HUTCHMED (China) (HCM) Status update summary

Strategic partnership and transaction overview

• Entered a global licensing and co-development agreement (excluding Mainland China, Hong Kong, Macau, Taiwan) with GSK for HMPL-A830, a first-in-class KRAS-EGFR antibody-targeted therapy conjugate (ATTC), with a total deal size up to $1.3 billion, including $110 million upfront and tiered royalties on ex-China sales.

• HUTCHMED retains full development and commercialization rights in Mainland China, Hong Kong, Macau, and Taiwan, while GSK will handle subsequent clinical development and commercialization elsewhere.

• GSK also secured a right of first negotiation for another early-stage ATTC candidate, reflecting ongoing multinational interest in the platform.

• The partnership validates the ATTC platform, accelerates global development, and marks the first global licensing to a multinational pharma company.

• HUTCHMED will lead global phase I trials, with GSK taking over ex-China development post-phase I.

Scientific and clinical development insights

• HMPL-A830 is a novel small molecule KRAS inhibitor payload conjugated to an EGFR antibody, designed for dual inhibition to improve efficacy and safety, and to overcome resistance from EGFR upregulation.

• The dual targeting strategy addresses acquired resistance mechanisms and broadens potential indications across major solid tumors, including colorectal, pancreatic, and lung cancers.

• Phase I trials will enroll patients with KRAS mutations across major tumor types, with initial trials expected to start in H2 2026 and plans to move into combination studies and frontline settings.

• The ATTC platform is advancing additional programs targeting PI3K/PIKK pathways, including assets like HMPL-A251 and HMPL-A580, both in global Phase I trials.

• The platform leverages AI to generate multiple drug candidates annually, supporting ongoing innovation and expansion.

Financial and commercial highlights

• The agreement includes $110 million upfront, up to $1.3 billion in potential milestone payments, and tiered royalties on ex-China sales (9%-13%) and 30% on China sales.

• HUTCHMED will receive milestone and royalty income from both the GSK deal and existing partnerships, including AstraZeneca for China indications.

• Recent positive phase III readouts from the SAFFRON and SANOVO studies support global and China expansion, with both studies meeting PFS and OS endpoints.

• The company anticipates presenting detailed data at upcoming academic conferences.