格隆汇11月11日丨方盛制药(603998.SH)公布，公司收到国家药监局核准签发的《药品注册证书》，公 司研发的吲哚布芬片已获得药品批准文号。药品名称：吲哚布芬片，药品批准文号：国药准字 H20255829。 吲哚布芬是一种异吲哚啉基丁酸衍生物，为一种血小板聚集的抑制剂。主要是通过以下机制发挥抗血小 板聚集作用：（1）可逆性抑制血小板环氧化酶，使血栓素B2（血小板聚集的强效激活剂）生成减少； （2）抑制二磷酸腺苷（ADP）、肾上腺素和血小板活化因子（PAF）、胶原和花生四烯酸诱导的血小 板聚集；（3）降低血小板三磷酸腺苷、血清素、血小板因子3、血小板因子4和β-凝血球蛋白的水平， 降低血小板粘附性。吲哚布芬片主要用于动脉硬化引起的缺血性心血管病变、缺血性脑血管病变、静脉 血栓形成。也可用于血液透析时预防血栓形成。 心脑血管用药市场需求催生了庞大用药市场，经过多年的技术研发与市场开拓，公司治疗心脑血管的药 物已占据一定的市场份额。公司已获批生产并在销的心脑血管疾病用药主要有：依折麦布片、厄贝沙坦 氢氯噻嗪片、血塞通片/分散片、杜仲平压分散片、银杏叶分散片、益心酮分散片等产品。吲哚布芬片 《药品注册证书》的取得 ...

吲哚布芬是一种异吲哚啉基丁酸衍生物，为一种血小板聚集的抑制剂。主要是通过以下机制发挥抗血小 板聚集作用：（1）可逆性抑制血小板环氧化酶，使血栓素B2（血小板聚集的强效激活剂）生成减少； （2）抑制二磷酸腺苷（ADP）、肾上腺素和血小板活化因子（PAF）、胶原和花生四烯酸诱导的血小 板聚集；（3）降低血小板三磷酸腺苷、血清素、血小板因子3、血小板因子4和β-凝血球蛋白的水平， 降低血小板粘附性。吲哚布芬片主要用于动脉硬化引起的缺血性心血管病变、缺血性脑血管病变、静脉 血栓形成。也可用于血液透析时预防血栓形成。 心脑血管用药市场需求催生了庞大用药市场，经过多年的技术研发与市场开拓，公司治疗心脑血管的药 物已占据一定的市场份额。公司已获批生产并在销的心脑血管疾病用药主要有：依折麦布片、厄贝沙坦 氢氯噻嗪片、血塞通片/分散片、杜仲平压分散片、银杏叶分散片、益心酮分散片等产品。吲哚布芬片 《药品注册证书》的取得一方面进一步丰富了公司心脑血管用药系列产品线，另一方面有利于提升公司 在心脑血管用药市场的竞争力，从而提高公司整体盈利水平。此外，根据《关于开展仿制药质量和疗效 一致性评价的意见》（国办发〔2016〕8 号）的相 ...

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].

Core Viewpoint - Meinuo Pharma has received approval from the National Medical Products Administration for the production and sale of Irbesartan Hydrochlorothiazide tablets, enhancing its market competitiveness and expanding its cardiovascular product pipeline [1] Group 1 - Meinuo Pharma's wholly-owned subsidiary, Ningbo Meinuo TianKang Pharmaceutical Co., Ltd., has obtained the drug registration certificate for Irbesartan Hydrochlorothiazide tablets [1] - The drug is indicated for the treatment of primary hypertension, which addresses a significant health issue [1] - The approval marks a significant milestone for the company, allowing it to produce and sell the drug in the domestic market [1] Group 2 - The introduction of this product is expected to positively impact the company's operational development [1] - The approval enhances the company's product offerings in the cardiovascular segment, which is crucial for growth in this therapeutic area [1]

Core Insights - Meinuo Pharma (603538) announced that its wholly-owned subsidiary, Ningbo Meinuo TianKang Pharmaceutical Co., Ltd., has received the drug registration certificate for Irbesartan Hydrochlorothiazide Tablets from the National Medical Products Administration [1] Group 1 - The approved drug is indicated for the treatment of primary hypertension [1]

Core Viewpoint - Meinuo Pharma (603538.SH) has received approval from the National Medical Products Administration for its product, Irbesartan Hydrochlorothiazide Tablets, which is indicated for the treatment of primary hypertension [1] Group 1: Product Approval - Meinuo Pharma's wholly-owned subsidiary, Ningbo Meinuo TianKang Pharmaceutical Co., Ltd., has obtained the drug registration certificate for Irbesartan Hydrochlorothiazide Tablets from the National Medical Products Administration [1] - The combination of Irbesartan, an angiotensin II receptor antagonist, and Hydrochlorothiazide, a thiazide diuretic, is designed to provide a synergistic effect in lowering blood pressure within the recommended therapeutic dosage range [1]

Core Viewpoint - Meinuo Pharma (603538.SH) has received approval from the National Medical Products Administration for its product, Irbesartan Hydrochlorothiazide Tablets, which is indicated for the treatment of primary hypertension [1] Company Summary - Meinuo Pharma's wholly-owned subsidiary, Ningbo Meinuo TianKang Pharmaceutical Co., Ltd., has been granted a drug registration certificate for Irbesartan Hydrochlorothiazide Tablets [1] - The drug is a combination of the angiotensin II receptor antagonist Irbesartan and the thiazide diuretic Hydrochlorothiazide, which work synergistically to lower blood pressure within the recommended therapeutic dosage range [1]

Core Viewpoint - Meheco's subsidiary, Meheco Tiankang, has received approval from the National Medical Products Administration for the registration of Eprosartan Hydrochlorothiazide Tablets, which are used to treat primary hypertension [1] Company Summary - The approved drug is a combination of angiotensin II receptor antagonist Eprosartan and thiazide diuretic Hydrochlorothiazide [1] - Meheco Tiankang has invested 5.8747 million yuan in the research and development of this drug [1] Market Summary - The global sales forecast for Eprosartan Hydrochlorothiazide Tablets in 2024 is projected to be 817 million USD, with sales in China expected to reach 184 million USD [1]

Core Viewpoint - Meinuo Pharma has received approval from the National Medical Products Administration for the registration of Irbesartan Hydrochlorothiazide tablets, enhancing its market competitiveness and expanding its cardiovascular product pipeline [1] Group 1 - Meinuo Pharma's wholly-owned subsidiary, Ningbo Meinuo TianKang Pharmaceutical Co., Ltd., has obtained the drug registration certificate for Irbesartan Hydrochlorothiazide tablets [1] - The drug is indicated for the treatment of primary hypertension, which addresses a significant health issue [1] - The approval allows the company to produce and sell the drug in the domestic market, positively impacting its operational development [1]