Huadong Medicine: HDM2012 for injection obtains drug clinical trial approval notice
2025-07-18 15:48:30

Huadong Medicine announced that its wholly-owned subsidiary Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. received the "Notice of Approval for Drug Clinical Trial" issued by the State Drug Administration, and the clinical trial application for HDM2012 for injection submitted by Zhongmei Huadong was approved. HDM2012 for injection is a new antibody-drug conjugate (ADC) targeting human mucin-17 (MUC-17) independently developed by Zhongmei Huadong. It is a monoclonal antibody against MUC-17 and a topoisomerase I inhibitor conjugated by a cleavable linker, with a drug-antibody conjugate ratio (DAR) of 8. This product is a world-first Class 1 biological product, and Zhongmei Huadong owns global intellectual property rights. HDM2012 specifically recognizes MUC-17 positively expressed tumor surface antigens through the targeting effect of antibodies, and uses target antigen-mediated internalization to allow ADC to enter the tumor cells. The linker breaks and releases the toxin drug to exert an anti-tumor effect. At the same time, the bystander effect of HDM2012 also exerts a certain degree of tumor killing effect. Preclinical research results show that HDM2012 has good drugability, safety and effectiveness.
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