Core Viewpoint - North China Pharmaceutical Co., Ltd. has received the Drug Registration Certificate for Adenosylcobalamin Capsules (0.5mg) from the National Medical Products Administration, indicating the product's compliance with quality and efficacy standards for generic drugs [1][2]. Group 1: Drug Registration Details - The Drug Registration Certificate for Adenosylcobalamin Capsules (0.5mg) was approved on July 29, 2025, after being submitted for review in April 2024 [2][4]. - Adenosylcobalamin is primarily used for the prevention and treatment of Vitamin B12 deficiency and related conditions, such as megaloblastic anemia [2][5]. Group 2: Research and Development - The company has invested a total of 10.9382 million yuan in research and development for this product [3]. - The product is expected to be produced and marketed following the receipt of the registration certificate [4]. Group 3: Market Situation - A total of 27 companies, including North China Pharmaceutical, hold the Drug Registration Certificate for Adenosylcobalamin Capsules (0.5mg) in China [5]. - The sales volume for the capsule form is projected to be approximately 29,000 units in 2024, with total sales across all forms expected to reach around 1.5 billion units, reflecting a 19% increase from 2023 [5]. Group 4: Impact on the Company - The approval of the Drug Registration Certificate enhances the company's product pipeline in hematology and hematopoietic system medications, meeting the basic requirements for centralized procurement bidding [6].
华北制药股份有限公司关于公司获得《药品注册证书》的公告