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HUTCHMED Reports 2025 Interim Results - Indications expansion driving growth and ATTC platform enriching pipeline - - $455 million in net income attributable to HUTCHMED driven by non-core partial disposal - Hong Kong, S

Key Takeaway: HUTCHMED has released its interim results for the first half of 2025, reporting a net income of $455 million primarily due to a non-core partial disposal. The company highlighted the promising developments from its ATTC platform and the approval of ORPATHYS in China, indicating potential for future growth. However, it also experienced a decrease in total in-market sales by 4% and a significant drop in consolidated revenue by 22%, largely attributed to competitive pressures. Looking ahead, HUTCHMED anticipates improved sales growth in the latter half of 2025 through indication expansion and enhanced market strategies.

Market Sentiment Analysis

POSITIVE FACTORS

  • HUTCHMED reported a strong net income of $455 million due to non-core disposals.
  • The ATTC platform is poised to enrich the company's pipeline with new drug candidates.
  • Approval of ORPATHYS in China ahead of schedule demonstrates the company's effective operations.
  • Sales growth is expected to improve in the second half of 2025 due to indication expansion and better market penetration.

CONCERNS & RISKS

  • Total in-market sales decreased by 4% and consolidated revenue dropped 22% due to lower sales in China.
  • Sales for some oncology products like ELUNATE and SULANDA saw significant declines.
  • The company faces intensified competition as existing products mature.

