Harbour BioMed's HBM9378/SKB378: A Promising TSLP-Targeted Therapy for Immunological Diseases

Harbour BioMed (HKEX: 02142), a global biopharmaceutical company specializing in immune-oncology and immunology, recently announced a license agreement with Windward Bio AG for HBM9378/SKB378, an anti-thymic stromal lymphopoietin (TSLP) fully human monoclonal antibody. This collaboration highlights the potential of HBM9378/SKB378 in addressing immunological diseases, with a focus on asthma and chronic obstructive pulmonary disease (COPD).

HBM9378/SKB378, developed jointly by Harbour BioMed and Sichuan Kelun Biotech BioPharmaceutical (HKEX: 06990), targets TSLP, a well-validated cytokine playing a key role in the development and progression of various immunological conditions. The antibody inhibits the TSLP-mediated signaling pathway by blocking the interaction between TSLP and its receptor, demonstrating benefits across multiple inflammatory phenotypes. Its long half-life optimization and outstanding biophysical properties provide a favorable dosing advantage.

Prior to the license agreement, Harbour BioMed submitted an Investigational New Drug (IND) application to the Centre for Drug Evaluation of the National Medical Products Administration (NMPA) in China for HBM9378/SKB378 for the treatment of COPD in November 2024. The company has also completed a phase I clinical trial in China under an IND for the treatment of moderate-to-severe asthma.

Windward Bio, a clinical-stage drug development company focused on improving outcomes for people living with advanced immunological conditions, will lead the development and commercialization of HBM9378/SKB378 globally, excluding Greater China and several Southeast and West Asian countries. In return, Harbour BioMed and Kelun-Biotech are eligible to receive a total of up to $970 million in upfront and milestone payments, as well as tiered royalties ranging from single to double digits on net sales. The $45 million upfront and near-term milestone payments include both cash payment and an equity interest in Windward Bio's parent company.

Windward Bio announced a $200 million Series A financing round led by OrbiMed, Novo Holdings, and Blue Owl Healthcare Opportunities, along with co-investors SR One, Omega Funds, RTW Investments, Qiming Venture Partners, Quan Capital, and Pivotal bioVenture Partners. This financing round reflects the market's confidence in HBM9378/SKB378's potential and Windward Bio's ability to develop and commercialize innovative therapies.