#China #Chengdu #Kelun-Biotech #Harbour BioMed #Asthma Treatment

Kelun-Biotech and Harbour BioMed Gain NMPA Approval for SKB575/HBM7575

In a significant advancement in the treatment of asthma, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. and Harbour BioMed have announced that the National Medical Products Administration (NMPA) in China has approved their Investigational New Drug (IND) application for SKB575/HBM7575. This innovative long-acting bispecific antibody targets thymic stromal lymphopoietin (TSLP) as well as an undisclosed target. The announcement signals a crucial step forward in addressing the needs of approximately 300 million asthma patients worldwide.

Asthma, a chronic respiratory condition, continues to impact lives globally, with many patients experiencing persistent symptoms and frequent exacerbations. Current treatment options, like inhaled corticosteroids (ICS) and bronchodilators, are often insufficient for a significant number of patients. The need for more effective, long-term therapeutic options that tackle asthma's underlying mechanisms has become increasingly urgent.

Dr. Michael Ge, CEO of Kelun-Biotech, expressed his enthusiasm regarding the approval, highlighting the company's dedication to advancing SKB575/HBM7575 through clinical trials for both asthma and atopic dermatitis. Dr. Ge stated, "As a differentially designed and engineered bispecific antibody, SKB575/HBM7575 is expected to provide substantial control of inflammation while accommodating a wide array of patients through its dual-target mechanism and convenient administration routes. We are fully committed to developing this drug to unlock its clinical potential."

A Deep Dive into SKB575/HBM7575

Understanding the Mechanism: SKB575/HBM7575 operates through a dual mechanism of action. It inhibits TSLP-mediated signaling pathways that activate Th2 immune cells while additionally blocking an undisclosed target to amplify the control of inflammation. This dual-action approach is anticipated to provide broader and more effective responses compared to conventional single-target therapies. Moreover, the engineering behind this therapeutic antibody allows for longer dosing intervals and a simple subcutaneous route of administration. Based on preclinical studies, it is expected to support dosing intervals exceeding three months, optimizing patient compliance.

Collaboration Insights

The collaboration between Kelun-Biotech and Harbour BioMed plays a pivotal role in the development and commercialization of SKB575/HBM7575. Under this agreement, Kelun-Biotech leads the innovation, global development, and marketing initiatives, while Harbour BioMed contributes towards investment and developmental efforts alongside sharing the benefits derived from this project. This synergy is vital in expediting the drug's journey toward market availability.

Corporate Background

Kelun-Biotech, listed as 6990.HK, operates as a subsidiary of Kelun Pharmaceutical. The company emphasizes research and development, manufacturing, and the commercialization of innovative biological and small molecule drugs. It focuses on addressing significant disease areas such as oncology, autoimmune disorders, inflammatory conditions, and metabolic diseases. With over 30 ongoing prominent innovative drug projects, Kelun-Biotech is on a mission to become a foremost global entity in the field of innovative drug development.

In parallel, Harbour BioMed, trading under HKEX 02142, is dedicated to discovering and developing groundbreaking antibody therapeutics, particularly in immunology and oncology. Its proprietary technologies, including Harbour Mice®, enable the generation of fully human monoclonal antibodies, paving the way for advanced treatment options for a diverse range of diseases.

Conclusion

The NMPA's approval of SKB575/HBM7575 marks a promising milestone in asthma treatment. With its potential as a best-in-class therapy, this bispecific antibody could not only enhance patient outcomes but also substantially influence the future landscape of asthma management. As both companies continue to advance their collaborative efforts, the development of innovative therapeutic solutions remains a shared commitment in the fight against chronic diseases such as asthma.