HBM Holdings-B (02142): Batoclimab Subcutaneous Injection Approved by NMPA for Marketing to Treat Generalized Myasthenia Gravis

Stock News10-23

HBM Holdings-B (02142) has issued an announcement that the National Medical Products Administration (NMPA) of China has approved the marketing of batoclimab injection (subcutaneous injection) (batoclimab subcutaneous injection) (170 mg (1 mL)/vial), in combination with conventional therapeutic drugs, for the treatment of adult patients with anti-acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (gMG).

Batoclimab (HBM9161) is a core product of the company under Chapter 18A of the Listing Rules. Batoclimab subcutaneous injection is the group's first approved product and also the first anti-neonatal Fc receptor (FcRn) therapy to complete full clinical development for gMG patients in China.

Under the licensing agreement signed between the group and CSPC Pharmaceutical Group's subsidiary NBP Pharmaceutical in October 2022, the commercialization of batoclimab in Greater China (including Mainland China, Hong Kong, Macau, and Taiwan) is handled by CSPC Pharmaceutical Group's subsidiary. The group is entitled to receive tiered royalties based on annual net sales of batoclimab in Greater China.

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