Hutchmed (China) Limited Stock Price, News & Analysis

HUTCHMED (NASDAQ/AIM: HCM) initiated global Phase I/IIa clinical development of HMPL-A251, the first clinical candidate from its next-generation ATTC platform. The first patient was dosed in China on Dec 16, 2025, with study sites in the US and China and registry identifier NCT07228247. HMPL-A251 is a HER2-targeted Antibody-Targeted Therapy Conjugate carrying a highly selective PI3K/PIKK inhibitor payload via a cleavable linker. The open-label study will evaluate safety, tolerability, MTD/RDE, and preliminary efficacy, plus pharmacokinetics and immunogenicity in HER2-expressing solid tumors.

Preclinical data were presented at the 2025 AACR-NCI-EORTC conference.

HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) announced that following NHSA contract renewal the updated National Reimbursement Drug List (NRDL) effective Jan 1, 2026 will continue to include ELUNATE, ORPATHYS and SULANDA. In addition, TAZVERIK is included in the first edition of China’s National Commercial Health Insurance Innovative Drug List.

Indications listed: ELUNATE for advanced endometrial cancer (pMMR) in combination with TYVYT and metastatic colorectal cancer; ORPATHYS for NSCLC with MET exon 14 skipping; SULANDA for progressive non-functional well-differentiated NETs; TAZVERIK for relapsed/refractory follicular lymphoma with EZH2 mutation after ≥2 prior therapies. The Commercial Insurance Drug List enables reimbursement via commercial plans, expanding patient access to these oncology treatments.

HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) announced new and updated clinical data to be presented at the ESMO Asia Congress (Dec 5-7, 2025, Singapore) and the ASH Annual Meeting (Dec 6-9, 2025, Orlando). Presentations include first-in-human results for the anti-CD47 antibody HMPL-A83, phase II data from the FRUSICA-2 study of fruquintinib+sintilimab in second-line renal cell carcinoma, and phase II results for surufatinib+camrelizumab+chemotherapy in first-line metastatic pancreatic cancer. The company will also present investigator-initiated study updates and the final analysis of the phase 3 ESLIM-01 sovleplenib study in chronic primary immune thrombocytopenia.

HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) announced completion of enrollment in SAFFRON, a global Phase III trial of ORPATHYS (savolitinib) plus TAGRISSO (osimertinib) for EGFR‑mutated, MET‑overexpressed and/or amplified locally advanced or metastatic NSCLC after progression on TAGRISSO. The last patient was randomized on October 31, 2025. The randomized study enrolled 338 patients across >230 sites in 29 countries and uses BICR‑assessed PFS (RECIST 1.1) as the primary endpoint. Topline results are estimated in H1 2026; favorable data could support global regulatory filings. ORPATHYS received approval in China in June 2025 based on SACHI Phase III results.

HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) presented R&D and business updates on Oct 31, 2025, spotlighting a new Antibody-Targeted Therapy Conjugate (ATTC) platform and late-stage pipeline progress.

The lead ATTC candidate HMPL-A251 (PAM-HER2) showed superior preclinical efficacy and tolerability versus separate components and benchmark ADC T-DXd, and is planned to enter clinical development in late 2025. Key late-stage results: FRUSICA-2 (fruquintinib+sintilimab) reported PFS 22.2 vs 6.9 months (HR 0.37; p<0.0001) and ORR 60.5% vs 24.3%. Multiple registrational studies and regulatory filings are on track through H1–Q2 2026.

HUTCHMED (Nasdaq/AIM: HCM) presented preclinical data for HMPL-A251 at the AACR-NCI-EORTC conference (Oct 22–26, 2025). HMPL-A251 is an ATTC combining a humanized anti-HER2 IgG1 with a highly potent, selective PI3K/PIKK inhibitor payload via a cleavable hydrophilic linker. In vitro it showed broad activity across 130 tumor cell lines, HER2-dependent killing and a bystander effect. In vivo a single IV dose induced tumor regression across HER2-positive and HER2-low models, with efficacy comparable or superior to T-DXd in most models. Free payload plasma exposure was very low (mass ratio <1:500,000). Global clinical trials are planned around end of 2025 with additional IND filings in 2026.

HUTCHMED (Nasdaq/AIM: HCM, HKEX: 13) appointed Professor Tan Shao Weng, Daniel as an Independent Non-executive Director and member of its Technical Committee effective 15 October 2025.

Professor Tan, age 47, brings >20 years in oncology, leads the NCCS Experimental Cancer Therapeutics Unit (running ~30–40 Phase I trials), and is principal investigator on an NMRC Lung Cancer grant (2025–2029). His annual director fees are US$76,000 plus US$8,000 for committee membership. The appointment term runs to the next AGM and then on successive 12‑month terms, subject to re‑election and company articles.

HUTCHMED (Nasdaq/AIM: HCM) reported Phase III FRUSICA-2 results for the fruquintinib plus sintilimab combination in second-line advanced renal cell carcinoma, to be presented at ESMO on Oct 17, 2025.

Key outcomes at PFS cutoff Feb 17, 2025: median PFS 22.2 months vs 6.9 months (HR 0.373, p<0.0001); ORR 60.5% vs 24.3% (OR 4.622, p<0.0001); median DoR 23.7 vs 11.3 months. Overall survival data remain immature (~20% mature). The safety profile was tolerable with grade ≥3 TEAEs 71.4% vs 58.8%. An NDA has been accepted by China NMPA for review.

HUTCHMED (NASDAQ/AIM:HCM) has announced multiple data presentations at the upcoming ESMO Congress 2025 in Berlin, Germany. The highlight will be the presentation of results from the FRUSICA-2 registration study examining fruquintinib and sintilimab combination as second-line treatment for renal cell carcinoma in a Mini Oral session.

Additional presentations include analyses of the FRUSICA-1 study in endometrial cancer and the SAVANNAH and SACHI studies in non-small cell lung cancer. The congress will feature both company-sponsored and investigator-initiated studies across multiple cancer types, including colorectal, gastric, lung, and pancreatic cancers, showcasing HUTCHMED's expanding oncology portfolio.