Harbour BioMed (HKG: 2142), a biopharmaceutical company with operations in the United States, the Netherlands, and Suzhou, China, has announced the resubmission of a biological license application (BLA) to China’s National Medical Products Administration (NMPA) for its drug candidate batoclimab (HBM9161) for the treatment of generalized myasthenia gravis (gMG).
Batoclimab (HBM9161) is designed to block FcRn-IgG interactions, which accelerates the degradation of autoantibodies, and is used for the treatment of pathogenic IgG-mediated autoimmune diseases. A Phase II study in myasthenia gravis indicated that batoclimab can rapidly and significantly alleviate symptoms and enhance the quality of life for patients.
In October 2022, CSPC Pharmaceutical Group Co., Ltd’s (HKG: 1093) wholly-owned subsidiary, Shijiazhuang Pharma Group NBP Pharmaceutical (Shijiazhuang) Co. Ltd, entered into a licensing agreement worth RMB 1 billion (USD 144 million) with Harbour Bio, securing exclusive rights to develop, manufacture, and commercialize the product in Greater China.
Harbour Bio initially submitted a BLA in March 2023, which was withdrawn in December 2023 to incorporate additional long-term safety data from a Phase III study that confirmed the drug’s efficacy and safety profile. The company communicated with the NMPA to address the filing and delayed the Phase III clinical trials during this period, with no new patients recruited. Harbour Bio voluntarily planned to include the additional long-term safety data and resubmit the BLA, with active communication ongoing with the NMPA. The refiling was anticipated to take place in the first half of 2024.- Flcube.com
