HUTCHMED Reports Phase 3 Data for Sovleplenib, Plans NDA Submission in 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 07 2026
0mins
Source: Benzinga
- 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.
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Analyst Views on HCM
Wall Street analysts forecast HCM stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for HCM is 22.00 USD with a low forecast of 22.00 USD and a high forecast of 22.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 15.220
Low
22.00
Averages
22.00
High
22.00
Current: 15.220
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.
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.
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HUTCHMED and AstraZeneca's Drug Approved, PFS Increased to 8.2 Months
- 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.
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