#China #Chengdu #Kelun-Biotech #Windward Bio #TSLP Antibody

Strategic Licensing Agreement Between Kelun-Biotech and Windward Bio

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. has announced a significant partnership with Windward Bio AG, regarding the licensing of their jointly developed monoclonal antibody, SKB378/HBM9378. This innovative therapy targets anti-thymic stromal lymphopoietin (TSLP) and aims to address severe respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD).

The Agreement in Detail

Under this exclusive license agreement, Windward Bio will oversee the global research, development, manufacturing, and commercialization of SKB378/HBM9378, barring Greater China and certain Southeast and Western Asian markets. The agreement specifies that Kelun-Biotech and Harbour BioMed, the other licensor, stand to gain up to $970 million through upfront payments, milestone bonuses, and tiered royalties based on net sales

The initial payment includes a combination of cash and equity stakes in Windward Bio, totaling $45 million. Payments are structured to be shared equally between Kelun-Biotech and Harbour BioMed.

In the event of Windward Bio's corporate restructuring or if they enter a sublicense deal with third parties, the licensors may receive additional financial compensation.

Windward Bio's Vision and Financing

Windward Bio, focused on advancing treatments for patients with advanced immunological conditions, is spearheaded by a team of seasoned drug development experts. Their current endeavor involves bringing this TSLP monoclonal antibody into phase 2 clinical trials. Recently, they completed a $200 million Series A financing round backed by high-profile investors, which will bolster their development initiatives.

Importance of SKB378/HBM9378

SKB378/HBM9378 is designed to offer potent inhibition of the TSLP signaling pathway, which is known to play a vital role in immunological disorders. This antibody is expected to be administered subcutaneously and boasts an engineered extended half-life, aimed at maximizing therapeutic efficacy while minimizing side effects.

In November 2024, a key step was taken when an investigational new drug (IND) application was submitted to China’s National Medical Products Administration (NMPA) for treating COPD. Phase 1 clinical trials have also been successfully conducted on healthy participants, laying the groundwork for future studies on moderate-to-severe asthma.

Kelun-Biotech's Commitment to Innovation

Kelun-Biotech's strategic direction emphasizes research and development in innovative biological drugs and small molecules, addressing significant health challenges across multiple disease areas, such as cancer, autoimmune, inflammatory, and metabolic diseases.

As a subsidiary of Kelun Pharmaceutical, the company maintains a robust commitment to establishing a global platform for drug development and commercialization, with over 30 ongoing projects.

Dr. Micheal Ge, CEO of Kelun-Biotech, expressed enthusiasm regarding this collaboration, highlighting its importance in validating the global market potential of SKB378/HBM9378 and marking a significant milestone in Kelun-Biotech’s journey in the immunology sector. With aspirations for further global expansion, Kelun-Biotech intends to leverage partnerships like this to bring impactful therapies to market and meet unmet medical needs effectively.

As the landscape of biopharmaceuticals continually evolves, collaborations such as the one between Kelun-Biotech and Windward Bio signify the growing determination to drive innovation in treating multifaceted diseases. Radically improving patient care, these efforts will hopefully yield significant advancements in delivering therapeutics that cater to the nuances of complex immunological conditions.