Core Viewpoint - Beihai Kangcheng Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for its innovative drug, Geronine, which is the first domestically developed long-term enzyme replacement therapy for treating type I and III Gaucher disease in adolescents and adults aged 12 and above [1][2] Group 1: Product Overview - Geronine is the first long-term enzyme replacement therapy for type I and III Gaucher disease patients aged 12 and above in China [1][2] - The drug is expected to significantly reduce the treatment costs for patients, with the average annual treatment cost for adult patients exceeding one million yuan [3] - The company aims to make the drug accessible to a larger patient population, targeting 80% of the approximately 3,000 Gaucher disease patients in China [3] Group 2: Market Strategy - Beihai Kangcheng plans to not only focus on the domestic market but also to develop international markets, holding global proprietary rights for Geronine [3] - The company is currently in discussions with government departments to ensure the drug's pricing aligns with patient needs and the healthcare payment system [3] Group 3: Production and Cost Efficiency - Geronine is the first innovative biological drug to pass the segmented production inspection, which is expected to lower production costs and accelerate the product's market entry [4] - The segmented production model allows different production stages to be outsourced, enhancing production efficiency and reducing costs [4] - The collaboration with WuXi Biologics for the production of Geronine is anticipated to save at least one to one and a half years in the product's time to market [4] Group 4: Company Background - Beihai Kangcheng, known as the "first stock of rare diseases in Hong Kong," focuses on the research, development, and commercialization of innovative therapies for rare diseases [5] - The company has been operating at a loss, reporting a revenue of 85.1 million yuan and a loss of 443 million yuan in 2024 [5] - The success of Geronine is seen as a potential turning point for the company's financial performance [5]