Huadong Pharmaceutical (000963.SZ): The application for clinical trial of HDM2012 injectable drugs has been approved by the US FDA

Zhitong Finance App News, Huadong Pharmaceutical (000963.SZ) issued an announcement. On June 28, 2025, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as “Sino-US Huadong”), a wholly-owned subsidiary of the company, received a notice from the US Food and Drug Administration (hereinafter referred to as “US FDA”). The clinical trial application for injectable HDM2012 drugs declared by China and US Huadong has been approved by the US FDA. The indications are advanced solid tumors.

HDM2012 for injection is a novel antibody-drug conjugate (ADC) targeting human mucin-17 (Mucin 17, MUC-17) independently developed by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (Huadong, China). It is formed by coupling an anti-MUC-17 monoclonal antibody with a topoisomerase I inhibitor through a lyzable ligand. The drug antibody coupling ratio (DAR) is 8. This product is the world's first Class 1 biological product, and East China and East China have global intellectual property rights. HDM2012 specifically identifies tumor surface antigens expressed positively by MUC-17 through the targeted action of antibodies. Using the internalization effect mediated by target antigens, ADCs enter tumor cells, break the ligands, release toxins, and exert anti-tumor effects. At the same time, the bystander effect of HDM2012 also exerts a certain degree of tumor killing effect. Pre-clinical study results show that HDM2012 has good pharmacogenicity, safety and efficacy. HDM2012 showed excellent anti-tumor effects in multiple tumor models; it was well tolerated in animal tests.