Full Press Release Details

HUTCHMED Reports 2025 Interim Results
- Indications expansion driving growth and ATTC platform enriching pipeline -
- $455 million in net income attributable to HUTCHMED driven by non-core partial disposal -
Hong Kong, Shanghai & Florham Park, NJ - Thursday, August 7, 2025: HUTCHMED (China) Limited ("HUTCHMED", the "Company" or "we") (Nasdaq/AIM:HCM; HKEX:13) today reports its financial results for the six months ended June 30, 2025 and provides updates on key clinical and commercial developments.
HUTCHMED to host results webcasts today at 8:00 a.m. EDT / 1:00 p.m. BST / 8:00 p.m. HKT in English on Thursday, August 7, 2025, and tomorrow at 8:30 a.m. HKT in Chinese (Putonghua) on Friday, August 8, 2025. After registration, investors may access the live webcast at www.hutch-med.com/event.
All amounts are expressed in US dollars unless otherwise stated. A list of abbreviations is in the Glossary on page 36.
Global commercial progress and delivery of sustainable growth
Pipeline progress and new technology platform
Dr Dan Eldar, Non-executive Chairman of HUTCHMED, said, "With a strong balance sheet, robust operations and an exciting new ATTC platform, HUTCHMED is ready to enter a new phase of growth. Partnering is still a strategic focus, with multinational pharmaceutical companies remaining favorable towards such licensing opportunities with China biotech companies. In recent months we have seen markets' sentiment and performance have significantly improved. China domestic drug policy and pricing environment also manifest strengthened support for innovative drug development, with the potential introduction of a commercial insurance drug list later this year, targeting a diversified, multi-layered healthcare social security payment system down the road.
We intend to prudently and actively deploy resources to expedite the development of a series of drug candidates from our novel ATTC platform, including synchronous clinical development in China and overseas. Our 20 years of knowledge of in-house discovery, experience in running large-scale pivotal trials, collaboration with international partners and success in obtaining global regulatory approvals empower us to bring forth more innovative medicines to address large unmet needs around the world."
Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said, "We concluded the first half of 2025 with several important milestones achieved, some earlier than expected. The presentation of SACHI data at ASCO in a late-breaking oral presentation at the beginning of June was impressive, validating both the clinical strength and commercial advantages of ORPATHYS in the market. This is the first biomarker-selected pivotal study globally for EGFR TKI refractory lung cancer patients, demonstrating clear clinical benefits for these patients. The China approval of ORPATHYS at the end of June for this indication, six months after filing acceptance, was ahead of schedule and in time to qualify for national reimbursement negotiation. Also in June, the third indication of ELUNATE for kidney cancer was accepted for review by the NMPA, supported by positive data in the FRUSICA-2 Phase III trial, to be presented at ESMO Congress. We also launched TAZVERIK (tazemetostat), our first hematological oncology drug, in July following approval in March.
We believe sales growth should improve in second half of 2025, with the help of indication expansion in China and better market penetration overseas. In the near term, we shall start clinical development of multiple drug candidates from our ATTC program, a crucial technology platform, which will enrich our pipeline and provide ample partnership opportunities."
2025 INTERIM RESULTS & BUSINESS UPDATES
I. COMMERCIAL OPERATIONS
FRUZAQLA in-market sales by Takeda were up 25% in the first half of 2025 at $162.8 million, driven by strong growth following approvals in more than 30 countries to date, including over 10 new markets in 2025. Reimbursement was received in the US, Spain and Japan last year, and in July 2025, positive recommendation was received for NHS reimbursement in England and Wales.
The China pharmaceutical sector has gone through multifaceted changes. To position HUTCHMED for sustainable long-term growth, HUTCHMED has streamlined its sales force to establish a more efficient commercial organization and enhance productivity. In the face of intensifying competition as its products mature, HUTCHMED has strengthened its strategy to continue to focus on science-driven commercial activities to further differentiate its products. In the first half of 2025, in-market sales in China for ELUNATE , SULANDA and ORPATHYS decreased as compared to the first half of 2024, reflecting competition and the transitional effects of the changes in our sales team and marketing strategy.
Total in-market sales were down 4%. Consolidated revenue dropped 22% due to lower China in-market sales, offset by flat FRUZAQLA revenue.
Other Oncology/Immunology revenue, consisting of upfront or milestones, R&D services and licensing to our partners increased 9% to $44.4 million. Revenue from Other Ventures, comprising prescription drug distribution, remained flat, leading to total consolidated revenue of $277.7 million, down 9%.
