HUTCHMED (China) Limited (NASDAQ:HCM) on Tuesday shared data from the Phase 3 registration part of the ESLIM-02 clinical trial of sovleplenib in adult patients with warm antibody autoimmune hemolytic anemia (wAIHA).wAIHA is a condition where the immune system mistakenly makes IgG antibodies that attack and destroy red blood cells at normal body temperature, leading to anemia, fatigue, paleness, and shortness of breath.The trial conducted in China met its primary endpoint of durable hemoglobin (Hb) response ...

— Delivers rapid, durable responses in wAIHA, the more common form of this potentially life-threatening disease —  HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Jan. 07, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the Phase III registration part of the ESLIM-02 clinical trial of sovleplenib, a novel spleen tyrosine kinase (“Syk”) inhibitor, in adult patients with warm antibody autoimmune hemolytic anemia (“wAIHA”) in China has met its prim ...

Core Insights - HUTCHMED has introduced its innovative Antibody-Targeted Therapy Conjugate (ATTC) platform, which aims to redefine precision oncology through a dual-mechanism of action [1][2] - The lead candidate HMPL-A251, a selective PI3K/PIKK inhibitor, has shown promising preclinical efficacy and safety, positioning HUTCHMED's late-stage pipeline for further development [1][4] - The company is making significant progress in global and China trials, including studies for fruquintinib, surufatinib, and fanregratinib, enhancing its late-stage pipeline [1][9] ATTC Platform and Lead Candidate - The ATTC platform integrates monoclonal antibodies with small-molecule inhibitor payloads, providing synergistic anti-tumor activity and improved safety profiles compared to traditional antibody-drug conjugates [2][3] - HMPL-A251 is designed to target the PAM signaling pathway, which is often associated with poor prognosis in various cancers, and aims to enhance targeted delivery while minimizing systemic exposure [3][4] - Preclinical data indicates that HMPL-A251 exhibits strong anti-tumor activity, particularly in HER2-positive tumors, and shows potential for improved efficacy compared to existing therapies like trastuzumab deruxtecan [4][5] Clinical Development Plans - HUTCHMED plans to advance HMPL-A251 into clinical development in late 2025, focusing on various cancer types with different HER2 and PAM alteration statuses [5] - The company aims to explore a broader range of antibody selections and payload options to enhance treatment outcomes and overcome resistance [6] Late-stage Program Updates - The company reported significant progress in late-stage programs, including the FRUSICA-2 study for fruquintinib, which demonstrated a progression-free survival of 22.2 months compared to 6.9 months with standard treatments [9] - Recruitment for the SANOVO study in first-line EGFR-mutated non-small cell lung cancer has been completed, with further studies for surufatinib and fanregratinib also advancing [9]

Summary of HUTCHMED (HCM) Conference Call Company Overview - **Company**: HUTCHMED (HCM) - **Industry**: Biotechnology and Pharmaceuticals Key Points Financial Performance - **1H25 Earnings Results**: Total topline revenue of $277.7 million, which is -13% and -18% below Goldman Sachs estimates of $337.8 million and Visible Alpha consensus of $318.1 million respectively [1][4] - **Earnings per Share (EPS)**: Reported at $0.52, significantly above estimates due to a one-time gain of $477.5 million from reducing stake in SHPL from 45% to 5% [1][4] - **Revenue Guidance**: FY25 consolidated oncology revenue guidance reduced to $270 million - $350 million from $350 million - $450 million [1][4] Market Dynamics - **Challenges in China**: Increased competition for core products (Elunate, Sulanda, Orpathys) and regulatory changes affecting sales and marketing teams [1][4] - **Sales Performance**: - **Elunate**: Sales decreased by -29% year-over-year due to competition and generics [4] - **Sulanda**: Sales decreased by -50% attributed to competition from new somatostatin analogue drugs [4] - **Orpathys**: Sales declined by -41% due to competing drugs being added to the National Reimbursement Drug List (NRDL) [4] - **Fruzaqla Growth**: Sales increased by 25% outside China, primarily driven by market expansion in Europe and Japan, though growth in the US was moderate due to competition [1][4] Pipeline and Future Outlook - **Sovleplenib**: NDA re-submission delayed; targeting re-submission in 1H26 [5] - **Savolitinib**: Enrollment ongoing in Phase 3 SAFFRON study, potential for global regulatory filings if successful [5] - **ATTC Platform**: New antibody-targeted therapy conjugates platform with preclinical data expected later this year, initial partner responses are positive [6] Model Adjustments - **Revenue Estimates**: Adjustments made to reflect 1H25 actuals and increased competition, leading to lower near-term revenue estimates [8] - **2025 Estimates**: Revenue revised down to $583.3 million from $688.3 million, reflecting a -15.3% change [9] Valuation and Risks - **Price Target**: Maintained at $18 for ADR listed in the US, with a 12-month upside of 10.4% [12][14] - **Key Risks**: Include clinical success/failure, regulatory risks, financial risks under HFCAA, and potential for better-than-expected commercial sales [12] Conclusion - **Investment Rating**: Neutral, with ongoing monitoring of pipeline progress and commercial recovery potential in China [1][12]