Chinese biopharmaceutical company Harbour BioMed (HKEX:02142) announced on Thursday that China's National Medical Products Administration (NMPA) has approved the Biologics License Application (BLA) for batoclimab injection (subcutaneous injection) (batoclimab SC), 170 mg (1 mL)/vial, for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

This approval is supported by positive results from a pivotal Phase 3 clinical study conducted at 27 centres in China. In the study, 58.2% of patients treated with batoclimab SC achieved the primary endpoint of sustained improvement in the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) score during the first cycle of treatment. This was significantly higher than 31.3% in the placebo group, and treatment effect was observed as early as the second week of therapy.

The batoclimab SC group also demonstrated significant improvements in secondary endpoints compared with placebo group, and the treatment was generally well tolerated.

"Batoclimab SC is the first FcRn-targeted therapy to complete its entire clinical development in China," said Professor Chongbo Zhao, MD, principal investigator of the pivotal Phase 3 study and Professor of Neurology at Huashan Hospital of Fudan University. "The trial results showed rapid onset of action, deep symptom improvement, and a favourable safety profile. This high-level evidence, based on data from Chinese patients, indicates that batoclimab SC provides a new treatment option for myasthenia gravis."

Under the licence agreement between Harbour BioMed and NBP Pharma, commercialisation of batoclimab in the Greater China region (Mainland China, Hong Kong, Macau, and Taiwan) will be conducted by NBP Pharma, a subsidiary of CSPC Pharmaceutical Group. Harbour BioMed will receive tiered royalties based on annual net sales of batoclimab in Greater China.