In-market Sales* Consolidated Revenue**
(Unaudited, $ in millions) H1 2025 H1 2024 % (CER) H1 2025 H1 2024 % (CER)
FRUZAQLA $ 162.8 $ 130.5 +25% (+25%) $ 43.1 $ 42.8 +1% (+1%)
ELUNATE $ 43.0 $ 61.0 -29% (-29%) $ 33.6 $ 46.0 -27% (-27%)
SULANDA $ 12.7 $ 25.4 -50% (-50%) $ 12.7 $ 25.4 -50% (-50%)
ORPATHYS $ 15.2 $ 25.9 -41% (-41%) $ 9.0 $ 13.1 -32% (-32%)
TAZVERIK $ 0.7 $ 0.5 +49% (+49%) $ 0.7 $ 0.5 +49% (+49%)
Oncology Products $ 234.4 $ 243.3 -4% (-4%) $ 99.1 $ 127.8 -22% (-22%)
Takeda upfront, regulatory milestones and R&D services $ 29.5 $ 33.8 -13% (-13%)
Other revenue (R&D services and licensing) $ 14.9 $ 7.1 +111% (+111%)
Total Oncology/Immunology $ 143.5 $ 168.7 -15% (-15%)
Other Ventures $ 134.2 $ 137.0 -2% (-1%)
Total Revenue $ 277.7 $ 305.7 -9% (-9%)
* FRUZAQLA , ELUNATE and ORPATHYS mainly represent total sales to third parties as provided by Takeda, Eli Lilly and AstraZeneca, respectively.
** FRUZAQLA represents manufacturing revenue and royalties paid by Takeda; ELUNATE represents manufacturing revenue, promotion and marketing services revenue and royalties paid by Eli Lilly to HUTCHMED, and sales to other third parties invoiced by HUTCHMED; ORPATHYS represents manufacturing revenue and royalties paid by AstraZeneca to HUTCHMED and sales to other third parties invoiced by HUTCHMED; SULANDA and TAZVERIK represent the HUTCHMED's sales of the products to third parties.
II. REGULATORY UPDATES
III. LATE-STAGE CLINICAL DEVELOPMENT ACTIVITIES
Savolitinib (ORPATHYS in China), a highly selective oral inhibitor of MET
Potential upcoming clinical milestones for savolitinib:
Fruquintinib (ELUNATE in China, FRUZAQLA outside of China), a selective oral inhibitor of VEGFR
Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk
Potential upcoming regulatory milestones for sovleplenib:
Surufatinib (SULANDA in China), an oral inhibitor of VEGFR, FGFR and CSF-1R
Potential upcoming clinical milestone for surufatinib:
Tazemetostat (TAZVERIK in China), a first-in-class, oral inhibitor of EZH2
Fanregratinib (HMPL-453), a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3
Ranosidenib (HMPL-306), an investigative and highly selective oral dual-inhibitor of IDH1 and IDH2 enzymes
IV. ANTIBODY-TARGETED THERAPY CONJUGATE (ATTC) PLATFORM
New in-house created platform with multiple potential IND candidates
HUTCHMED plans to initiate China and global clinical trials for our first ATTC drug candidate around the end of 2025, followed by multiple global IND filings for more ATTC candidates in 2026.
Our ATTC next-generation technology platform leverages over 20 years of expertise in targeted therapies with small molecules inhibitors. By linking a monoclonal antibody with a proprietary targeted small-molecule inhibitor (SMI) payload, our ATTC platform has the capability to derive multiple drug candidates targeting various oncology indications, including precision medicine against selective sub-types. These ATTC drug candidates enrich the next wave of clinical development with potential key advantages over traditional antibody-drug conjugates and/or small molecule medicines.
V. COLLABORATION UPDATES
Further progress of candidate IMG-007, discovered by HUTCHMED
In April 2025, the 2024 Sustainability Report was published, highlighting the progress made in 11 goals and targets and enhanced climate actions, including improved Scope 3 data, tightened control over air travel and engagement with suppliers. This year, a comprehensive climate risks assessment is being conducted to further understand and quantify the potential financial impacts of climate change, including physical risks brought by flooding and heat stress, and transition risks for HUTCHMED under optimistic and pessimistic scenarios.
HUTCHMED has made notable progress in its ESG ratings, including ratings from CDP Worldwide, the Hang Seng Corporate Sustainability Index Series, ISS ESG, MSCI ESG, Sustainalytics, and S&P Global ESG. In May 2025, HUTCHMED ranked third in ESG Excellence in the Healthcare, Pharmaceutical, and Biotechnology sector in the Extel's Asia Executive Team survey, reflecting feedback from over 5,400 portfolio managers and analysts. Extel ranked HUTCHMED as one of the Most Honored Companies; ranked it first in Best Board of Directors, Best CEO, Best IR Program and Best IR Professionals; as well as second in Best CFO and Best IR Team in the Healthcare, Pharmaceutical, and Biotechnology sector.
FINANCIAL HIGHLIGHTS
Revenue for the six months ended June 30, 2025 was $277.7 million compared to $305.7 million for the six months ended June 30, 2024.
Net Expenses for the six months ended June 30, 2025 were $239.0 million compared to $279.9 million for the six months ended June 30, 2024, reflecting strong cost control efforts.
Gain on divestment of SHPL, net of tax was $416.3 million for the six months ended June 30, 2025.
Net Income attributable to HUTCHMED for the six months ended June 30, 2025 was $455.0 million compared to $25.8 million for the six months ended June 30, 2024.
Cash, Cash Equivalents and Short-Term Investments were $1,364.5 million as of June 30, 2025 compared to $836.1 million as of December 31, 2024.
