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山东新华制药股份获得米诺地尔搽剂《药品注册证书》
Zhi Tong Cai Jing· 2025-08-26 09:41
Core Viewpoint - Shandong Xinhua Pharmaceutical has received approval from the National Medical Products Administration for the registration of Minoxidil lotion, which is expected to enhance the company's product portfolio and overall competitiveness [1] Company Summary - The Minoxidil lotion was approved for registration in August 2025, indicating a future expansion in the company's product offerings [1] - This approval is anticipated to strengthen the company's market position and competitive edge in the pharmaceutical industry [1]
人福医药:子公司注射用苯磺酸瑞马唑仑获得药品注册证书
Xin Lang Cai Jing· 2025-08-25 09:04
Group 1 - The core point of the article is that Yichang Renfu Pharmaceutical, a subsidiary of Renfu Pharmaceutical, has received approval from the National Medical Products Administration for the injection of remimazolam benzenesulfonate, expanding its usage in sedation during mechanical ventilation in intensive care [1] - The newly approved indication for remimazolam benzenesulfonate is as a sedative for patients undergoing mechanical ventilation in intensive care, which is expected to broaden the product's application [1] - The future sales performance of this product may be influenced by industry policies and market conditions, indicating a level of uncertainty [1]
珠海润都制药股份有限公司关于氢氯噻嗪获得 化学原料药上市申请批准通知书的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-08-20 19:53
Group 1 - The company, Zhuhai Runduo Pharmaceutical Co., Ltd., has received the approval notice for the listing application of hydrochlorothiazide as a chemical raw material drug from the National Medical Products Administration [1][2] - The drug hydrochlorothiazide is indicated for conditions such as edema, hypertension, central or renal diabetes insipidus, and nephrolithiasis [3] - The approval of this drug enhances the company's product portfolio and strengthens its full industry chain layout, positively impacting future operational performance [3] Group 2 - The application for the drug was submitted in April 2024, with the approval process involving additional research and documentation submitted in 2025 [2] - The approval is based on compliance with the relevant requirements of the Drug Administration Law of the People's Republic of China [1]
昂利康:获得西格列汀二甲双胍缓释片药品注册证书
Xin Lang Cai Jing· 2025-07-31 09:04
Core Viewpoint - The company has received the drug registration certificate for the combination drug Sitagliptin Metformin Extended-Release Tablets from the National Medical Products Administration, which is intended for adult patients with type 2 diabetes currently undergoing treatment with both Sitagliptin and Metformin Extended-Release Tablets [1] Group 1 - The drug is a compound formulation suitable for adult patients with type 2 diabetes [1] - The company received the drug marketing license application acceptance notice in January 2024 and has recently obtained approval from the National Medical Products Administration [1] - The approval of the drug registration certificate is considered equivalent to passing the consistency evaluation, which will further enrich the company's product pipeline [1] Group 2 - There is significant uncertainty regarding the specific sales performance of the newly approved drug [1]
汇宇制药:注射用硫酸多黏菌素B获药品注册证书
news flash· 2025-06-04 09:07
Core Viewpoint - The company has received approval for the injectable colistin sulfate from the National Medical Products Administration, indicating a significant development in its product portfolio [1] Group 1: Product Approval - The company's wholly-owned subsidiary, Sichuan Huiyu Haiyue Pharmaceutical Technology Co., Ltd., has been granted a drug registration certificate for injectable colistin sulfate [1] - Injectable colistin sulfate is classified as a Class 3 chemical drug with a specification of 500,000 units and a shelf life of 24 months [1] Group 2: Market Potential - The drug is intended for treating severe infections in adult patients caused by carbapenem-resistant Gram-negative bacteria, including meningitis and bacteremia caused by sensitive strains of Pseudomonas aeruginosa [1] - The projected sales revenue for injectable colistin sulfate in urban public hospitals in China for 2024 is estimated to be 529 million yuan [1] Group 3: Future Outlook - The company has initiated preparatory work for the product's market launch, but there is uncertainty regarding its potential to generate significant revenue in the future [1]
上海医药:温经汤颗粒获批准生产
news flash· 2025-05-14 07:34
Core Viewpoint - Shanghai Pharmaceuticals (601607) announced that its subsidiary, Shanghai Guofeng, received a drug registration certificate from the National Medical Products Administration for its product, Wengjing Decoction Granules, which is indicated for blood deficiency and stagnation [1] Group 1 - The product Wengjing Decoction Granules is designed to supplement deficiency, resolve stasis, and alleviate pain, specifically for conditions related to blood deficiency and qi stagnation [1] - The registration application for the product was submitted in July 2024 and has been accepted [1] - The company has invested approximately RMB 4.69 million in research and development for this product as of the announcement date [1] Group 2 - China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. is currently the approved manufacturer for this product [1]
海普瑞:依诺肝素钠注射液获南非药品注册批件
news flash· 2025-04-24 09:57
Core Viewpoint - The approval of Ivenoxin (enoxaparin sodium injection) by the South African Health Products Regulatory Authority is expected to enhance the sales of the product in the South African market and increase the company's global market share [1] Company Summary - The company, Haiprui (002399), announced that its wholly-owned subsidiary, Tiandao Pharmaceutical, has received the approval notification for enoxaparin sodium injection [1] - The product is available in various specifications: 0.2ml:20mg, 0.4ml:40mg, 0.6ml:60mg, 0.8ml:80mg, and 1.0ml:100mg [1] - The indications for the product include thrombosis prevention before and after surgery, reduction of thrombotic risk in acute diseases, and treatment of deep vein thrombosis [1] - The license for the product is valid for five years [1] Industry Summary - The approval is anticipated to boost the company's enoxaparin sodium formulation sales in South Africa, contributing positively to its market presence [1]
北京双鹭药业股份有限公司 关于获得硝酸甘油喷雾剂药品注册证书的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-04-08 23:09
Core Viewpoint - Beijing Shuanglu Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for its nitroglycerin spray (brand name: Lishengle), marking a significant milestone as the first domestic approval for this new dosage form [1][2]. Group 1: Drug Information - The nitroglycerin spray is classified as a chemical drug of category 4, with each bottle containing 200 sprays, and each spray delivering 0.4 mg of nitroglycerin [1][2]. - The drug acts quickly, with clinical studies showing that 23.5% of patients experience immediate effects, 62% within one minute, and up to 85.75% within two minutes [2]. - The spray is designed for emergency situations, particularly for acute angina attacks, and is noted for its safety and efficacy compared to aerosol forms, as it does not contain propellants and avoids cooling effects [2][3]. Group 2: Market Context - There are approximately 330 million cardiovascular disease patients in China, with around 11 million suffering from coronary heart disease, indicating a significant market for emergency medications like nitroglycerin [3]. - The overall market size for nitroglycerin formulations (including tablets and aerosols) is estimated to be between 1 billion to 2 billion yuan in 2023, with an expected annual growth rate of 8% to 12% due to the aging population and rising cardiovascular diseases [3]. - The newly approved nitroglycerin spray has been included in the national medical insurance category B, enhancing its market accessibility [3]. Group 3: Company Impact - The approval of the nitroglycerin spray will enrich the company's product portfolio in the cardiovascular medication sector, positioning it as the sole domestic provider of this new dosage form [3].