Core Viewpoint - Jinling Pharmaceutical Co., Ltd. has received a drug re-registration approval notice for its Hydrolyzed Protein Injection, which will facilitate the resumption of production and sales of this product [1][3]. Group 1: Drug Registration Details - The drug in question is Hydrolyzed Protein Injection, which is a sterilized solution of hydrolyzed casein and whey protein with sorbitol, primarily used for severe amino acid deficiency due to major surgical trauma, extensive burns, and various diseases causing hypoproteinemia [2]. - The application for re-registration was accepted under the number CYHZ2514512, and the approval was granted by the Fujian Provincial Drug Administration [1]. Group 2: Impact on the Company - The approval for the re-registration of the drug will benefit the company by allowing the resumption of normal production and sales; however, it is not expected to have a significant impact on the company's recent operating performance [3]. - The company is required to conduct subsequent work in strict accordance with regulatory requirements to achieve market sales of the product [3].
金陵药业股份有限公司关于分公司收到 药品再注册批准通知书的公告