宁波美诺华药业股份有限公司 关于全资子公司获得厄贝沙坦 氢氯噻嗪片药品注册证书的公告

Core Viewpoint - Ningbo Meinuo Pharmaceutical Co., Ltd. has received the drug registration certificate for Irbesartan and Hydrochlorothiazide tablets from the National Medical Products Administration, enhancing its market competitiveness and expanding its cardiovascular product pipeline [1][5]. Drug Information - Drug Name: Irbesartan and Hydrochlorothiazide Tablets - Dosage Form: Tablets - Specification: Each tablet contains 150mg of Irbesartan and 12.5mg of Hydrochlorothiazide [1][2]. - Application: Drug registration for domestic production [2]. - Approval Validity: Until October 13, 2030 [2]. - Holder of Marketing Authorization: Ningbo Meinuo Tiankang Pharmaceutical Co., Ltd. [2]. - Manufacturing Company: Ningbo Meinuo Tiankang Pharmaceutical Co., Ltd. [2]. - Approval Conclusion: The drug meets the registration requirements as per the Drug Administration Law of the People's Republic of China [2]. Drug Indications and Market Context - Indication: Used for the treatment of primary hypertension [3]. - Composition: A combination of the angiotensin II receptor antagonist Irbesartan and the thiazide diuretic Hydrochlorothiazide, which can produce a synergistic effect in lowering blood pressure [3]. - R&D Investment: As of the announcement date, the company has invested approximately RMB 5.8747 million in research and development [3]. - Market Competition: Major approved companies for this drug in China include China National Pharmaceutical Group Corporation, Beijing Four Rings Keba Pharmaceutical Co., Ltd., and Jiangsu Zhengda Tianqing Pharmaceutical Co., Ltd. [3]. - Global Sales: The global sales of Irbesartan and Hydrochlorothiazide tablets reached USD 817 million in 2024, with sales in China amounting to USD 184 million [3]. Impact on Company - The approval of Irbesartan and Hydrochlorothiazide tablets signifies the company's qualification for production and sales in the domestic market, positively impacting its operational development and enhancing product competitiveness [5].