Foreign exchange impact: The RMB depreciated against the US dollar on average by approximately 0.8% during the first half of 2025, which has impacted consolidated financial results as highlighted.
HUTCHMED updates full year 2025 guidance for Oncology/Immunology consolidated revenue to $270 million - $350 million due to the phasing of milestone income from partners to 2026 and onwards, as well as the estimated delay of sovleplenib China NDA review completion to after 2025. HUTCHMED will leverage its strong cash resources to accelerate ATTC global development and explore investment opportunities.
Shareholders and investors should note that:
Use of Non-GAAP Financial Measures and Reconciliation - References in this announcement to adjusted Group net cash flows excluding financing activities and financial measures reported at CER are based on non-GAAP financial measures. Please see the "Use of Non-GAAP Financial Measures and Reconciliation" for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively.
Condensed Consolidated Balance Sheets Data
As of As of
(in $'000) June 30, 2025 December 31, 2024
(Unaudited)
Assets
Cash and cash equivalents and short-term investments 1,364,520 836,110
Accounts receivable 146,967 155,537
Other current assets 80,840 74,908
Property, plant and equipment 94,573 92,498
Investment in an equity investee 3,645 77,765
Other non-current assets 85,395 37,378
Total assets 1,775,940 1,274,196
Liabilities and shareholders ' equity
Accounts payable 43,725 42,521
Other payables, accruals and advance receipts 221,061 256,124
Deferred revenue 77,628 98,503
Bank borrowings 93,444 82,806
Other liabilities 98,159 22,389
Total liabilities 534,017 502,343
Company ' s shareholders ' equity 1,229,064 759,929
Non-controlling interests 12,859 11,924
Total liabilities and shareholders ' equity 1,775,940 1,274,196
Condensed Consolidated Statements of Operations Data
(Unaudited, in $'000, except share and per share data) Six months ended June 30,
2025 2024
Revenue:
Oncology/Immunology - Marketed Products 99,039 127,796
Oncology/Immunology - R&D 44,408 40,841
Oncology/Immunology Consolidated Revenue 143,447 168,637
Other Ventures 134,230 137,044
Total revenue 277,677 305,681
Operating expenses:
Cost of revenue (167,577) (180,135)
Research and development expenses (71,990) (95,256)
Selling and administrative expenses (41,624) (57,811)
Total operating expenses (281,191) (333,202)
(3,514) (27,521)
Gain on divestment of an equity investee 477,456 -
Other income, net 21,650 22,765
Income/(loss) before income taxes and equity in earnings of an equity investee 495,592 (4,756)
Income tax expense (2,029) (2,886)
Income tax expense - Divestment of an equity investee (61,133) -
Equity in earnings of an equity investee, net of tax 23,125 33,807
Net income 455,555 26,165
Less: Net income attributable to non-controlling interests (601) (364)
Net income attributable to HUTCHMED 454,954 25,801
Earnings per share attributable to HUTCHMED (US$ per share)
- basic 0.53 0.03
- diluted 0.52 0.03
Number of shares used in per share calculation
- basic 857,038,725 856,030,704
- diluted 872,564,513 872,534,466
Earnings per ADS attributable to HUTCHMED (US$ per ADS)
- basic 2.65 0.15
- diluted 2.61 0.15
Number of ADSs used in per ADS calculation
- basic 171,407,745 171,206,141
- diluted 174,512,903 174,506,893
Investor Enquiries +852 2121 8200 / ir@hutch-med.com
Media Enquiries
FTI Consulting - +44 20 3727 1030 / HUTCHMED@fticonsulting.com
Ben Atwell / Alex Shaw +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
Brunswick - Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
Panmure Liberum Nominated Advisor and Joint Broker
Atholl Tweedie / Emma Earl / Rupert Dearden +44 20 7886 2500
Cavendish Joint Broker
Geoff Nash / Nigel Birks +44 20 7220 0500
Deutsche Numis Joint Broker
Freddie Barnfield / Jeffrey Wong / Duncan Monteith +44 20 7260 1000
Unless the context requires otherwise, references in this announcement to the "Group," the "Company," "HUTCHMED," "HUTCHMED Group," "we," "us," and "our," mean HUTCHMED (China) Limited and its subsidiaries unless otherwise stated or indicated by context.
Past Performance and Forward-Looking Statements
The performance and results of operations of the Group contained within this announcement are historical in nature, and past performance is no guarantee of future results of the Group. This announcement contains forward-looking statements within the meaning of the "safe harbor" provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words like "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "pipeline," "could," "potential," "first-in-class," "best-in-class," "designed to," "objective," "guidance," "pursue," or similar terms, or by express or implied discussions regarding potential drug candidates, potential indications for drug candidates or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any of our drug candidates will be approved for sale in any market, that any approvals which have been obtained will continue to remain valid and effective in the future, or that the sales of products marketed or otherwise commercialized by HUTCHMED and/or its collaboration partners (collectively, "HUTCHMED's Products") will achieve any