Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (Kelun-Biotech) and HBM Holdings Limited (Harbour BioMed) have entered into an exclusive license agreement with Windward Bio AG for SKB378/HBM9378, an anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody. This agreement allows Windward Bio to exclusively research, develop, manufacture, and commercialize SKB378/HBM9378 worldwide, with the exception of Greater China and several Southeast and West Asian countries.
Under the terms of the agreement, Kelun-Biotech and Harbour BioMed are set to receive up to US$970 million in upfront and milestone payments, along with single to double-digit tiered royalties on net sales of SKB378/HBM9378. This includes an initial US$45 million in upfront and near-term payments, comprising both cash and equity in Windward Bio's parent company. Additionally, the licensors may receive further payments if Windward Bio undergoes a change of control or enters into a sublicense agreement with a third party.
Windward Bio, a clinical-stage drug development company, focuses on improving outcomes for individuals with advanced immunological conditions, particularly severe respiratory conditions. The company is advancing SKB378/HBM9378, a potential best-in-class TSLP monoclonal antibody, into phase 2 development. Windward Bio also announced a US$200 million Series A financing round led by prominent investment firms.
SKB378/HBM9378 is a novel, recombinant fully human monoclonal antibody that targets the TSLP ligand, inhibiting the TSLP-mediated signaling pathway. This mechanism is crucial in the development and progression of various immunological conditions, including asthma and COPD. The antibody has been engineered for an extended half-life and is administered subcutaneously.
In November 2024, an IND application for SKB378/HBM9378 was submitted to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of chronic obstructive pulmonary disease (COPD). Kelun-Biotech has also completed a phase 1 clinical trial in healthy subjects in China for the treatment of moderate-to-severe asthma under IND approval from the NMPA.
Kelun-Biotech, a subsidiary of Kelun Pharmaceutical, specializes in the R&D, manufacturing, and commercialization of innovative biological and small molecule drugs. The company is focused on addressing unmet medical needs in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, aiming to become a leading global enterprise in the field of innovative drugs.
