HUTCHMED Highlights Sovleplenib ESLIM-02 Phase III Data in Warm Antibody Autoimmune Hemolytic Anemia Presented at EHA 2026 Congress

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.

06/11/2026, 8:00 PM • GlobeNewswire

Johnson & Johnson Hits Target With IMAAVY In Rare Blood Disorder

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.

06/11/2026, 12:40 PM • Benzinga

HUTCHMED Highlights Data to be Presented at AACR Annual Meeting 2026

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.

04/08/2026, 8:00 PM • GlobeNewswire

HUTCHMED Initiates Phase III Trial of HMPL-760 in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma in China

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.

03/22/2026, 8:00 PM • GlobeNewswire

Intended Retirement of Independent Non-executive Director and changes of composition of board committees

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.

03/06/2026, 3:30 AM • GlobeNewswire

HUTCHMED Initiates Global Trial of PI3K/PIKK-EGFR ATTC Candidate HMPL-A580 in Patients with Solid Tumors

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.

03/04/2026, 3:30 AM • GlobeNewswire

HUTCHMED to Announce 2025 Final Results

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.

02/06/2026, 3:30 AM • GlobeNewswire

HUTCHMED Highlights Publication of Phase III SACHI Results in The Lancet

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.

01/13/2026, 11:00 PM • GlobeNewswire

HUTCHMED Announces Positive Topline Results of Phase III Part of ESLIM-02 Trial of Sovleplenib for Warm Antibody Autoimmune Hemolytic Anemia in China

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.

01/06/2026, 7:00 PM • GlobeNewswire

HUTCHMED Initiates Phase III Stage of the Ongoing Trial of the Combination of Surufatinib and Camrelizumab for Treatment-Naïve Pancreatic Ductal Adenocarcinoma

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.

01/04/2026, 7:00 PM • GlobeNewswire

HUTCHMED Announces NDA Acceptance in China with Priority Review Status for Fanregratinib in Second-Line Intrahepatic Cholangiocarcinoma

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.

12/29/2025, 3:35 AM • GlobeNewswire

BTK Inhibitors Clinical Trial Pipeline Accelerates as 30+ Pharma Companies Rigorously Develop Drugs for Market Entry | DelveInsight

Over 30 pharmaceutical companies are developing BTK inhibitors targeting B-cell cancers, autoimmune disorders, and neurological conditions, with promising pipeline drugs in various clinical trial stages.

12/17/2025, 1:00 PM • GlobeNewswire

HUTCHMED Initiates Global Clinical Development of ATTC Candidate HMPL-A251 in Patients with Solid Tumors

HUTCHMED launched a global Phase I/IIa clinical trial for HMPL-A251, a novel antibody-targeted therapy conjugate (ATTC) designed to treat HER2-expressing solid tumors with potentially improved safety and efficacy.

12/16/2025, 7:00 PM • GlobeNewswire

Acute Myeloid Leukemia Clinical Trial Pipeline Appears Robust With 100+ Key Pharma Companies Actively Working in the Domain | DelveInsight

Over 100 pharmaceutical companies are actively developing 150+ pipeline drugs for Acute Myeloid Leukemia (AML), with approximately 10 drugs in late-stage development and 50+ in mid and early stages, focusing on targeted therapies and personalized treatment approaches.

12/04/2025, 1:00 PM • GlobeNewswire

HUTCHMED Highlights Clinical Data to be Presented at the 2025 ESMO Asia Congress and the 2025 ASH Annual Meeting

HUTCHMED will present clinical data on multiple compounds at two major medical conferences, including studies on fruquintinib, HMPL-A83, savolitinib, surufatinib, and sovleplenib across various cancer and medical conditions.

11/26/2025, 7:00 PM • GlobeNewswire