particular revenue or net income levels. In particular, management's expectations could be affected by, among other things: unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including the inability to meet our key study assumptions regarding enrollment rates, timing and availability of subjects meeting a study's inclusion and exclusion criteria and funding requirements, changes to clinical protocols, unexpected adverse events or safety, quality or manufacturing issues; the delay or inability of a drug candidate to meet the primary or secondary endpoint of a study; the delay or inability of a drug candidate to obtain regulatory approval in different jurisdictions or the utilization, market acceptance and commercial success of HUTCHMED's Products after obtaining regulatory approval; discovery, development and/or commercialization of competing products and drug candidates that may be superior to, or more cost effective than, HUTCHMED's Products and drug candidates; the impact of studies (whether conducted by HUTCHMED or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties on the commercial success of HUTCHMED's Products and drug candidates in development; the ability of HUTCHMED to manufacture and manage supply chains, including various third party services, for multiple products and drug candidates; the availability and extent of reimbursement of HUTCHMED's Products from third-party payers, including private payer healthcare and insurance programs and government insurance programs; the costs of developing, producing and selling HUTCHMED's Products; the ability to obtain additional funding when needed; the ability to obtain and maintain protection of intellectual property for HUTCHMED's Products and drug candidates; the ability of HUTCHMED to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the successful disposition of its non-core business; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes, and government investigations generally; and general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries, uncertainties regarding future global exchange rates, uncertainties in global interest rates, and geopolitical relations, sanctions and tariffs. For further discussion of these and other risks, see HUTCHMED's filings with the US Securities and Exchange Commission, on AIM and on HKEX. HUTCHMED is providing the information in this announcement as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
In addition, this announcement contains statistical data and estimates that HUTCHMED obtained from industry publications and reports generated by third-party market research firms. Although HUTCHMED believes that the publications, reports and surveys are reliable, HUTCHMED has not independently verified the data and cannot guarantee the accuracy or completeness of such data. You are cautioned not to give undue weight to this data. Such data involves risks and uncertainties and are subject to change based on various factors, including those discussed above.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018).
This announcement contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.
HUTCHMED discovers, develops, manufactures and markets targeted therapies and immunotherapies for the treatment of cancer and immunological diseases through a fully integrated team of approximately 890 scientists and staff, and an in-house oncology commercial organization of approximately 740 staff, based in Shanghai, Suzhou, Beijing and Hong Kong in China and New Jersey in the US.
Out of our 13 drug candidates in various stages of clinical trials, four medicines, fruquintinib, surufatinib, savolitinib and tazemetostat, have been approved in mainland China. Fruquintinib has also been approved in or launched in more than 30 countries, including the US, EU and Japan as of July 2025. Savolitinib has completed an overseas Phase II study and an ongoing Phase III study will potentially support global filings if data proves satisfactory. Our fifth medicine, sovleplenib, has been accepted for review by the NMPA in China, pending approval. Beyond these drug candidates, our novel discovery and early-stage development is focused on progressing drug candidates from our ATTC next-generation technology platform, which currently has several molecules in the pre-clinical stage.
RESEARCH & DEVELOPMENT
With US, EU and Japan approvals of fruquintinib in November 2023, June 2024 and September 2024, respectively, we now possess a track record of discovery, clinical development and regulatory submissions of an innovative medicine launched globally. Our strategy is aimed at accelerating our path to establish a long-term sustainable business, by prioritizing late-stage and registrational studies in China and partnering outside of China. HUTCHMED intends to continue to run early phase development programs for selected drug candidates internationally where we believe we can differentiate from a global perspective.
HUTCHMED plans to accelerate innovation through artificial intelligence (AI) integration, with a focus on key R&D stages to improve return on investment (ROI) and iterative learning. In the near term, we plan to expedite the identification of high-potential drug candidates and reduce late-stage pre-clinical attrition. In the medium-term, we target faster patient recruitment through better screening and clinical trial design, leading to R&D efficiency gain with an integrated AI platform.
