Welcome to our dedicated page for Hutchmed (China) news (Ticker: HCM), a resource for investors and traders seeking the latest updates and insights on Hutchmed (China) stock.
HUTCHMED (China) Limited (HCM) news covers the company’s ongoing work as a commercial-stage biopharmaceutical developer of targeted therapies and immunotherapies for cancer and immunological diseases. Press releases frequently describe progress across its in-house pipeline, regulatory milestones in China and abroad, and updates on marketed medicines such as ELUNATE® (fruquintinib), ORPATHYS® (savolitinib) and SULANDA® (surufatinib).
Investors and healthcare professionals following HUTCHMED news can expect detailed reports on clinical trial results, including Phase II and Phase III data in solid tumors and autoimmune hematologic diseases. Recent announcements have highlighted Phase III outcomes for savolitinib plus TAGRISSO® in EGFR-mutated non-small cell lung cancer, topline Phase III results for sovleplenib in warm antibody autoimmune hemolytic anemia, and initiation or expansion of studies such as the Phase II/III trial of surufatinib and camrelizumab in metastatic pancreatic ductal adenocarcinoma.
News items also address regulatory and reimbursement developments, such as New Drug Application acceptances with priority review for savolitinib in MET-amplified gastric cancer and fanregratinib in intrahepatic cholangiocarcinoma, as well as inclusion of HUTCHMED-associated medicines on China’s National Reimbursement Drug List and the National Commercial Health Insurance Innovative Drug List. These updates provide context on how the company’s therapies may reach broader patient populations.
Another recurring theme is platform and pipeline strategy, including announcements about the ATTC (Antibody-Targeted Therapy Conjugate) platform and first-in-human trials of HMPL-A251, as well as presentations at major scientific meetings such as ESMO, ASH and AACR-NCI-EORTC. For those tracking HCM, this news feed offers a centralized view of clinical data readouts, partnership activities, regulatory interactions and broader R&D progress. Bookmarking this page allows readers to follow how HUTCHMED’s oncology and immunology programs evolve over time.
HUTCHMED (Nasdaq/AIM: HCM) highlighted that results from the randomized Phase III SACHI trial were published in The Lancet on Jan 14, 2026, confirming efficacy of MET inhibition in advanced EGFR‑mutant NSCLC with acquired MET amplification after progression on prior EGFR‑TKI therapy.
The trial evaluated the oral combination of savolitinib (ORPATHYS) plus osimertinib (TAGRISSO). Based on interim SACHI data, the savolitinib+osimertinib combination received regulatory approval in China in June 2025. The program is jointly developed by AstraZeneca and HUTCHMED.
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) announced that the Phase III registration part of the ESLIM-02 trial of sovleplenib, a Syk inhibitor for adult warm antibody autoimmune hemolytic anemia (wAIHA) in China, met its primary endpoint of durable hemoglobin response during weeks 5–24.
The randomized, double‑blind, placebo‑controlled study enrolled patients with primary or secondary wAIHA who relapsed or were refractory to ≥1 prior standard therapy. Earlier Phase II data reported overall response 43.8% vs 0% at 8 weeks and 66.7% at 24 weeks for sovleplenib with a favourable safety profile. HUTCHMED plans to submit a NDA to NMPA in H1 2026. Full ESLIM-02 results will be presented at an upcoming scientific conference.
HUTCHMED (Nasdaq/AIM: HCM) has initiated the Phase III portion of its Phase II/III trial evaluating surufatinib + camrelizumab + nab-paclitaxel + gemcitabine (S+C+AG) as first-line treatment for metastatic pancreatic ductal adenocarcinoma in China, with the first patient dosed on Dec 30, 2025.
The Phase III plans ~400 additional patients (62 in Phase II). Primary endpoint is overall survival (OS). Phase II results showed median PFS 7.20 vs 5.52 months (HR 0.499, p=0.0407), ORR 67.7% vs 41.9% (p=0.0430) and DCR 93.5% vs 71.0% (p=0.0149). OS was immature (not reached vs 8.48 months, unstratified HR 0.555). Safety: grade ≥3 TEAEs 80.6% vs 61.3%.
HUTCHMED (Nasdaq/AIM: HCM) announced that the China NMPA accepted the NDA for savolitinib to treat locally advanced or metastatic gastric cancer/gastroesophageal junction adenocarcinoma with MET amplification and granted priority review on Dec 30, 2025.
The NDA is supported by a single-arm, multi-center Phase II registration study in Chinese patients that met its primary endpoint of objective response rate (ORR) by IRC (RECIST 1.1). Savolitinib previously received Breakthrough Therapy designation in 2023. MET amplification is estimated at 4–6% of gastric cancer cases, with an annual incidence of roughly 18,000 patients in China.
HUTCHMED (Nasdaq/AIM: HCM) announced that the New Drug Application for fanregratinib (HMPL-453) in second-line intrahepatic cholangiocarcinoma (ICC) with FGFR2 fusion/rearrangement has been accepted and granted priority review by the China NMPA on Dec 29, 2025. Fanregratinib is an oral selective FGFR 1/2/3 inhibitor.
The NDA is supported by a single-arm, multi-center Phase II registration study in China (clinicaltrials.gov identifier NCT04353375) that met its primary endpoint of objective response rate; secondary endpoints (PFS, DCR, DoR, OS) also supported the primary findings. ICC accounts for roughly 8.2–15.0% of primary liver cancers and has an approximate 5-year overall survival of 9%; ~10–15% of ICC tumors harbor FGFR2 fusions/rearrangements.
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.
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