上海现代制药股份有限公司关于全资子公司获得药品注册证书的公告

Core Viewpoint - Shanghai Modern Pharmaceutical Co., Ltd.'s wholly-owned subsidiary, China National Pharmaceutical Group Industrial Co., Ltd., has received a drug registration certificate for Hydromorphone Hydrochloride Injection, marking a significant step in expanding its product line in the analgesic sector [1][3]. Group 1: Drug Information - The drug is named Hydromorphone Hydrochloride Injection, with a specification of 1ml:2mg and classified as a Class 3 chemical drug [1]. - The drug registration certificate number is 2025S03532, and the approval number is 国药准字H20256055, with a validity period of 18 months [1]. - The production facility is located in Langfang Economic and Technological Development Zone, and the drug is intended for patients requiring opioid analgesia [2]. Group 2: Market and R&D Situation - Sales figures for Hydromorphone Hydrochloride Injection in public medical institutions over the past three years were RMB 41.34 million in 2022, RMB 74.84 million in 2023, and RMB 71.68 million in 2024 [2]. - The cumulative R&D investment for the Hydromorphone Hydrochloride Injection project is approximately RMB 4.728 million [2]. - Other companies, such as Yichang Renfu Pharmaceutical Co., Ltd., have also obtained registration certificates for the same drug [2]. Group 3: Impact on the Company - The approval of the drug registration certificate allows the company to produce and sell the product in the domestic market, enhancing its competitive position in the analgesic market [3][4]. - This development is expected to positively influence the company's future growth, although it will not have a significant immediate impact on current operating performance [4].