Antibody-Targeted Therapy Conjugate Technology Platform
In January 2025, HUTCHMED announced its next-generation in-house technology platform in antibody-targeted therapy conjugates, or ATTCs. For over three years, we have invested significant resources into this new platform, which should provide multiple drug candidates in the future. Compared to traditional cytotoxin-based antibody-drug conjugates, the traditional toxin-based payload is replaced with a targeted small molecule. Thus, unlike traditional antibody-drug conjugates, ATTCs have potential to be administered in combination with chemotherapy or other targeted agents, which is particularly important in frontline settings.
Another benefit of such design is to further optimize the strength of the small-molecule drug, which may otherwise be limited by a narrow therapeutic window. Through a reduction of off-tumor or off-target toxicity, our platform is designed to deliver highly potent concentrations of small molecule inhibitors to target sites. This has potential to confer efficacy in a broad array of indications with high unmet needs and enable long-term usage. More generally, our ATTC platform has the potential to incorporate high molecular weight drug payloads such as proteolysis targeting chimeras (PROTACs) and protein-protein inhibitors (PPIs).
Pre-clinical data to date suggests robust anti-tumor activity and durable response with our ATTC candidates, compared to monoclonal antibodies in combination with targeted small molecule therapy in a variety of tumor types. IND-enabling work is ongoing and first global clinical trials, including in China, are expected to initiate in late 2025.
Below is a summary update of the clinical trial progress of our investigational drug candidates. For more details about each trial, please refer to recent scientific publications.
Savolitinib (ORPATHYS in China)
Mechanism of action: savolitinib is an oral, potent and highly selective inhibitor of MET. The MET pathway functions abnormally through amplification, overexpression and mutations. The aberrant activation of MET is correlated with tumor growth, survival, invasion, metastasis, suppression of cell death and angiogenesis. MET aberrations may contribute to drug resistance in NSCLC and CRC following anti-EGFR treatment.
Target indications: savolitinib was approved for METex14 NSCLC in 2021 in China, where there are 1.06 million new cases of lung cancer (226,000 in the US) in 2022, according to Globocan. About 80-85% are classified as NSCLC, with 2-3% in METex14. In June 2025, savolitinib expanded its indication to EGFRm MET amplified 2L NSCLC in combination with TAGRISSO . In China, 30-40% of NSCLC patients are EGFRm (10-15% in the US). After 1L treatment, about 60% will develop resistance and progress to 2L, of which 1/3 are driven by MET. Separately, MET is an oncogenic driver occurring in 4-6% of GC, leading to poor prognosis. We are developing additional indications for savolitinib in MET overexpressed 1L NSCLC, MET amplified 3L GC and MET-driven PRCC.
Clinical development: SACHI China Phase III data was presented at ASCO 2025 late-breaking oral presentation session with mPFS of 6.9 months (HR 0.32, p<0.0001) for 2L NSCLC patients who failed prior third-generation EGFR TKI. In a cross-trial comparison against an EGFR-MET bispecific antibody, savolitinib plus TAGRISSO combination shows superior PFS and CNS efficacy. The data also highlights the importance of tissue biopsy and FISH test for differentiated benefits for 2L NSCLC patients, in contrast to a lack of MET-specific data from competing modalities. Our SAFFRON global Phase III study is ongoing and targets to complete patient enrollment in the second half of 2025 and readout data in the first half of 2026.
Treatment Name: Indication (control); NCT# Endpoint Phase Status/Plan
Savolitinib + TAGRISSO SAFFRON: 2L/3L EGFRm, TAGRISSO refractory, MET amplified or overexpressed NSCLC (vs chemo); NCT05261399 PFS Global III Ongoing
Savolitinib + TAGRISSO SACHI: 2L EGFRm, EGFR TKI refractory, MET amplified NSCLC (vs chemo); NCT05015608 PFS China III NMPA approved in Jun 2025. Data at ASCO 2025. mPFS 8.2 vs 4.5 months (ITT, HR 0.34), 6.9 vs 3.0 months (post third-generation, HR 0.32) all p<0.0001, mOS 22.9 vs 17.7 months (ITT, HR 0.84, data immature), G 3 TRAE 45 vs 48%
Savolitinib + TAGRISSO SAVANNAH: 2L/3L EGFRm, TAGRISSO refractory, MET amplified or overexpressed NSCLC (single-arm); NCT03778229 ORR Global II Data at ELCC 2025. By investigator/BICR: ORR 56/55%, mPFS 7.4/7.5 months, mDoR 7.1/9.9 months, G 3 TEAE 57%
Savolitinib + TAGRISSO SANOVO: 1L EGFRm, MET overexpressed NSCLC (vs TAGRISSO ); NCT05009836 PFS China III Ongoing
Savolitinib monotherapy 1L/2L METex14 NSCLC (single-arm); NCT04923945 ORR China IIIb NMPA approved in Jan 2025; conditionally approved in 2021. Data at ELCC 2024 and 2025. 1L/2L: ORR 62.1/39.2%, mPFS 13.7/11.0 months, mOS 28.3/25.3 months, G 3 TEAE 62%
