Sino Biopharm's LM-108 receives new breakthrough therapy designation

Sino Biopharmaceutical (HKEX:1177) announced that its LM-108, jointly developed with LaNova Medicines, has been granted Breakthrough Therapy Designation (BTD) by China's Center for Drug Evaluation (CDE) for use in combination with toripalimab to treat CCR8-positive advanced gastric/gastroesophageal junction (G/GEJ) adenocarcinoma in patients who have failed first-line therapy. This marks the second BTD for LM-108, following a previous designation for advanced solid tumors with microsatellite instability high (MSI-H) or deficient mismatch repair (dMMR). Clinical data presented at the 2024 ASCO Annual Meeting demonstrated a 36.1% objective response rate (ORR) and a 72.2% disease control rate (DCR) for LM-108 in combination with a PD-1 monoclonal antibody in advanced G/GEJ adenocarcinoma patients. Furthermore, the ORR reached 87.5% in the CCR8 high-expression subgroup. The company is also exploring combination therapies for LM-108 in additional tumor types.