成都苑东生物制药股份有限公司关于自愿披露盐酸乙哌立松片获得药品注册证书的公告

Core Viewpoint - Chengdu Yuandong Pharmaceutical Co., Ltd. has received the drug registration certificate for its product, Hydrochloride Ephedrine Tablets, marking a significant milestone in its product portfolio and compliance with regulatory standards [1][2]. Drug Basic Information - Drug Name: Hydrochloride Ephedrine Tablets - Dosage Form: Tablets - Specification: 50mg - Registration Category: Class 4 Chemical Drug - Validity Period: 18 months - Holder of Marketing Authorization: Chengdu Shuo De Pharmaceutical Co., Ltd. - Production Company: Chengdu Shuo De Pharmaceutical Co., Ltd. - Drug Registration Standard Number: YBH23792025 - Approval Conclusion: The product meets the requirements for drug registration and has been granted a registration certificate [1][2]. Drug Indications - Hydrochloride Ephedrine Tablets are indicated for: 1. Improving muscle tension in conditions such as cervical shoulder-arm syndrome, periarthritis of the shoulder, and low back pain 2. Spastic paralysis caused by cerebrovascular disorders, spastic myelopathy, cervical spondylosis, postoperative sequelae, traumatic sequelae, amyotrophic lateral sclerosis, infantile cerebral palsy, and other spinal cord diseases [2]. Market Performance - The sales amount for Hydrochloride Ephedrine Tablets in public hospitals in key provinces and cities is projected to be approximately 102.61 million yuan in 2024, reflecting a year-on-year growth of 14.01% [3]. Impact on the Company - The approval of Hydrochloride Ephedrine Tablets signifies that the product meets the necessary registration requirements and is considered to have passed the consistency evaluation. However, it is noted that the approval will not have a significant impact on the company's short-term performance [4].