Taizhou-based monoclonal antibody (mAb) biosimilars specialist MabPharm Ltd (HKG: 2181) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study of its Category 1 innovative drug candidate CMAB017 in advanced solid tumors. The trial will include patients with colorectal cancer, head and neck squamous cell carcinoma, and esophageal squamous cell carcinoma, among others.
Drug Profile
CMAB017 is an innovative anti-EGFR antibody. The blocking peptide design of CMAB017 is expected to significantly reduce the adverse reactions of skin and digestive tract mucosa. The selection of the IgG1 constant region can enhance the effect mediated by the Fc segment of the antibody, thereby improving the efficacy. Animal experiments showed that CMAB017 locally accumulated in tumors 24 to 72 hours after administration. Compared with similar products already on the market, CMAB017 has better efficacy and safety.
Future Plans
MabPharm is expected to initiate a Phase III clinical study for the drug during the fourth quarter of 2024 and obtain market approval during the fourth quarter of 2027.-Fineline Info & Tech