Core Viewpoint - Chengdu Yuandong Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of its drug, Ethyl Pheylbutazone Tablets, marking a significant milestone for the company in the pharmaceutical market [1][2]. Drug Basic Information - Drug Name: Ethyl Pheylbutazone Tablets - Dosage Form: Tablets - Specification: 50mg - Registration Category: Chemical Drug Class 4 - Validity Period: 18 months - Holder of Marketing Authorization: Chengdu Shode Pharmaceutical Co., Ltd. - Production Company: Chengdu Shode Pharmaceutical Co., Ltd. - Registration Standard Number: YBH23792025 - Acceptance Number: CYHS2402415 - Certificate Number: 2025S02973 - Approval Document Number: Guoyao Zhunzi H20255554 - Approval Conclusion: The drug meets the registration requirements as per the relevant laws and regulations [1]. Drug Indications and Market Context - The primary active ingredient is Ethyl Pheylbutazone, indicated for conditions such as cervical, shoulder, and lumbar pain, as well as various spastic paralysis conditions [2]. - The drug was originally developed by Eisai Co., Ltd. in Japan and was first approved for sale in Japan in February 1983, later imported to China in July 2004 [2]. - It is classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Directory (2024) [2]. - The drug is the first generic drug approved under the new registration classification, equivalent to passing the consistency evaluation [2]. - Sales data from major public hospitals indicate that the expected sales for Ethyl Pheylbutazone Tablets in 2024 are approximately 102.61 million yuan, reflecting a year-on-year growth of 14.01% [2]. Impact on the Company - The approval of Ethyl Pheylbutazone Tablets signifies that the product meets the necessary registration requirements, although it is not expected to have a significant impact on the company's short-term performance [3]. - The period from approval to market production may face uncertainties, and the company will fulfill its information disclosure obligations as required by law [3].
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