HUTCHMED Showcases HMPL-A251 Findings at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Treatments
Introduction of HMPL-A251: HUTCHMED announced HMPL-A251, a first-in-class PI3K/AKT/mTOR-HER2 Antibody-Targeted Therapy Conjugate (ATTC), designed to enhance targeted therapy while reducing toxicity, with promising preclinical data presented at a major cancer conference.
Mechanism and Efficacy: The ATTC combines a potent PI3K/PIKK inhibitor with an anti-HER2 antibody, demonstrating robust antitumor activity across various cancer cell lines, including HER2-positive and HER2-low models, while also showing a bystander effect on HER2-null cells.
Safety and Tolerability: HMPL-A251 is engineered to minimize toxicity associated with traditional cytotoxic payloads, achieving superior efficacy and tolerability compared to standalone therapies and traditional antibody-drug conjugates.
Future Development Plans: HUTCHMED plans to initiate global clinical trials for HMPL-A251 by the end of 2025, with additional Investigational New Drug filings for more ATTC candidates expected in 2026, aiming to redefine treatment options for various cancers.
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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.

- 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.
- 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.

- 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.
- 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.

- 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.





