Harbour BioMed's HBM9378/SKB378 Approved for COPD Treatment

Harbour BioMed has received approval from China’s National Medical Products Administration (NMPA) for the Investigational New Drug (IND) application of HBM9378/SKB378 (WIN378).

HBM9378/SKB378 is a monoclonal antibody co-developed by Harbour BioMed and Kelun-Biotech. Both companies share rights to the treatment in Greater China and several Southeast and West Asian countries. 

The antibody, generated using the Harbour Mice® H2L2 platform, blocks the interaction between TSLP and its receptor. Since TSLP is associated with multiple inflammatory conditions, including asthma and COPD, its inhibition has demonstrated benefits across different inflammatory profiles.

This fully human antibody targets thymic stromal lymphopoietin (TSLP) and is intended for the treatment of chronic obstructive pulmonary disease (COPD).

COPD is a progressive respiratory condition that can lead to serious complications such as cardiovascular disease, respiratory failure, and lung cancer. 

The disease places a significant burden on healthcare systems and society, creating an urgent need for new treatments to improve patients’ quality of life.

TSLP is known to play a key role in airway inflammation by triggering immune responses that contribute to COPD progression. HBM9378/SKB378 is designed to inhibit this signalling pathway, aiming to reduce inflammation and improve lung function.

Earlier this year, Harbour BioMed and Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (Kelun-Biotech) signed a global licensing agreement with Windward Bio, covering territories outside Greater China and selected countries in Southeast and West Asia. 

Under this agreement, Harbour BioMed and Kelun-Biotech are set to receive an initial payment of $45 million, including both cash and equity in Windward Bio’s parent company. The overall value of the deal could reach $970 million, with additional milestone payments and tiered royalties on net sales.

HBM9378/SKB378 has undergone a Phase I clinical trial in China under an IND for moderate-to-severe asthma, and a Phase II trial for this indication is expected to commence soon.

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