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HCMHUTCHMED (China) Limited American Depositary Shares

HCM

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HC

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HUTCHMED Announces Submission of US NDA for ORPATHYS® plus TAGRISSO® in MET-Driven EGFR-Mutated Lung CancerHUTCHMED announced that AstraZeneca has submitted a New Drug Application (NDA) to the FDA for ORPATHYS® (savolitinib) combined with TAGRISSO® (osimertinib) to treat patients with MET-driven EGFR-mutated non-small cell lung cancer who progressed on EGFR-TKI therapy. The submission is supported by the SAFFRON Phase III trial, which demonstrated statistically significant improvements in progression-free survival and overall survival compared to platinum-based chemotherapy.GlobeNewswire Inc. · Sep 29, 2026

HUTCHMED Initiates Global Trial of KRAS-EGFR-Antibody Conjugate Therapy HMPL-A830 in Patients with Solid TumorsHUTCHMED has initiated a Phase Ia global clinical trial of HMPL-A830, a first-in-class antibody-targeted therapy conjugate combining a KRAS inhibitor with an anti-EGFR antibody for treating solid tumors. The first patient was dosed on September 24, 2026. HUTCHMED entered an exclusive development and licensing agreement with GSK on September 3, 2026, granting GSK worldwide rights (excluding Greater China) for development and commercialization.GlobeNewswire Inc. · Sep 28, 2026

HUTCHMED Highlights Clinical Data to be Presented at the ESMO Congress 2026HUTCHMED announced that two Phase III studies evaluating the savolitinib and osimertinib combination for non-small cell lung cancer will be presented at ESMO Congress 2026 in Madrid. The SAFFRON global study and SANOVO China study both demonstrated statistically significant and clinically meaningful improvements in progression-free survival and overall survival compared to chemotherapy and osimertinib monotherapy, respectively. The all-oral, chemo-free combination has been selected for high-profile oral presentations including a Presidential Symposium.GlobeNewswire Inc. · Sep 24, 2026

AZN's Tagrisso Plus Orpathys Study in First-Line NSCLC Meets GoalAstraZeneca announced positive Phase III SANOVO study results showing that Tagrisso (osimertinib) combined with Orpathys (savolitinib) significantly improved progression-free survival versus Tagrisso monotherapy in treatment-naïve patients with EGFR-mutated advanced NSCLC with MET overexpression. The combination also demonstrated encouraging overall survival improvements. These results could expand the clinical utility of the combination to first-line treatment settings.Zacks Investment Research · Sep 2, 2026

HUTCHMED Announces SANOVO Trial Demonstrated Significant Progression-Free Survival Benefit of ORPATHYS® Plus TAGRISSO® in Treatment-Naïve Patients with MET-Overexpressing EGFR-mutated Lung Cancer in ChinaHUTCHMED announced positive Phase III SANOVO trial results showing that ORPATHYS® (savolitinib) combined with TAGRISSO® (osimertinib) demonstrated statistically significant progression-free survival improvements and encouraging overall survival benefits in treatment-naïve patients with MET-overexpressing EGFR-mutated NSCLC in China, extending the clinical value of the combination into the first-line setting.GlobeNewswire Inc. · Aug 31, 2026

HUTCHMED Announces NMPA Approval for ATLED® (Fanregratinib) for the Treatment of Patients with FGFR2-Fusion/Rearrangement Intrahepatic CholangiocarcinomaHUTCHMED received conditional approval from China's NMPA for ATLED® (fanregratinib), a selective FGFR 1/2/3 inhibitor, for treating advanced intrahepatic cholangiocarcinoma with FGFR2 fusions/rearrangements in previously treated patients. The Phase II trial demonstrated an objective response rate of 42.5%, median PFS of 6.9 months, and median OS of 16.6 months, addressing a significant therapeutic gap in this aggressive cancer type.GlobeNewswire Inc. · Aug 28, 2026

HUTCHMED Highlights Pivotal Phase II Data for Fanregratinib in Intrahepatic Cholangiocarcinoma Presented at ESMO Gastrointestinal Cancers Congress 2026HUTCHMED announced positive Phase II pivotal trial results for fanregratinib (HMPL-453) in treating advanced intrahepatic cholangiocarcinoma patients with FGFR2 fusion/rearrangement. The study achieved a 42.5% objective response rate, 6.9-month median duration of response, and 16.6-month median overall survival, with a manageable safety profile. The company received priority review status from China's NMPA for a New Drug Application in December 2025.GlobeNewswire Inc. · Jun 25, 2026

HUTCHMED Highlights Sovleplenib ESLIM-02 Phase III Data in Warm Antibody Autoimmune Hemolytic Anemia Presented at EHA 2026 CongressHUTCHMED announced positive Phase III results for sovleplenib (HMPL-523) in treating warm antibody autoimmune hemolytic anemia (wAIHA). The drug demonstrated a 66% durable response rate versus 15% for placebo and showed rapid hemoglobin response with a favorable safety profile. China's NMPA accepted the New Drug Application for priority review in April 2026 and previously granted Breakthrough Therapy Designation in March 2026.GlobeNewswire Inc. · Jun 12, 2026

Johnson & Johnson Hits Target With IMAAVY In Rare Blood DisorderJohnson & Johnson announced that IMAAVY (nipocalimab-aahu) achieved its primary endpoint in the Phase 2/3 ENERGY study for warm autoimmune hemolytic anemia (wAIHA). Patients receiving the 30 mg/kg dose were three times more likely to achieve durable hemoglobin improvements compared to placebo over 24 weeks. The drug demonstrated rapid onset of effect, early improvements in fatigue, and reduced steroid use, with a safety profile consistent with its approved indication in myasthenia gravis. The supplemental Biologics License Application has been granted FDA Priority Review.Benzinga · Jun 11, 2026

HUTCHMED Highlights Data to be Presented at AACR Annual Meeting 2026HUTCHMED announced that new and updated data from several studies will be presented at the AACR Annual Meeting 2026 in San Diego. Preclinical data for HMPL-A580, a first-in-class PI3K/PIKK-EGFR Antibody-Targeted Therapy Conjugate, showed robust anti-tumor effects with excellent selectivity and favorable pharmacokinetic properties. Updated results from Phase Ib/II trials of surufatinib combined with other therapies for small bowel adenocarcinoma, appendiceal carcinoma, and pancreatic ductal adenocarcinoma will also be presented.GlobeNewswire Inc. · Apr 9, 2026

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