HBM HOLDINGS-B(02142): Batoclimab Injection (Subcutaneous Injection) Receives NMPA Approval for Marketing for the Treatment of Generalized Myasthenia Gravis
HBM Holdings-B (02142) announces 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) for use 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 the Company's core product 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.
HBM HOLDINGS-B(02142) announced 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) for use 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 the Company's core product 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.
Pursuant to the license agreement entered into between the Group and NBP Pharmaceutical, a subsidiary of CSPC PHARMA, in October 2022, the commercialization of Batoclimab in Greater China (including Mainland China, Hong Kong, Macau and Taiwan) is undertaken by a subsidiary of CSPC PHARMA. The Group is entitled to receive tiered royalties based on the annual net sales of Batoclimab in Greater China.
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