Savolitinib monotherapy 3L gastric cancer with MET amplified, two stages (single-arm); NCT04923932 ORR China II Registration twice-daily cohort LPI Apr 2025. Data at AACR 2023. 2L+ ORR 50%
Savolitinib + IMFINZI SAMETA: MET-driven PRCC (vs IMFINZI or SUTENT ); NCT05043090 PFS Global III Completed enrollment
For the first time, a China Phase II IIT study (FLOWERS, NCT05163249) of 1L MET amplified/overexpressed EGFRm NSCLC, comparing patients on savolitinib plus TAGRISSO vs. TAGRISSO alone, presented data at WCLC 2024, showing ORR of 90.5% vs. 60.9%, mPFS of 19.6 vs 9.3 months and mDoR of 18.6 vs 8.4 months. Our SANOVO China Phase III study plans to complete enrollment in the second half of 2025.
Commercial achievement: savolitinib in combination with TAGRISSO NMPA approval in June 2025 enabled savolitinib to potentially enter NRDL coverage negotiation this year.
Year Event
2025 Approved by the NMPA for MET amplification NSCLC after progression on 1L EGFR inhibitor therapy; Full approval by the NMPA for MET Exon 14 NSCLC (including 1L indication); Approved in Hong Kong under 1+ Mechanism
2023 NRDL inclusion (renewed in 2024)
2021 Conditional approval by the NMPA for advanced or metastatic 2L MET Exon 14 NSCLC and launched
2011 Worldwide license agreement with AstraZeneca
Fruquintinib (ELUNATE in China, FRUZAQLA outside of China)
Mechanism of action: fruquintinib is a selective oral inhibitor of VEGFR 1/2/3 kinases, designed to limit off-target kinase activity and improve drug exposure to achieve sustained target inhibition. Inhibition of the VEGFR can stop the growth of the vasculature around tumor and starve the tumor of nutrients and oxygen.
Target Indications: fruquintinib was approved and launched for 3L CRC in China in 2018 and approved in the US in 2023. According to Globocan, there were 517,000 new CRC cases in China (160,000 in the US, 540,000 in Europe and 146,000 in Japan) in 2022. About 15-20% of cases progress to 3L. The second approved indication of fruquintinib was in combination with TYVYT for the treatment of 2L EMC with pMMR status. According to Globocan, there were 78,000 new EMC cases in China in 2022. About 15-20% of cases experience recurrence. Third potential indication of fruquintinib in combination with TYVYT for 2L RCC is currently under NMPA review. According to Globocan, there were 74,000 new kidney cancer cases in China in 2022. About 90% are RCC and about 20-30% recur within the first five years.
Clinical development: FRUSICA-2 China Phase II/III study in combination with TYVYT for 2L RCC met primary endpoint of PFS in March 2025 and its NMPA filing was accepted in June 2025. We expect data from FRUSICA-2, an open-label, active-controlled study of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy, to be presented at ESMO Congress 2025.
Treatment Name: Indication (control); NCT# Endpoint Phase Status/Plan
Fruquintinib + TYVYT FRUSICA-2: 2L RCC (vs axitinib or everolimus); NCT05522231 PFS China II/III sNDA accepted by the NMPA in Jun 2025. Met primary endpoint.
Fruquintinib + TYVYT RCC (single-arm); NCT03903705 ORR China Ib/II Data in Targeted Oncology Jan 2025. 1L/2L: ORR 68.2/60.0%, mPFS not reached/15.9 months, OS 36m 72.4/58.3%, G 3 TRAE 52.4%
Fruquintinib + TYVYT FRUSICA-3: 2L pMMR EMC (vs paclitaxel or doxorubicin); NCT06584032 OS PFS China III FPI in Dec 2024
Fruquintinib + TYVYT FRUSICA-1: 2L+ pMMR EMC (single-arm); NCT03903705 ORR China II NMPA approved in Dec 2024. Data at ASCO 2024. ORR 35.6%, mPFS 9.5 months, mOS 21.3 months, G 3 TRAE 60.2%
Fruquintinib + TYVYT 3L+ CRC (single-arm); NCT03903705 ORR China Ib/II Data in European Journal of Cancer 2023. 5mg 2w/1w regimen pMMR: ORR 20.0%, mPFS 6.9 months, mOS 20.0 months, G 3 TRAE 47.7%
Fruquintinib monotherapy FRESCO-2: 3L+ CRC (vs placebo); NCT04322539 OS Global III FDA approved in 2023. Data at The Lancet 2023. mPFS 3.7/1.8 months (HR 0.32, p<0.001), mOS 7.4/4.8 months (HR 0.66, p<0.001), G 3 TRAE 62.7%
Fruquintinib monotherapy FRESCO: 3L CRC (vs placebo); NCT02314819 OS China III NMPA approved in 2018. Data at JAMA 2018. mPFS 3.7/1.8 months (HR 0.26, p<0.0001), mOS 9.3/6.6 months (HR 0.65, p<0.0001), G 3 TRAE 61.2%
For 3L CRC, an IIT China Phase II study in combination with TAS-102 (trifluridine/tipiracil hydrochloride) updated data at ASCO 2025 with mPFS of 6.3 months and mOS of 18.4 months, comparable to our previous Phase Ib/II study in combination with TYVYT , with mPFS of 6.9 months and mOS of 20.1 months, similar to or better than new modality in development.
Commercial achievement: for China, we launched second indication in 2L EMC, with average treatment duration almost twice that of 3L CRC and will work on NRDL coverage negotiation later this year. For overseas market, our partner Takeda targets over 20% sales growth for its fiscal year of 2025 (March 2026).
Year Event
2024 Conditional approval by NMPA for 2L pMMR EMC
2024 Approved for 3L+ CRC in the EU, Switzerland, Argentina, Canada, Japan, the UK, Australia, Singapore, Israel, UAE, South Korea; reimbursement in Spain and Japan
2024 Approved for 3L+ CRC in Hong Kong (first medicine to be approved under the new 1+ Mechanism, first innovative oncology medicine to be directly added for full reimbursement in the Hospital Authority Drug Formulary)
