Harbour BioMed (HKEX: 02142, the "Company"), a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on immune-oncology and immunology, today announced that the National Medical Products Administration (NMPA) of China has approved the Investigational New Drug (IND) application for HBM9378/SKB378 (also known as WIN378), a fully human antibody targeting thymic stromal lymphopoietin (TSLP), for the treatment of chronic obstructive pulmonary disease (COPD).

COPD is a progressive respiratory condition with major complications, including cardiovascular risk, respiratory failure, and lung cancer. The disease imposes a significant and growing burden both in terms of healthcare costs and societal impact. There is an urgent need for new therapeutic options to alleviate the daily suffering of COPD patients and improve their quality of life.

TSLP plays a critical role in triggering airway inflammation by activating immune responses that contribute to COPD progression. HBM9378/SKB378 is designed to inhibit the TSLP-mediated signaling pathway, aiming to reduce airway inflammation and improve lung function in patients with COPD.

"This regulatory clearance from the NMPA marks an important milestone in advancing our efforts to address significant unmet needs in immunological diseases," said Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed. "HBM9378/SKB378 represents a potential best-in-class, long-acting TSLP antibody with exceptional biophysical properties. We will continue exploring its therapeutic potential to benefit patients worldwide."

On January 10, 2025, Harbour BioMed and Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech") entered into a global licensing agreement (excluding Greater China and select Southeast and West Asian countries) with Windward Bio for HBM9378/SKB378. Under the terms of the agreement, Harbour BioMed and Kelun-Biotech are eligible to receive $45 million in upfront and near-term milestone payments, including both cash and equity interest in Windward Bio's parent company. The total potential deal value, including upfront and milestone payments, could reach up to $970 million, in addition to tiered royalties ranging from single to double digits on net sales.