Harbour BioMed Resubmits BLA for Batoclimab to NMPA for Treatment of Generalized Myasthenia Gravis

27 June 2024 | Thursday | News

Innovative Antibody Therapy Demonstrates Positive Phase III Results and Long-Term Safety Data, Aiming to Enhance Treatment for gMG Patients in China.
Image Source : Public Domain

Image Source : Public Domain

Harbour BioMed , a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on oncology and immunology, announces that it has resubmitted the Biologics License Application (BLA) of batoclimab (HBM9161) to the National Medical Products Administration (NMPA) of China for the treatment of generalized myasthenia gravis (gMG).


Following the clinical trial protocol, the Company completed the extension period for the Phase III clinical trial to collect additional long-term safety data without enrolling new patients. As a result, the Company voluntarily included this additional safety data and resubmitted the BLA for batoclimab (HBM9161) as planned.

"We are delighted to resubmit the BLA to the NMPA as scheduled and will continuously communicate closely with the NMPA to advance the review process of this innovative therapy. Based on the results of the Phase III clinical trial, which demonstrated the efficacy of batoclimab in both primary and secondary endpoints, we believe this innovative therapy will further enhance the treatment of generalized myasthenia gravis and benefit more patients," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed.

Batoclimab received the "Breakthrough Therapy Certificate" from the NMPA in 2021 and achieved a positive outcome in the proof-of-concept study for treating Chinese gMG patients in July 2021. The positive topline 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 Greater China. Under this agreement, the Company is responsible for developing and conducting 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.


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