HUTCHMED 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.

HUTCHMED 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.

HUTCHMED 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.

AstraZeneca 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.

HUTCHMED 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.

HUTCHMED 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.

HUTCHMED 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.

HUTCHMED 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.

Johnson & 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.

HUTCHMED 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.

HUTCHMED has initiated a Phase III clinical trial of HMPL-760 combined with R-GemOx in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in China. The trial will enroll approximately 240 patients and follows encouraging Phase II results showing improvements in overall response rate, complete response rate, progression-free survival, and overall survival with a manageable safety profile.

HUTCHMED announces that Professor Mok Shu Kam, Tony will retire as Independent Non-executive Director at the May 12, 2026 AGM after serving for over eight years, approaching the nine-year tenure cap under Hong Kong Listing Rules. Following his retirement, Dr Renu Bhatia will become Senior and Lead Independent Non-executive Director, Dr Chaohong Hu will chair the Technical Committee, and Professor Tan Shao Weng, Daniel will join the Sustainability Committee.