Hutchmed Receives Priority Review for Fanregratinib NDA Targeting Advanced Cholangiocarcinoma
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 29 2025
0mins
Should l Buy HCM?
Source: NASDAQ.COM
- NDA Progress: Hutchmed's fanregratinib (HMPL-453) has received priority review from the China National Medical Products Administration, targeting adult patients with advanced cholangiocarcinoma who have previously undergone systemic therapy, indicating the company's proactive stance in innovative drug development.
- Clinical Study Support: The NDA is backed by data from a single-arm, multi-center, open-label Phase II registration study in China, which achieved its primary endpoint of objective response rate, demonstrating the drug's efficacy in treatment.
- Significant Market Potential: Cholangiocarcinoma accounts for 8.2%-15.0% of primary liver cancers and generally has poorer prognosis, making the successful launch of fanregratinib a vital new treatment option for patients and potentially capturing substantial market share for the company.
- Future Plans: Hutchmed intends to present full study results at an upcoming scientific conference, further validating the drug's efficacy and safety, which could enhance investor confidence and drive the company's stock price upward.
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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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- 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.
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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.
- 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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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.
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See More
