Core Viewpoint - China Biopharmaceutical's subsidiary, Lixin Pharmaceutical Technology, has successfully completed the first patient enrollment in the Phase I clinical trial of its innovative drug LM-350, marking the entry of this therapy into clinical development [1][2] Group 1: Product Development - LM-350 is a Class 1 innovative drug developed based on Lixin's next-generation ADC technology platform, targeting CDH17 with high selectivity and strong internalization capability [1] - The drug utilizes an IgG1 wild-type configuration and exhibits antibody-dependent cellular cytotoxicity (ADCC) activity [1] - Preclinical studies have shown significant anti-tumor activity of LM-350 in various xenograft models, particularly in colorectal cancer cells resistant to MMAE or irinotecan [1] Group 2: Clinical Need and Market Potential - CDH17 is highly expressed in approximately 99% of colorectal cancers, 86% of gastric adenocarcinomas, 79% of esophageal adenocarcinomas, and 50% of pancreatic ductal adenocarcinomas, indicating its critical role in tumor invasion and metastasis [1] - Gastrointestinal tumors, including colorectal, gastric, pancreatic, and esophageal cancers, represent one of the highest incidence and mortality rates globally, with over 4 million new patients reported in 2022, highlighting a significant unmet clinical need [1]
中国生物制药(01177):LM-350“CDH17 ADC”完成澳洲I期临床首例患者入组