LM-302 (CLDN18.2 ADC), a class 1 new drug, has again been granted Breakthrough Therapy designation, demonstrating global advancement in research and development

CAR-T Digest - August 2020

Weekly Digest - August 2025

19 August 2025: LM-302 (CLDN18.2 ADC), a class 1 new drug, has again been granted Breakthrough Therapy designation, demonstrating global advancement in research and development

Lixin Pharmaceuticals LM-302 (CLDN18.2 ADC), a wholly owned subsidiary of Sino Biopharmaceutical, has again received Breakthrough Therapy Designation from China’s NMPA for first-line treatment of CLDN18.2-positive gastric and gastroesophageal junction adenocarcinoma in combination with toripalimab
LM-302 has previously secured FDA IND and Orphan Drug Designations for gastric, pancreatic, and biliary cancers, highlighting its global development progress as a potential first-in-class ADC
At ASCO 2025, LM-302 plus toripalimab showed strong efficacy in gastric cancer patients, with an ORR of 65.9% and DCR of 85.4% overall, and even higher responses in patients with CLDN18.2 ≥25% and across PD-L1 subgroups
The drug is now in Phase 3 trials in China for advanced or metastatic gastric/GEJ cancer after at least two prior lines and is among the top three CLDN18.2-targeted ADCs globally
Developed through Lixin’s proprietary LM-ADC platform, LM-302 reflects Sino Biopharma’s broader innovation strategy, which includes multiple antibody and immune engager platforms