人福医药: 人福医药关于多巴丝肼片获得药品注册证书的公告

Core Viewpoint - The announcement highlights that Renfu Pharmaceutical has received the drug registration certificate for its product, Dopamine Hydrazine Tablets, which allows the company to produce and sell the drug in the domestic market, thereby enriching its product line and potentially generating positive impacts on its business [1][3]. Group 1: Drug Registration Details - The drug name is Dopamine Hydrazine Tablets, which is indicated for the treatment of Parkinson's disease and symptomatic Parkinson's syndrome, excluding drug-induced Parkinson's syndrome [2]. - The registration approval was granted by the National Medical Products Administration, confirming that the product meets the necessary requirements for drug registration [2]. - The cumulative R&D investment for this project is approximately RMB 15 million [2]. Group 2: Market and Sales Potential - The estimated national sales for Dopamine Hydrazine Tablets in 2023 is around RMB 890 million, with the main competitor being Roche Pharmaceuticals [2]. - The company plans to arrange for the production and market launch of the drug based on market demand [3]. - The product's future sales may be influenced by industry policies and market conditions, indicating some level of uncertainty [3]. Group 3: Regulatory and Production Information - The drug is classified as a Class 4 chemical drug, with a shelf life of 24 months [3]. - The drug registration number is H20253650, and the approval is valid until March 17, 2030 [3]. - The production will be handled by Yichang Renfu Pharmaceutical Co., Ltd., a subsidiary of the company [3].