Harbour BioMed (HKG: 2142), a biotech company with operations in the United States, the Netherlands, and Suzhou, China, has announced that the National Medical Products Administration (NMPA) has accepted a biological license application for its batoclimab (HBM9161) for the treatment of generalized myasthenia gravis (gMG). This development follows the positive topline results from a Phase III study in gMG conducted in China earlier this year.
Batoclimab’s Mechanism of Action and Phase II Study Outcomes
Batoclimab (HBM9161) is a human anti-FcRn monoclonal antibody that blocks FcRn-IgG interactions, thereby accelerating the degradation of autoantibodies and leading to the treatment of pathogenic IgG-mediated autoimmune diseases. A Phase II study in myasthenia gravis demonstrated that batoclimab can quickly and significantly alleviate symptoms and improve the quality of life for patients, positioning it as a promising therapy for gMG.
Landmark Licensing Deal with CSPC Pharmaceutical Group
In October 2022, CSPC Pharmaceutical Group Co., Ltd’s wholly-owned subsidiary, Shijiazhuang Pharma Group NBP Pharmaceutical (Shijiazhuang) Co. Ltd, entered into a significant licensing agreement with Harbour Bio, valued at RMB 1 billion (USD 144 million). This agreement grants the subsidiary exclusive development, manufacturing, and commercialization rights to batoclimab in Greater China, highlighting the drug’s potential impact on the regional market.-Fineline Info & Tech
