Zhi Tong Cai Jing·2025-11-18 09:41Core Viewpoint - China National Pharmaceutical Group's subsidiary, Lixin Pharmaceutical Technology (Shanghai) Co., Ltd., has received clinical trial approval from the National Medical Products Administration (NMPA) for its self-developed innovative drug LM-350, a CDH17 antibody-drug conjugate (ADC) [1][2] Group 1: Product Development - LM-350 is developed based on Lixin's next-generation LM-ADC platform, specifically 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 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 patients reported in 2022, indicating a significant unmet clinical need [1] Group 3: Regulatory Progress - LM-350 has previously received an Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) and is set to complete its first patient enrollment in Australia by September 2025 [2] - With the approval of the clinical trial application in China, Lixin Pharmaceutical aims to accelerate clinical research in China to provide new treatment options for patients as soon as possible [2]