HUTCHMED (00013) Initiates Global Study of KRAS-EGFR Antibody-Drug Conjugate Therapy HMPL-A830 for the Treatment of Solid Tumors

HUTCHMED (00013) announces the initiation of the Phase Ia portion of a global clinical trial of HMPL-A830 for the treatment of unresectable advanced or metastatic solid tumors. The first patient received their first dose in China on September 24, 2026. Antibody-targeted conjugate (ATTC) drugs use antibody-guided delivery to enable potent, cell-killing targeted payloads to concentrate on and exert activity within tumor tissue. This first-in-class ATTC candidate is composed of a highly selective, potent KRAS (Kirsten rat sarcoma) small molecule inhibitor as the payload, conjugated to an anti-epidermal growth factor receptor (EGFR) antibody. Colorectal cancer, pancreatic cancer, and lung cancer are the cancer types with the highest incidence of KRAS gene alterations, and these patients often lack safe and durable KRAS therapies. HMPL-A830 is designed to address this need by delivering the KRAS inhibitor directly to EGFR-expressing tumors, simultaneously blocking both EGFR and KRAS signaling pathways, thereby improving efficacy, durability, and tolerability. This first-in-human trial is a Phase I, open-label, multicenter clinical study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of HMPL-A830. The study includes a Phase Ia dose-escalation stage to determine the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE). A subsequent dose-expansion/optimization stage will further evaluate the safety, tolerability, and preliminary antitumor activity of HMPL-A830 in selected solid tumors. Further details of the study can be found at clinicaltrials.gov under registration number NCT07718581. On September 3, 2026, the Company's subsidiary HUTCHMED Limited and a subsidiary of GSK plc ("GlaxoSmithKline") entered into an exclusive development and license agreement granting the GSK subsidiary the rights to develop and commercialize HMPL-A830 worldwide outside of mainland China, Hong Kong, Macau, and Taiwan. HUTCHMED Limited will be responsible for the global Phase I development program of HMPL-A830. The GSK subsidiary will be responsible for all subsequent clinical development and commercialization activities outside of mainland China, Hong Kong, Macau, and Taiwan. The agreement's effectiveness is subject to the satisfaction of customary closing conditions, including completion of relevant antitrust regulatory review.