EASTONBIOPHARMACEUTICALS(SH:688513) Shang Hai Zheng Quan Bao·2025-09-17 20:57Core Viewpoint - Chengdu Yuandong Pharmaceutical Co., Ltd. has received the drug registration certificate for Arolol hydrochloride tablets, indicating compliance with drug registration requirements and marking a significant milestone for the company [1][5]. Drug Basic Information - Drug Name: Arolol hydrochloride tablets - Dosage Form: Tablets - Specification: 10mg - Registration Category: Class 4 chemical drug - 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: Guoyao Zhunzi H20255424 - Approval Conclusion: The drug meets the registration requirements as per the Drug Administration Law of the People's Republic of China [1]. Drug Indications and Market Context - Arolol hydrochloride tablets are primarily indicated for primary hypertension (mild to moderate), angina pectoris, tachyarrhythmia, and essential tremor. - The drug was developed by Sumitomo Company in Japan and was first approved for sale in Japan in November 1985, with importation 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 of Arolol hydrochloride tablets are already available from four companies: Shijiazhuang Grey Pharmaceutical, Beijing Xinnuo Kangqiao, Shandong Zhongjiankangqiao, and Beijing Fuyuan Pharmaceutical [2]. Sales Performance - According to data from key public hospitals in major provinces and cities, the sales amount of Arolol hydrochloride tablets in 2024 is approximately 144.55 million yuan, representing a year-on-year growth of 17.95% [3]. Impact on the Company - The approval of Arolol hydrochloride tablets, classified as a Class 4 chemical drug, signifies that the product has passed the consistency evaluation. However, the approval is not expected to have a significant impact on the company's short-term performance. The period from approval to production and sales may face uncertainties, and the company will fulfill its information disclosure obligations as required by law [5].