2023 FDA approval for 3L+ CRC in the US, inclusion in NCCN Clinical Practice Guidelines
2023 Exclusive worldwide license agreement with Takeda
2020 NRDL inclusion (renewed in 2022 and 2024)
2018 Approved for 3L+ CRC by the NMPA and launched
2013 License and collaboration agreement with Eli Lilly in China (as amended)
Surufatinib (SULANDA in China)
Mechanism of action: surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFR and FGFR, both involved in tumor angiogenesis, and CSF-1R, which regulates tumor-associated macrophages, promoting immune response against tumor cells. Its dual mechanism of action may be suitable for combinations with other immunotherapies, such as PD-1 antibodies.
Target indications: surufatinib was approved in China for non-pancreatic NETs in 2020 and for pancreatic NETs in 2021. There are approximately 40,000 new patients per year in China. Surufatinib is also being investigated in a Phase II/III study for 1L PDAC. PDAC is an aggressive form of cancer, representing over 90% of pancreatic cancer cases. According to Globocan, there were 119,000 new pancreatic cancer cases in China in 2022.
Clinical development: last patient was enrolled in November 2024 into the Phase II stage of a Phase II/III randomized, open-label trial to evaluate surufatinib combined with AiRuiKa , nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as a treatment 1L PDAC. We target data readout in the second half of 2025.
Treatment Name: Indication (control); NCT# Endpoint Phase Status/Plan
Surufatinib + AiRuiKa + chemo 1L PDAC (vs chemo); NCT06361888 OS China II/III Phase II LPI Nov 2024
Surufatinib monotherapy SANET-ep: epNET (vs placebo); NCT02588170 PFS China III NMPA approved in 2021. ORR 19.2 vs 1.9%, mPFS 10.9 vs 3.7 months (HR=0.49, p=0.001), G 3 TEAE 69.9 vs 27.1%
Surufatinib monotherapy SANET-p: pNET (vs placebo); NCT02589821 PFS China III NMPA approved in 2020. ORR 10.3 vs 0.0%, mPFS 9.2 vs 3.8 months (HR=0.33, p<0.0001), G 3 TEAE 76.7 vs 33.8%
Surufatinib monotherapy 2L+ pNET/epNET (single-arm); NCT02549937 PFS US/EU Ib Data at ASCO 2021. pNET/epNET: ORR 18.8/6.3%, mPFS 15.2/11.5 months, G 3 AE 75%
Surufatinib monotherapy pNET/epNET (single-arm); NCT02267967 ORR China Ib/II Data in Clinical Cancer Research 2019. pNET/epNET: ORR 19.0/15.0%, DCR 91.0/92.0%, mPFS 21.2/13.4 months, G 3 hypertension 33%
Updated clinical results of a Phase Ib/II IIT for 1L metastatic PDAC, in combination with AiRuiKa , chemotherapy nab-paclitaxel and S-1, were presented at ASCO 2025 showing ORR of 51.1% (vs 24.4% in chemotherapy control arm) and mPFS of 7.9 months (vs. 5.4 months) (NCT05218889).
Commercial achievement: surufatinib achieved market share of 27% in NETs treatment during the third quarter of 2024, ahead of competitors SUTENT and AFINITOR .
Year Event
2022 NRDL inclusion (renewed in 2024)
2021 Approved for pancreatic NETs by the NMPA and launched
2020 Approved for non-pancreatic NETs by the NMPA and launched
Sovleplenib (HMPL-523)
Mechanism of action: sovleplenib is a novel, selective, oral inhibitor targeting Syk. Syk is a kinase upstream to PI3K and BTK within the B-cell signaling pathway and a target for modulating B-cell signaling. We believe it could deliver the same outcome as inhibitors of BTK and PI3K . Its signaling processes do not only affect cells of immune responses but also in tissue pathology in autoimmune, inflammatory and allergic diseases.
Target indications: we are developing sovleplenib for ITP and wAIHA. ITP is an autoimmune disorder characterized by immunologic destruction of platelets and decreased platelet production, leading to increased risk of excessive bleeding and bruising. ITP is associated with fatigue (reported in up to 39% of adults with ITP) and impaired quality of life. As platelet destruction in ITP is mediated by Syk-dependent phagocytosis of Fc R-bound platelets, Syk inhibition is a promising approach to ITP management. According to IQVIA, China has 47,000 new ITP patients every year, on top of another 421,000 existing patients. About half of ITP patients cannot get satisfactory results from currently approved treatments such as TPO/TPO-RAs. NMPA has accepted our NDA filing for 2L ITP and we target re-submission in first half of 2026, with additional data rolling in during second half of 2026. In the future, the Company will look to continue overseas development.

Frequently Asked Questions

What were HUTCHMED's net income results for 2025?

HUTCHMED reported a net income of $455 million for 2025, primarily due to a non-core partial disposal.

What is the significance of the ATTC platform?

The ATTC platform enriches HUTCHMED's pipeline by enabling the development of innovative drug candidates.

How did sales perform for FRUZAQLA in H1 2025?

FRUZAQLA's sales increased by 25% to $162.8 million in the first half of 2025.

What clinical milestones did HUTCHMED achieve by mid-2025?

HUTCHMED achieved key milestones including the approval of ORPATHYS in China and positive trial results for ELUNATE.

What impact did market conditions have on HUTCHMED's sales?

HUTCHMED experienced a 4% decline in total in-market sales, largely due to competition and strategic changes.

Last updated: Aug 7, 2025