East China Pharmaceutical: Injection HDM2012 has obtained the drug clinical trial approval notification.
East China Medicine announced that its wholly-owned subsidiary Hangzhou Zhongmei East China Pharmaceutical Co., Ltd. has received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration, approving the clinical trial application for the injectable HDM2012 submitted by Zhongmei East China. Injectable HDM2012 is a novel antibody-drug conjugate targeting human mucin-17 developed independently by Zhongmei East China, consisting of a monoclonal antibody against MUC-17 and a topoisomerase I inhibitor linked by a cleavable linker, with a drug-antibody ratio of 8. This product is classified as a type 1 biologic globally, and Zhongmei East China holds global intellectual property rights. HDM2012 specifically recognizes tumor surface antigen MUC-17 positive expression through the targeted action of antibodies, enters tumor cells through antigen-mediated internalization, releases toxin small molecules by linker cleavage, and exerts antitumor effects. Meanwhile, HDM2012 demonstrates bystander effects to a certain extent in killing tumors. Preclinical study results have shown that HDM2012 has good drugability, safety, and effectiveness.
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