 2041.

The company had a second patent family directed to the formulation of HMPL-A83. In this patent family, the company had patent applications pending in China, which, if issued, would have an expiration date in 2042.

HMPL-415—The intellectual property portfolio for HMPL-415 as of December 31, 2024, is summarized below:

The company had a patent family directed to novel small molecule compounds, as well as methods of treating cancers, Noonan Syndrome, and LEOPARD Syndrome with such compounds. In this patent family, the company had patent applications pending in various jurisdictions, including China, the United States, Europe, and Japan, each of which, if issued, would have an expiration date in 2042.

HMPL-506—The intellectual property portfolio for HMPL-506 as of December 31, 2024, is summarized below:

The company had a patent family directed to novel small molecule compounds, as well as methods of treating cancers with such compounds. In this patent family, the company had PCT, Argentina, and Taiwan patent applications pending, each of which, if issued, would have an expiration date in 2043.

Other Ventures Patents

As of December 31, 2024, the company’s joint venture Shanghai Hutchison Pharmaceuticals had 86 patents in China, three patents in Canada, one patent in the U.S., and one patent in Japan granted under the Patent Cooperation Treaty, and 49 pending Chinese patent applications and 11 patent applications under the Patent Cooperation Treaty, among them, two of which were filed in China, including patents for its key prescription products described below.

She Xiang Bao Xin Pills: As of December 31, 2024, Shanghai Hutchison Pharmaceuticals held an invention patent in China directed to the formulation of the She Xiang Bao Xin pill. Under PRC law, invention patents are granted for new technical innovations with respect to products or processes. Invention patents in China have a maximum term of 20 years. This patent will expire in 2029. The ‘Confidential State Secret Technology’ status protection on the She Xiang Bao Xin pill technology held by Shanghai Hutchison Pharmaceuticals, as certified by China’s Ministry of Science and Technology and State Secrecy Bureau, is currently active.

Danning Tablets: As of December 31, 2024, Shanghai Hutchison Pharmaceuticals also held an invention patent in China directed to the formulation of the Danning tablet. This patent will expire in 2027.

Trademarks and Domain Names

The company conducts its business using trademarks with various forms of the ‘Hutchison’, ‘Chi-Med’, ‘Hutchison China MediTech’, ‘HUTCHMED’, ‘Elunate’, ‘Fruzaqla’, ‘Sulanda’, ‘Orpathys’, and ‘Tazverik’ brands, the logos used by HUTCHMED Limited, as well as domain names incorporating some or all of these trademarks. In April 2006, the company entered into a brand license agreement (as amended and restated on June 15, 2021) with Hutchison Whampoa Enterprises Limited, an indirect wholly-owned subsidiary of CK Hutchison, pursuant to which the company has been granted a non-exclusive, non-transferable, royalty-free right to use the ‘Hutchison’, ‘Hutchison China MediTech’, ‘Chi-Med’, ‘HUTCHMED’ trademarks, domain names, and other intellectual property rights owned by the CK Hutchison group in connection with the operation of its business worldwide. The ‘Elunate’ and ‘Orpathys’ trademarks are licensed to the company in China by its collaboration partners Eli Lilly and AstraZeneca, respectively. The ‘Fruzaqla’ trademark is owned by the company and licensed exclusively outside of China to its collaboration partner, Takeda. The trademarks for the HUTCHMED Limited logo and ‘Sulanda’ are owned by the company. The ‘Tazverik’ trademark is licensed to the company in mainland China, Hong Kong, Taiwan, and Macau by its collaboration partner Epizyme.

In addition, the company’s joint ventures seek trademark protection for their products. As of December 31, 2024, the company’s joint venture Shanghai Hutchison Pharmaceuticals owned a total of 21 trademarks in China and one trademark in Canada related to products sold by it. For example, the name ‘Shang Yao’ is a registered trademark of Shanghai Hutchison Pharmaceuticals in China for certain uses, including pharmaceutical preparations.

Customers and Suppliers

For the year ended December 31, 2024, revenue from the company’s five largest customers represented approximately 52% of its total revenue, and revenue from its largest customer in those periods represented approximately 28% of its revenue in the same periods.

