Harbour BioMed resubmits BLA for batoclimab to China’s NMPA for generalized myasthenia gravis

Harbour BioMed (HKEX: 02142), a prominent global biopharmaceutical company, has announced the resubmission of the Biologics License Application (BLA) for batoclimab (HBM9161) to the National Medical Products Administration (NMPA) of China. This resubmission is a significant step toward the potential approval and commercialization of batoclimab for the treatment of generalized myasthenia gravis (gMG), a debilitating autoimmune disorder.

Following the successful completion of a Phase III clinical trial, including an extension period to gather additional long-term safety data, Harbour BioMed has reinforced the BLA with comprehensive safety profiles without enrolling new patients. This meticulous approach underscores the company’s commitment to ensuring the highest standards of patient safety and regulatory compliance.

Batoclimab, which received the “Breakthrough Therapy Certificate” from the NMPA in 2021, has shown promising results in both the primary and secondary endpoints of its Phase III clinical trial. Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, expressed optimism about batoclimab’s potential impact: “We believe this innovative therapy will further enhance the treatment of generalized myasthenia gravis and benefit more patients,” he stated.

In 2022, Harbour BioMed entered a strategic agreement with NBP Pharma, a subsidiary of the CSPC Group, to co-develop batoclimab in Greater China. This partnership allows Harbour BioMed to focus on clinical trials and development in China, while also setting the stage for significant economic returns through tiered royalties based on the annual net sales in the region.

Generalized myasthenia gravis is an advanced form of myasthenia gravis, characterized by muscle weakness that severely impacts daily activities and quality of life. Current treatments, including cholinesterase inhibitors and immunosuppressants, often fall short of addressing the clinical needs of patients, highlighting a significant unmet need for more effective and safer options.

Batoclimab, a fully human anti-FcRn monoclonal antibody, represents a new class of treatment by accelerating the degradation of pathogenic autoantibodies. The therapy has demonstrated the ability to significantly alleviate symptoms and improve the quality of life for patients with gMG, offering a potential breakthrough in autoimmune disease treatment.

The strategic resubmission of batoclimab’s BLA by Harbour BioMed not only highlights its potential as a transformative therapy for patients with generalized myasthenia gravis but also illustrates the company’s robust approach to innovation and compliance in the biopharmaceutical field. This could mark a significant advancement in autoimmune disease management, providing new hope for patients affected by this challenging condition.