智通财经网·2025-11-18 09:43Core Viewpoint - China National Pharmaceutical Group's subsidiary, Lixin Pharmaceutical Technology, has received clinical trial approval from the NMPA for its innovative drug LM-350, a CDH17-targeted antibody-drug conjugate (ADC) [1][2] Group 1: Product Development - LM-350 is developed based on Lixin's next-generation LM-ADC™ platform and selectively binds to CDH17, demonstrating strong internalization capabilities [1] - The drug utilizes an IgG1 wild-type configuration and exhibits antibody-dependent cellular cytotoxicity (ADCC) activity [1] - Preclinical studies show significant anti-tumor activity of LM-350 in various xenograft models, particularly in colorectal cancer models resistant to MMAE or irinotecan [1] Group 2: Market Potential - CDH17 is highly expressed in various cancers, including approximately 99% in colorectal cancer, 86% in gastric adenocarcinoma, 79% in esophageal adenocarcinoma, and 50% in pancreatic ductal adenocarcinoma [1] - Gastrointestinal cancers, including colorectal, gastric, pancreatic, and esophageal cancers, represent one of the highest incidence and mortality rates globally, with over 4 million new cases reported in 2022, indicating a significant unmet clinical need [1] Group 3: Regulatory Progress - LM-350 has previously received IND approval from the FDA, with the first patient enrollment in Australia expected by September 2025 [2] - The approval of the clinical trial application in China will accelerate the clinical research process, aiming to provide new treatment options for patients sooner [2]