Harbour BioMed Receives NMPA Clearance for COPD Treatment HBM9378/SKB378

Harbour BioMed Receives NMPA Clearance for COPD Treatment HBM9378/SKB378

China-based biopharmaceutical company Harbour BioMed (HKG: 2142) has announced receiving clinical clearance from China’s National Medical Products Administration (NMPA) for its investigational drug HBM9378/SKB378, also known as WIN378. This fully human antibody targets thymic stromal lymphopoietin (TSLP) and is intended for the treatment of chronic obstructive pulmonary disease (COPD).

Drug Development and Collaboration
HBM9378/SKB378 is co-developed by Harbour BioMed and Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with both parties equally sharing the rights to the drug in Greater China and several Southeast and West Asian countries. The drug is a fully human monoclonal antibody targeting TSLP, generated from the Harbour Mice platform (H2L2), which inhibits the TSLP-mediated signaling pathway by blocking the interaction between TSLP and its receptor.

Global Licensing Deal with Windward Bio
Last month, Harbour BioMed and Kelun-Biotech signed a USD 970 million global licensing deal with Windward Bio. Under the agreement, Harbour and Kelun-Biotech are eligible to receive USD 45 million in upfront and near-term milestone payments, including both cash and equity interest in Windward Bio’s parent company. Additionally, the companies will receive tiered royalties ranging from single to double digits on net sales. This deal underscores the potential of HBM9378/SKB378 in the global market for COPD treatments.-Fineline Info & Tech

Insight, China's Pharmaceutical Industry