Harbour BioMed's Batoclimab Receives NMPA Acceptance for Generalized Myasthenia Gravis Treatment

30 June 2023 | Friday | News

Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on oncology and immunology, announces that the National Medical Products Administration (NMPA) of China has accepted the Biologics License Application (BLA) of batoclimab (HBM9161) for the treatment of generalized myasthenia gravis (gMG). This is the first BLA accepted by NMPA since Harbour BioMed's establishment.
Image Source : Public Domain

Image Source : Public Domain

"Anti-FcRn treatment is at the center of focus igMG disease area. Batoclimab is the first anti-FcRn treatment completed clinical development with positive results and confirmed efficacious and safe in Chinese gMG population. We believe that this innovative therapy  will set a new benchmark  for  the treatment of gMG, significantly improve drug availability and benefit more patients," said the principal investigator Chongbo Zhao, MD, Professor of Neurology at Huashan Hospital of Fudan University in Shanghai.

"We are delighted that batoclimab has become our first BLA successfully accepted by the NMPA demonstrating our strong R&D capability. The clinical studies of batoclimab, spanning the pandemic, are the result of joint efforts of investigators and patients with Harbour BioMed, and its success sets a monumental milestone for the development of  innovative therapeutics in the treatment of gMG. We are excited  to bring this much-needed drug to patients, and will continue to advance our innovative pipeline of next-generation therapeutics to fulfill the unmet medical needs." said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed.

Batoclimab received the "Breakthrough Therapy Certificate" from NMPA in 2021, and subsequently achieved the positive outcome of the proof-of-concept study for the treatment of Chinese gMG patients completed in July 2021. The positive results of its phase III clinical trial were announced in March 2023.

In October 2022, the Company entered into an agreement with NBP Pharma, a wholly owned subsidiary of the CSPC Group, to co-develop batoclimab in Great China. The Company was responsible for developing and operating the full clinical trial of batoclimab for gMG in China, and will receive tiered royalties based on annual net sales of batoclimab in Greater China according to the agreement.

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