Maiwei Biotech: Application for clinical trials of injection 7MW4911 accepted by the National Medical Products Administration and the US FDA.

On the evening of July 31, Miwei Biotechnology announced that the company has received a notification of acceptance from the National Medical Products Administration for the clinical trial application of injection 7MW4911. The company has also received an IND Acknowledgement Letter from the US Food and Drug Administration, confirming receipt of the company's IND application for injection 7MW4911. 7MW4911 is an innovative antibody-drug conjugate targeting cadherin-17 developed based on the company's proprietary IDDC antibody conjugation technology platform. CDH17, as a potential therapeutic target validated by pan-cancer multi-omics studies, is restricted to expression on the basolateral membrane of intestinal epithelial cells in normal tissues, while showing significant overexpression in digestive tract malignancies such as colorectal cancer, gastric cancer, and pancreatic cancer. Its abnormal high expression is closely related to tumor invasion, metastasis, and poor prognosis, providing an ideal target for precise intervention.