Core Viewpoint - The announcement highlights that Beihai Kangcheng-B has received approval from the National Medical Products Administration of China for the marketing of Velaglucerase beta (Goreining, CAN103) on May 15, 2025, for the treatment of Type I and Type III Gaucher disease [1] Group 1: Product Development - The company holds global exclusive rights for the development and commercialization of the product [1] - Goreining is the first domestically developed long-term enzyme replacement therapy for adolescents aged 12 and older and adults with Type I and Type III Gaucher disease [1] Group 2: Disease Overview - Gaucher disease is one of the most common lysosomal storage disorders caused by mutations in the glucocerebrosidase gene located on the long arm of chromosome 1q22 [1] - The disease affects both males and females equally, with clinical forms including Type 0 (perinatal lethal), Type I (chronic non-neuropathic), Type II (acute neuropathic), and Type III (chronic neuropathic), where patients with Type I and III can often live into adulthood [1] Group 3: Market Impact - The introduction of Goreining is expected to completely replace similar imported products, significantly enhancing the accessibility of medication for domestic patients [1]
北海康成-B：注射用维拉苷酶β获中国上市批准