East China Pharmaceuticals (000963.SZ): The clinical trial application for injectable drug HDM2024 has been approved by the US FDA.

Huadong Medicine (000963.SZ) announced on March 10, 2026, that its wholly-owned subsidiary Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as "Zhongmei Huadong") has received a notification from the U.S. Food and Drug Administration (FDA) that the clinical trial application for the injectable drug HDM2024 submitted by Zhongmei Huadong has been approved by the FDA for Phase I clinical trials in the United States for the treatment of advanced solid tumors. Injectable HDM2024 is a first-class biopharmaceutical developed and owned globally by Zhongmei Huadong. It is a novel bispecific antibody-drug conjugate (Bs-ADC) targeting epidermal growth factor receptor 1 (EGFR/HER1) and human epidermal receptor 3 (HER3). HDM2024 consists of a dual antibody molecule targeting EGFR/HER3, a cleavable linker, and a DNA topoisomerase 1 inhibitor cytotoxic molecule. HDM2024 can simultaneously block the EGFR/HER3 signaling pathway, effectively inhibit tumor cell proliferation signals, and release toxin payloads into tumor cells to exert anticancer effects. Preclinical studies have demonstrated that HDM2024 exhibits strong anticancer activity in various solid tumor efficacy models with different levels of target expression, and has good drug-like properties and safety.