SHANGHAI, October 14, 2021 - LaNova Medicines announced that the LM-302 antibody drug conjugate, one of LaNova's core products, has officially received the IND approval from China's NMPA. In June 2021, the project received the US FDA IND approval, and was granted FDA orphan drug qualification for treating pancreatic cancer, gastric cancer and gastroesophageal junction cancer. This study is a randomized, multi-center clinical trial designed to evaluate the safety and preliminary efficacy of LM-302.
About LM-302: This Claudin 18.2-targeting antibody-drug conjugate is a Class I new drug developed by LaNova Medicines, who owns the whole intellectual property rights and global rights. LM-302 is currently in Phase I clinical studies in China and the United States. LM-302 can specifically target Claudin 18.2-positive tumor cells and enter tumor cells through endocytosis, releasing small molecule toxins, thereby exerting potent anti-tumor effect. The preclinical research data of LM-302 showed good safety and activities both in vivo and in vitro, especially in tumor models with low Claudin 18.2 expression.
About LaNova Medicines: LaNova Medicines is a clinical stage biotech company founded by industry veterans. The company has the full-chain new drug research and development capabilities covering early research and development, translational medicine, and clinical development, and has received strong support from multiple leading investors. Based on its multiple R&D platforms, LaNova Medicines has created an innovative biologics drug pipeline with "first-in-class" and "best-in-class" potential, and has successfully advanced multiple innovative drug products into clinical stage in China, U.S. and Australia.