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 - Fuyuan Pharmaceutical's subsidiary, Zhejiang Aisheng Pharmaceutical Co., Ltd., has received a drug registration certificate for Dydrogesterone tablets (10mg) from the National Medical Products Administration of China [1] Company Summary - The drug Dydrogesterone is an orally absorbable synthetic progestogen, originally developed by Solvay Pharmaceuticals, which has since been acquired by Abbott [1] - Dydrogesterone was first approved for sale in Portugal in July 1961 and was subsequently approved for the Chinese market in December 2002 [1] - The medication is used to treat conditions caused by endogenous progesterone deficiency and for luteal support in assisted reproductive technology [1]

Core Viewpoint - The company received approval from the National Medical Products Administration for its product, Crizotinib capsules, which has been in the Chinese market since 2013 and included in medical insurance since 2018, demonstrating over ten years of clinical application experience [1] Company Summary - Crizotinib capsules are primarily used for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients who are positive for anaplastic lymphoma kinase (ALK) and for patients with advanced NSCLC who are positive for ROS1 [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for its product, Crizotinib capsules, which has been in the Chinese market since 2013 and included in medical insurance since 2018, demonstrating over ten years of clinical application experience [1] Group 1 - Crizotinib capsules are primarily used for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) patients who are positive for anaplastic lymphoma kinase (ALK) and for those with advanced NSCLC who are positive for ROS1 [1]

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 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]

Core Viewpoint - Zhejiang Anglikang Pharmaceutical Co., Ltd. has received the drug registration certificate for Levofloxacin Tablets from the National Medical Products Administration, which is expected to enhance the company's product pipeline and market presence [1][2]. Group 1: Drug Information - Levofloxacin Tablets are the left-handed optical isomer of Ofloxacin, classified as a third-generation fluoroquinolone antibiotic, known for its broad antibacterial spectrum and strong antibacterial action [1]. - The drug is indicated for the treatment of moderate to severe infections in adults (≥18 years) caused by specified sensitive strains, including hospital-acquired pneumonia, community-acquired pneumonia, acute bacterial sinusitis, acute exacerbations of chronic bronchitis, complex skin and skin structure infections, uncomplicated skin and soft tissue infections, and chronic bacterial prostatitis [1]. Group 2: Impact on the Company - The approval of Levofloxacin Tablets will further enrich the company's product pipeline, potentially leading to increased market opportunities [2]. - However, the sales of pharmaceuticals are subject to uncertainties due to the unique nature of the industry, influenced by national policies and market environment changes [2].

Group 1 - Warner Pharmaceuticals received the drug registration certificate for polyethylene glycol sodium potassium powder, which is indicated for the treatment of chronic constipation and fecal impaction [1] - The approval of the drug registration certificate enriches the company's formulation product variety and positively impacts the optimization of the product structure [1] - Warner Pharmaceuticals reported a revenue of 714 million yuan for the first half of 2025, a year-on-year decrease of 3.37%, with a net profit attributable to shareholders of 71 million yuan, down 36.95% [1] Group 2 - Renfu Pharmaceutical announced that its subsidiary, Wuhan Jiulong Renfu Pharmaceutical Co., received the drug registration certificate for dapoxetine hydrochloride tablets, which are used to treat premature ejaculation [2] - The total sales of dapoxetine hydrochloride tablets in 2024 are estimated to be around 1.1 billion yuan, with major manufacturers including Shandong Huabo Kaisheng Biotechnology Co. and Sichuan Kelun Pharmaceutical Co. [2] - Anglikon received the drug registration certificate for azilsartan potassium tablets, which are indicated for the treatment of primary hypertension in adults [3] - Xinhua Pharmaceutical announced the approval of fumarate bisoprolol tablets, indicated for hypertension and chronic stable heart failure with reduced left ventricular function [3]

Core Viewpoint - The company announced that its wholly-owned subsidiary, Huaren Shuanghe Limin Pharmaceutical (Jinan) Co., Ltd., has received a drug registration certificate for Bosentan dispersible tablets from the National Medical Products Administration (NMPA) [1][2]. Group 1: Drug Registration and Development - The drug Bosentan dispersible tablets are indicated for pulmonary arterial hypertension (PAH) in pediatric patients aged 3 years and older, as well as for adult patients classified as WHO functional class II to IV [1][2]. - The development of this generic drug began in 2022, with the application for marketing authorization submitted on June 14, 2024, and approval granted on September 23, 2025 [2]. Group 2: Market Situation - Bosentan dispersible tablets were developed by Actelion Pharmaceuticals Ltd and were approved for sale in the EU in 2009 under the brand name "Tracleer." The drug was imported into China in September 2019 under the brand name "Quankeli" [3]. - In 2024, the global sales of Bosentan dispersible tablets reached approximately $35.9 million, with "Tracleer" accounting for about $31.3 million of that total [3]. - In the Chinese market, the total sales of Bosentan dispersible tablets were approximately 2.126 million yuan in 2024, with Johnson & Johnson holding a 100% market share [3]. Group 3: Impact on the Company - The acquisition of the drug registration certificate is expected to enhance the company's product line and market competitiveness, while also providing valuable experience for future product development [4].

Core Viewpoint - Aimer (300896.SZ) announced that its wholly-owned subsidiary, Beijing Nobot Biotechnology Co., Ltd., has received approval from the National Medical Products Administration for the registration of Minoxidil topical solution in 2% and 5% concentrations, which are non-prescription dermatological medications [1] Group 1 - The 2% formulation is indicated for the treatment of androgenetic alopecia and alopecia areata [1] - The 5% formulation is restricted for use by males only, also for the treatment of androgenetic alopecia and alopecia areata [1] - Minoxidil is a peripheral vasodilator that, when used topically over a long period, can stimulate hair growth in male patients suffering from androgenetic alopecia and alopecia areata [1]