IND approval for LM-350 “CDH17 ADC” from the US FDA

CAR-T Digest - August 2020

24 July 2025: IND approval for LM-350 “CDH17 ADC” from the US FDA

Sino Biopharmaceutical’s subsidiary, LaNova Medicines, has received the green light from the U.S. FDA to begin clinical trials of LM-350, a promising new antibody-drug conjugate (ADC) that targets CDH17
LM-350, based on LaNova’s next-gen LM-ADC platform, uses a wild-type IgG1 structure with ADCC activity and shows strong internalization and high selectivity for CDH17
Preclinical studies demonstrated potent anti-tumor efficacy of LM-350 in multiple xenograft models, particularly in colorectal cancer resistant to MMAE or irinotecan
With this approval, LM-350 becomes the latest addition to the group’s growing ADC pipeline, which now includes five clinical-stage candidates and nearly ten more in preclinical development, many of which are expected to enter trials in the next year or two