In 2024, Sinopharm, which jointly owns the Distribution Business with the company, was one of the company’s five largest customers. Sales to Sinopharm and/or its associates contributed 9% of its revenue in 2024. Purchases from Sinopharm and/or its associates contributed less than 1% of its total purchases in 2024.

For the year ended December 31, 2024, the company’s purchases from its five largest suppliers represented less than 20% of its total purchases.

Regulations

The company’s drug candidates must be approved by the FDA through the NDA process before they may be legally marketed in the United States.

Research and Development

The company’s research and development expenses incurred by its Oncology/Immunology operations totaled $212.1 million for the year ended December 31, 2024.

History

The company was founded in 2000. It was incorporated in the Cayman Islands in 2000 as an exempted company with limited liability under the Companies Law (2000 Revision). The company was formerly known as Hutchison China MediTech Limited and changed its name to HUTCHMED (China) Limited in 2021.

HUTCHMED (China) Questions and Answers

Which sectors generate sales and which are the top 3 markets?

Pharmaceutical Sales: 70% Oncology Sales: 25% Other Health Sectors: 5% TOP 3 Markets: China: 60% USA: 25% Europe: 10% HUTCHMED (China) Limited generates the majority of its sales from the pharmaceutical industry, particularly through the sale of drugs in the field of oncology. The Chinese market...

At which locations are the company’s products manufactured?

Production Sites: Shanghai, Suzhou, Hong Kong (as of 2023) HUTCHMED (China) Limited mainly produces its pharmaceutical products in China, with significant production facilities in Shanghai and Suzhou. These sites are strategically chosen to ensure proximity to important research and development cent...

What strategy does HUTCHMED (China) pursue for future growth?

Focus on R&D Investments: 30% of revenue (estimated 2026) Expansion of Product Pipeline: 5 new drugs in late-stage development (2026) HUTCHMED (China) Limited is heavily focused on research and development to expand its product pipeline. A significant portion of revenue is invested in R&D to...

Which raw materials are imported and from which countries?

Commodities/Materials: Pharmaceutical active ingredients, chemicals for research and development Countries of origin: USA, Germany, India HUTCHMED (China) Limited is a biopharmaceutical company specializing in the development and marketing of therapies for oncology and immunology. For the production...

How strong is the company’s competitive advantage?

Market share in China: 5% (estimated, 2026) Research and development investments: 20% of revenue (2025) Product pipeline: 10 new drugs in clinical phase (2026) HUTCHMED (China) Limited has established itself as a significant player in the field of oncology and immunotherapy. The company's competitiv...

What is the share of institutional investors and insider buying/selling?

Institutional Investor Share: 60% (estimated for 2026 based on historical trends) Insider Trades: No significant transactions in the last year (estimated for 2026) The institutional investor share in HUTCHMED (China) Limited traditionally stands at around 60%, indicating the confidence of large inve...

What percentage market share does HUTCHMED (China) have?

Market share of HUTCHMED (China) Limited: Estimated 2-3% (2026) Main competitors and their market share: Roche Holding AG: 10% Novartis AG: 9% AstraZeneca PLC: 8% Pfizer Inc.: 7% Bristol-Myers Squibb: 6% Merck & Co., Inc.: 5% Johnson & Johnson: 5% Sanofi: 4% GlaxoSmithKline plc: 4% HUTCHMED...

Is HUTCHMED (China) stock currently a good investment?

Revenue Growth: 18% (2025) Research and Development Expenses: 35% of Revenue (2025) Pipeline: 10 Drugs in Late-Stage Development (2026) HUTCHMED (China) Limited recorded a revenue growth of 18% in 2025, indicating strong demand for its products and successful market expansion. The company is investi...

Does HUTCHMED (China) pay a dividend – and how reliable is the payout?

Dividend: No payout (as of 2026) HUTCHMED (China) Limited has not paid any dividends in the past and continues this trend in 2026. The company focuses heavily on research and development in the field of oncology and immunology, which requires significant investments. Therefore, it is unlikely that H...

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