HUTCHMED Submits NDA for Savolitinib in Gastric Cancer with Priority Review Granted
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 30 2025
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Should l Buy HCM?
Source: Newsfilter
- NDA Approval: HUTCHMED's New Drug Application (NDA) for savolitinib targeting MET-amplified gastric cancer patients has been accepted and granted priority review by the China National Medical Products Administration, marking a significant advancement for the drug in the Chinese market.
- Clinical Data Support: This application is backed by a single-arm, multi-center, open-label Phase II registration study conducted in China, which demonstrated that savolitinib achieved its primary endpoint of objective response rate (ORR) in MET-amplified gastric cancer patients, indicating its therapeutic potential.
- Strong Market Demand: With an estimated annual incidence of approximately 18,000 cases of MET-amplified gastric cancer in China and a poor prognosis associated with this type, the introduction of savolitinib is expected to provide a new treatment option in a high-demand market, potentially significantly improving patient survival rates.
- Strategic Importance: The granting of Breakthrough Therapy Designation to savolitinib in 2023 highlights its substantial advantages in treating serious conditions, further solidifying HUTCHMED's leadership position in the Chinese biopharmaceutical market.
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Analyst Views on HCM
Wall Street analysts forecast HCM stock price to rise
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Current: 14.750
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Current: 14.750
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About HCM
HUTCHMED (China) Ltd is an investment holding company principally engaged in the manufacture and sale of pharmaceuticals. The Company operates its business through two segments. Oncology Immunology segment is engaged in the discovery, development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Among it, research and development (R&D) includes research and development activities covering drug discovery, development, manufacturing and regulatory functions, out-licensing of in-house developed drugs, as well as administrative activities to support research and development operations, marketed products comprises the invoiced sales, marketing, manufacture and distribution of drugs developed from research and development activities. Other Ventures segment is engaged in the other commercial businesses which include the sales, marketing, manufacture and distribution of other prescription drugs and healthcare products.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Webcast Presentations: The management will host two webcasts on the same day for analysts and investors to discuss the final results and conduct Q&A sessions, enhancing transparency and investor relations.
- Multilingual Support: The English webcast is scheduled for March 5 at 8:00 am EST, while the Chinese webcast will take place on March 6 at 8:30 am HKT, ensuring participation from investors in different languages.
- Company Background: HUTCHMED is an innovative, commercial-stage biopharmaceutical company focused on targeted therapies and immunotherapies for cancer and immunological diseases, committed to bringing drug candidates from in-house discovery to the global market.
See More
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See More
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See More
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See More
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- Earnings Announcement Schedule: HUTCHMED will announce its final results for the year ended December 31, 2025, on March 5, 2026, at 6:00 am EST, marking a critical moment for the company's annual performance.
- Webcast Presentations: The management will host two webcasts on the same day for analysts and investors to discuss the final results and conduct Q&A sessions, enhancing transparency and investor relations.
- Multilingual Support: The English webcast is scheduled for March 5 at 8:00 am EST, while the Chinese webcast will take place on March 6 at 8:30 am HKT, ensuring participation from investors in different languages.
- Company Background: HUTCHMED is an innovative, commercial-stage biopharmaceutical company focused on targeted therapies and immunotherapies for cancer and immunological diseases, committed to bringing drug candidates from in-house discovery to the global market.
See More
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- Regulatory Approval Milestone: The combination received regulatory approval in China in June 2025, marking a significant milestone in HUTCHMED's collaboration with AstraZeneca, which is expected to drive sales growth in the Chinese market.
- Patient Benefits: The combination offers a convenient and well-tolerated all-oral treatment option for patients previously treated with third-generation EGFR TKIs, addressing the needs of this underserved population and enhancing treatment adherence.
- Safety Profile Analysis: Although 57% of patients in the savolitinib and osimertinib group experienced grade 3 or higher adverse events, this was comparable to the chemotherapy group, indicating a favorable safety and tolerability profile for future clinical applications.
See More
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- Regulatory Approval Milestone: Based on interim data from the SACHI trial, the savolitinib and osimertinib combination received regulatory approval in China in June 2025, marking a significant milestone in clinical application and expected to enhance patient survival rates.
- Significant Patient Benefits: Among 211 participants, the objective response rate (ORR) for the savolitinib and osimertinib group was 58%, compared to only 34% in the chemotherapy group, showcasing the combination's substantial advantage in improving treatment outcomes and potentially altering patient treatment options.
- Good Safety Profile: The combination exhibited an acceptable safety profile, with 57% of patients experiencing grade 3 or higher adverse events, comparable to the chemotherapy group, indicating that this treatment regimen has good tolerability for broader application.
See More
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- Clinical Trial Progress: The approval supports the company's competitiveness in the global market, as Glatiramer Acetate remains a key product despite revenue erosion from generics, highlighting its ongoing relevance in the biotech sector.
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See More
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- Significant Market Potential: With an annual incidence rate of 0.8-3.0 per 100,000 adults and accounting for 75-80% of all adult autoimmune hemolytic anemia cases, sovleplenib presents a substantial opportunity in the treatment market.
- NDA Submission Plans: HUTCHMED plans to submit a New Drug Application for sovleplenib to the China National Medical Products Administration in the first half of 2026, enhancing its competitive edge and expanding its product portfolio.
- Competitive Landscape Analysis: In December 2025, Novartis's ianalumab combination therapy demonstrated significant treatment efficacy, prompting HUTCHMED to expedite the market introduction of sovleplenib to navigate the increasingly competitive environment.
See More
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- Positive Efficacy Data: The Phase II study in January 2025 showed an overall response rate of 66.7% for sovleplenib compared to 0% for placebo, not only proving its efficacy but also laying a solid foundation for future market promotion.
- New Drug Application Plans: HUTCHMED plans to submit a New Drug Application for sovleplenib to the China National Medical Products Administration in the first half of 2026, which is expected to further enhance the company's strategic positioning in the biopharmaceutical sector.
- Positive Stock Reaction: HUTCHMED's stock rose 12.51% to $15.47 in the latest trading session, reflecting market optimism regarding its clinical progress, potentially providing support for future financing and R&D efforts.
See More
