By Fineline Cube 
Sino Biopharmaceutical Ltd (HKG: 1177) announced that it has obtained Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for its LM-108, a CCR8-targeted monoclonal antibody (mAb) co-developed with LaNova Medicines. The designation covers the use of LM-108 in combination with toripalimab for CCR8-positive advanced gastric/gastroesophageal junction (G/GEJ) adenocarcinoma patients who have failed first-line standard therapy.
Drug Mechanism
LM-108, developed using LaNova’s proprietary GPCR antibody discovery platform, is an Fc-optimized humanized mAb. It depletes regulatory T cells (Tregs) in the tumor microenvironment via antibody-dependent cellular cytotoxicity (ADCC). This mechanism has the potential to overcome PD-1/PD-L1 resistance by enhancing anti-tumor immunity.
Clinical Data
Phase I/II clinical data demonstrated that LM-108 in combination with a PD-1 antibody achieved an objective response rate (ORR) of 36.1% in gastric cancer patients, rising to 87.5% in the CCR8 high expression subgroup. In pancreatic cancer patients, the combination therapy achieved an ORR of 20.3%, with a median total survival of 10.02 months and an ORR of 33.3% in the overexpression subgroup.
Regulatory and Development Milestones
LM-108 previously received BTD in February 2025 for MSI-H/dMMR advanced solid tumors. The drug has now initiated pivotal Phase II regulatory clinical trials, supported by its demonstrated efficacy in various gastrointestinal tumors.-Fineline Info & Tech