药品获批

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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].