Core Viewpoint - Chengdu Yuandong Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of Arolol Hydrochloride Tablets, indicating compliance with drug registration requirements and marking a significant step for the company in the pharmaceutical market [1][4]. Drug Basic Information - Drug Name: Arolol Hydrochloride Tablets - Dosage Form: Tablets - Specification: 10mg - Registration Category: Chemical Drug Class 4 - Validity Period: 18 months - License Holder: Chengdu Yuandong Pharmaceutical Co., Ltd. - Production Company: Chengdu Yuandong Pharmaceutical Co., Ltd. - Registration Standard Number: YBH22152025 - Acceptance Number: CYHS2402067 - Certificate Number: 2025S02824 - Approval Document Number: National Drug Standard H20255424 [1]. Drug Related Information - The main active ingredient is Arolol Hydrochloride, primarily indicated for primary hypertension (mild to moderate), angina pectoris, tachyarrhythmia, and essential tremor. - Developed by Sumitomo in Japan, the drug was first approved for sale in Japan in November 1985 and imported to China in August 1995. - It is classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2024). - Domestic generic versions are already available from four companies: Shijiazhuang Grey Pharmaceutical, Beijing Xinnuo Kangqiao, Shandong Zhongjiankangqiao, and Beijing Fuyuan Pharmaceutical [2]. Market Impact - Sales of Arolol Hydrochloride Tablets in public hospitals in key provinces and cities are projected to reach approximately 144.55 million yuan in 2024, reflecting a year-on-year growth of 17.95% [3]. Company Impact - The approval of Arolol Hydrochloride Tablets, classified under Chemical Drug Class 4, signifies that the product has passed the consistency evaluation, although it is not expected to have a significant impact on the company's short-term performance [4].
成都苑东生物制药股份有限公司 关于自愿披露盐酸阿罗洛尔片获得药品注册证书的公告