Sino biopharmaceutical's LM-350 CDH17 ADC approved for clinical trial in China

Sino Biopharmaceutical Limited's wholly-owned subsidiary, LaNova Medicines Limited, has received clinical trial approval from China's National Medical Products Administration (NMPA) for LM-350, a CDH17 antibody-drug conjugate (ADC). This national Category 1 innovative drug, developed using LaNova Medicines' LM-ADC™ platform, targets CDH17 with high selectivity and strong internalization capabilities, demonstrating significant anti-tumor activity in preclinical studies. This was particularly notable in colorectal cancer models resistant to MMAE or Irinotecan.

LM-350 adopts a wild-type IgG1 configuration and exhibits antibody dependent cell-mediated cytotoxicity (ADCC) activity. CDH17, the target of LM-350, is highly expressed in various aggressive tumors, including approximately 99% of colon cancers, 86% of gastric adenocarcinomas, 79% of esophageal adenocarcinomas, and 50% of pancreatic ductal adenocarcinomas. Given that gastrointestinal tumors accounted for over 4 million new patients globally in 2022, this approval addresses substantial unmet clinical needs.

Previously, LM-350 received Investigational New Drug (IND) approval from the United States FDA and completed enrollment of the first patient in Australia in September 2025. With this new approval, LaNova Medicines plans to accelerate its clinical research within China, aiming to offer a novel treatment option to patients as quickly as possible.