Harbour BioMed Receives China NMPA Approval of Batoclimab Injection (Subcutaneous Injection) for the Treatment of Generalized Myasthenia Gravis
Source: The Manila times
Published on: 2026-10-23 02:22
The first NMPA-approved anti-FcRn therapy to complete its full clinical development for gMG patients in China CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, Oct. 23, 2026 /PRNewswire/ -- Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other areas, today announced that the National Medical Products Administration (NMPA) of China has approved the Biologics License Application (BLA) for batoclimab injection (subcutaneous injection) (batoclimab SC), 170 mg (1 mL)/vial, for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. The approval is supported by positive results from a pivotal Phase 3 clinical study conducted at 27 centers in China. The main study population was p...
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