LaNova Medicines Announces IND Approval of LM-350 by NMPA

Shanghai, November 17, 2025 - LaNova Medicines Ltd. announced that the investigational new drug (IND) of LM-350, an innovative antibody-drug conjugate (ADC) targeting CDH17, has been approved by China NMPA. 

LM-350 was developed using LaNova's next-generation ADC platform, LM-ADC™. It is a highly selective ADC that targets cadherin-17 (CDH17) with strong internalization capacity. The molecule features a wild-type IgG1 backbone and retains antibody-dependent cell-mediated cytotoxicity (ADCC) activity. In preclinical studies, LM-350 demonstrated potent anti-tumor efficacy across multiple xenograft models, with particularly strong activity in colorectal cancer cells resistant to MMAE or irinotecan.

CDH17 plays a key role in tumor invasion and metastasis and is highly expressed in approximately 99% of colorectal cancers, 86% of gastric adenocarcinomas, 79% of esophageal adenocarcinomas, and 50% of pancreatic ductal adenocarcinomas.Gastrointestinal (GI) cancers—including colorectal, gastric, pancreatic, and esophageal cancers—are among the most prevalent and deadly cancer types worldwide. In 2022, global incidence exceeded 4 million cases, underscoring the significant unmet medical need in this area.

Previously, LM-350 received FDA IND approval and completed first-patient-dosed in Australia in September 2025. With the approval of the China IND, LaNova will further accelerate the clinical development of LM-350 in China, striving to bring this new treatment option to patients as soon as possible.