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.

HUTCHMED has initiated a Phase I/IIa clinical trial of HMPL-A580, its second novel Antibody-Targeted Therapy Conjugate (ATTC), in patients with unresectable, advanced or metastatic solid tumors across China and the US. The first-in-class candidate combines a PI3K/PIKK inhibitor payload with an anti-EGFR antibody to deliver dual mechanisms of action, with preclinical data showing synergistic anti-tumor activity.

HUTCHMED (China) Limited will announce its 2025 final results on March 5, 2026, with webcast presentations in English and Chinese. The company has published Phase III SACHI trial results confirming MET inhibition efficacy in advanced NSCLC patients and announced positive Phase III results for sovleplenib in treating warm antibody autoimmune hemolytic anemia.

The SACHI Phase III trial demonstrated that the combination of savolitinib (ORPATHYS®) and osimertinib (TAGRISSO®) significantly improved progression-free survival (8.2 vs 4.5 months) compared to chemotherapy in patients with EGFR-mutated NSCLC with MET amplification after EGFR-TKI progression. The combination was approved in China in June 2025 and results were published in The Lancet.

HUTCHMED announced positive Phase III topline results for sovleplenib in treating warm antibody autoimmune hemolytic anemia (wAIHA) in China, meeting its primary endpoint of durable hemoglobin response rate. The company plans to submit a New Drug Application to China's NMPA in the first half of 2026. Phase II results showed a 43.8% response rate versus 0% for placebo in the first 8 weeks.

HUTCHMED has initiated the Phase III portion of a Phase II/III trial evaluating the combination of surufatinib, camrelizumab, nab-paclitaxel, and gemcitabine for treatment-naïve metastatic pancreatic ductal adenocarcinoma in China. Phase II results showed the combination achieved a median PFS of 7.20 months versus 5.52 months for chemotherapy alone, representing a 50.1% reduction in progression or death risk, with a favorable overall survival trend.

HUTCHMED announced that its New Drug Application (NDA) for fanregratinib (HMPL-453) has been accepted with priority review status by China's NMPA for treating advanced intrahepatic cholangiocarcinoma (ICC) with FGFR2 fusion/rearrangement. The NDA is supported by a Phase II registration trial in China that met its primary endpoint of objective response rate, with positive secondary endpoints including progression-free survival, disease control rate, duration of response, and overall survival.