HUTCHMED Secures Priority Review for Fanregratinib NDA in China
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 29 2025
0mins
Should l Buy HCM?
Source: NASDAQ.COM
- New Drug Application Progress: HUTCHMED's Fanregratinib NDA has received priority review from China's NMPA, targeting adult patients with advanced intrahepatic cholangiocarcinoma who have previously undergone systemic therapy, showcasing the company's ongoing innovation in cancer treatment.
- Clinical Research Support: The NDA is backed by a multi-center, open-label Phase 2 study conducted in China that met its primary endpoint of objective response rate, indicating the drug's potential in treating intrahepatic cholangiocarcinoma and possibly generating new revenue streams for the company.
- Market Outlook Analysis: Intrahepatic cholangiocarcinoma accounts for 8.2%-15% of primary liver cancers globally, with FGFR2 rearrangements occurring in 10%-15% of cases, providing a solid foundation for Fanregratinib's market acceptance and enhancing HUTCHMED's competitive position in the oncology drug market.
- Financial Overview: HUTCHMED reported total consolidated revenue of $277.7 million for the first half of 2025, down from $305.7 million in the same period of 2024, yet the company holds $1.36 billion in cash and short-term investments, ensuring robust funding for future R&D initiatives.
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Analyst Views on HCM
Wall Street analysts forecast HCM stock price to rise
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 14.750
Low
22.00
Averages
22.00
High
22.00
Current: 14.750
Low
22.00
Averages
22.00
High
22.00
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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- 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.
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See More
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- 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.
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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
HUTCHMED and AstraZeneca's MET Inhibitor Approved, PFS Improved to 8.2 Months
- Clinical Trial Results: HUTCHMED's SACHI Phase III trial demonstrated that the combination of savolitinib and osimertinib resulted in a median progression-free survival (PFS) of 8.2 months for patients with EGFR mutations and MET amplification, significantly outperforming the chemotherapy group's 4.5 months, indicating the combination's potential in treating resistant tumors.
- 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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- Clinical Trial Results: HUTCHMED's SACHI Phase III trial demonstrated that the combination of savolitinib and osimertinib achieved a median progression-free survival (PFS) of 8.2 months in patients with EGFR mutations and MET amplification, significantly outperforming the chemotherapy group's 4.5 months, indicating the combination's potential in treating resistant tumors.
- 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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- FDA Approval: ScinoPharm Taiwan (TWSE:1789) received FDA approval for its Glatiramer Acetate Injection for treating adult multiple sclerosis patients, marking the company's first finished drug approval and paving the way for regulatory submissions in Europe and Asia for broader commercialization.
- Market Reaction: Following this announcement, ScinoPharm's stock price rose by 3.08% to NT$23.40 on January 8, 2025, reflecting positive market sentiment regarding the product's prospects.
- 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.
- Strategic Positioning: This approval not only strengthens ScinoPharm's position in the biopharmaceutical landscape but also lays the groundwork for future market expansions, demonstrating the company's commitment to innovative drug development.
See More
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- Clinical Trial Success: HUTCHMED's ESLIM-02 trial in China successfully met its primary endpoint, demonstrating durable hemoglobin response rates for sovleplenib in treating adult warm antibody autoimmune hemolytic anemia, marking a significant advancement in this therapeutic area.
- 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
HUTCHMED's ESLIM-02 Trial Meets Primary Endpoint; NDA Submission Planned for 2026
- Clinical Trial Success: HUTCHMED's ESLIM-02 clinical trial's Phase III registration part successfully met its primary endpoint in China, demonstrating durable hemoglobin response rates within weeks 5 to 24, marking a significant advancement in the treatment of autoimmune hemolytic anemia.
- 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
