Kelun-Biotech Announce Exclusive License Agreement For SKB378/HBM9378, an Anti-thymic Stromal Lymphopoietin (TSLP) Monoclonal Antibody (mAb).

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that the Company and HBM Holdings Limited  ("Harbour BioMed") (together with the Company, the "Licensors"), have entered into an exclusive license agreement (the "License Agreement") with Windward Bio AG ("Windward Bio") for SKB378/HBM9378[1], an anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody (mAb) jointly developed by the Licensors.

Subject to the terms and conditions of the License Agreement, Windward Bio is granted an exclusive license for the research, development, manufacturing and commercialization of SKB378/HBM9378 globally (excluding Greater China and several Southeast and West Asian countries). In return, the Licensors are eligible to receive a total of up to US$970 million upfront and milestone payments as well as single to double-digit tiered royalties on net sales of SKB378/HBM9378. The US$45 million upfront and near-term payments include both cash consideration and equity in the parent company of Windward Bio. Subject to the terms and conditions of the License Agreement, the Licensors are also eligible to receive additional payment from Windward Bio if Windward Bio undergoes a near-term change of control or enters into a sublicense agreement with a third party. The payments to be made by Windward Bio to the Licensors under the License Agreement shall be paid in equal amounts to the Company and Harbour BioMed.

Windward Bio is a clinical-stage, drug development company committed to improving outcomes for people living with advanced immunological conditions with an initial focus on severe respiratory conditions. It is led by a highly experienced team of biopharmaceutical executives with deep discovery, development, and commercialization expertise, and is advancing a potential best-in-class TSLP monoclonal antibody into phase 2 development and creating novel, long-acting bispecific programs for immunological diseases. Collectively, they have contributed to more than 15 product launches and executed two Nasdaq IPOs and two sales.

In connection with the License Agreement, Windward Bio announced a US$200 million Series A financing round led by OrbiMed, Novo Holdings and Blue Owl Healthcare Opportunities with the co-investment of SR One, Omega Funds, RTW Investments, Qiming Venture Partners, Quan Capital, and Pivotal bioVenture Partners. 

Dr. Micheal Ge, CEO of Kelun-Biotech said, "We are pleased to have entered into a partnership with Windward Bio for the SKB378/HBM9378, one of our pioneering pipelines in immunology area, which is not only a proof of its potential market value globally, but also a practice of our active exploration of global cooperation. SKB378/HBM9378 is our first immunology product candidate out licensed with a NewCo model. In the future, we will continue to expand our global presence and strategic partnerships to maximize the value of our pipelines."

ABOUT SKB378/HBM9378

SKB378/HBM9378 is a co-development project jointly conducted by the Company and Harbour BioMed, with both parties equally sharing global rights. SKB378/HBM9378 is a novel, recombinant fully human monoclonal antibody (mAb) that potently binds to the TSLP ligand and inhibits the TSLP mediated signaling pathway by blocking the interaction between TSLP and TSLP receptor. This is a well-validated cytokine that plays a key role in the development and progression of a wide array of immunological conditions, including asthma and COPD where inhibition has demonstrated benefit in a wide array of inflammatory phenotypes. SKB378/HBM9378 has been engineered to achieve an extended half-life and effector silencing and is subcutaneously administered.

In November 2024, an IND application to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) was submitted for SKB378/HBM9378 for the treatment of chronic obstructive pulmonary disease (COPD). The Company has also completed phase 1 clinical trial in healthy subjects in China under IND approval from the NMPA for the treatment of moderate-to-severe asthma.

ABOUT KELUN-BIOTECH

Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 2 projects have been approved for marketing, 2 projects are in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/.

[1] SKB378 is known as HBM9378 in Harbour BioMed's pipeline and WIN378 in Windward Bio's pipeline.