一品红(300723.SZ)全资子公司获得磷酸奥司他韦胶囊药品补充申请批准通知书

Core Viewpoint - The company has received approval from the National Medical Products Administration for the addition of a 45mg specification of Oseltamivir Phosphate capsules, expanding its product offerings in the antiviral market [1][2] Group 1: Product Approval - The company’s subsidiary, Guangzhou Yipinhong Pharmaceutical Co., Ltd., has been granted a drug supplement application approval notice for Oseltamivir Phosphate capsules, allowing the addition of a 45mg specification [1] - The approval includes changes to the excipient quantities in the formulation, packaging materials, and registration standards, with a validity period of 12 months [1] Group 2: Indications and Usage - The approved indications for Oseltamivir Phosphate capsules include treatment for adults and children aged 1 year and older for both type A and type B influenza, with a recommendation for use within 48 hours of symptom onset [1] - The capsules are also indicated for the prevention of type A and type B influenza in adults and adolescents aged 13 years and older [1] Group 3: Market Position and Sales - Oseltamivir Phosphate is a neuraminidase inhibitor recommended by the World Health Organization and is a first-line antiviral drug for influenza as per the 2025 Influenza Diagnosis and Treatment Plan [2] - The product is classified as a Category B drug under the national medical insurance and is included in the 2018 essential drug list in China [2] - Sales of Oseltamivir in Chinese urban public hospitals and county-level public hospitals are projected to be approximately 322.571 million RMB in 2024 [2]