富马酸比索洛尔片
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多家医药上市公司相关产品获得药品注册证书
Zheng Quan Shi Bao Wang· 2025-10-13 11:20
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]
新华制药获富马酸比索洛尔片药品注册证书
Zhi Tong Cai Jing· 2025-10-13 09:33
Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the marketing of Fumarate Bisoprolol Tablets, which are indicated for hypertension, coronary heart disease (angina), and chronic stable heart failure with reduced left ventricular systolic function (ejection fraction ≤ 35%) [1] Summary by Category Product Approval - The approval includes the issuance of a Drug Registration Certificate for Fumarate Bisoprolol Tablets [1] - The product is intended for use under medical supervision alongside ACE inhibitors, diuretics, and selectively used cardiac glycosides [1] Indications - Fumarate Bisoprolol Tablets are indicated for the treatment of: - Hypertension - Coronary heart disease (angina) - Chronic stable heart failure with reduced left ventricular systolic function (ejection fraction ≤ 35%) [1]
新华制药(000756.SZ)获富马酸比索洛尔片药品注册证书
智通财经网· 2025-10-13 09:32
Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the registration certificate of Fumarate Bisoprolol Tablets, indicating a significant advancement in its product portfolio [1] Group 1: Product Approval - The Fumarate Bisoprolol Tablets are indicated for the treatment of hypertension and coronary heart disease (angina) [1] - The product is also indicated for chronic stable heart failure with reduced left ventricular systolic function (ejection fraction ≤ 35%) [1] - The use of this medication requires adherence to medical advice, including the use of ACE inhibitors, diuretics, and selectively using cardiac glycosides [1]
新华制药(000756.SZ):获得富马酸比索洛尔片药品注册证书
Ge Long Hui A P P· 2025-10-13 09:10
Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received the drug registration certificate for Fumarate Bisoprolol Tablets from the National Medical Products Administration, indicating a significant advancement in its product portfolio [1] Group 1: Product Approval - The approval is for Fumarate Bisoprolol Tablets, which are indicated for hypertension and coronary heart disease (angina) [1] - The product is also indicated for chronic stable heart failure with reduced left ventricular systolic function (ejection fraction ≤ 35%) [1] Group 2: Treatment Guidelines - The use of Fumarate Bisoprolol Tablets should be accompanied by ACE inhibitors, diuretics, and selectively used cardiac glycosides as per medical advice [1]
新华制药:获得富马酸比索洛尔片药品注册证书
Xin Lang Cai Jing· 2025-10-13 09:00
Core Viewpoint - The announcement indicates that Xinhua Pharmaceutical has received approval from the National Medical Products Administration for the registration of Fumarate Bisoprolol tablets, which are indicated for hypertension, coronary heart disease (angina), and chronic stable heart failure with reduced left ventricular systolic function (ejection fraction ≤ 35%) [1] Group 1 - The approved drug, Fumarate Bisoprolol, targets specific cardiovascular conditions [1] - The estimated sales revenue for Fumarate Bisoprolol tablets in Chinese public medical institutions is approximately RMB 1.228 billion in 2024 [1]
山东新华制药股份(00719)获得富马酸比索洛尔片药品注册证书
Zhi Tong Cai Jing· 2025-10-13 08:49
Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received the drug registration certificate for Fumarate Bisoprolol Tablets from the National Medical Products Administration, enhancing its cardiovascular product line and providing more options for clinical medication [1]. Group 1 - The company has been approved for the registration of Fumarate Bisoprolol Tablets [1]. - This approval enriches the company's cardiovascular product offerings [1]. - The new product provides additional choices for clinical medication [1].
山东新华制药股份(00719.HK):获得富马酸比索洛尔片药品注册证书
Ge Long Hui· 2025-10-13 08:49
Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of Fumaric Acid Bisoprolol Tablets, indicating a significant advancement in its product portfolio and potential market impact [1] Group 1: Product Approval and Registration - The company has been granted a drug registration certificate for Fumaric Acid Bisoprolol Tablets, confirming compliance with the relevant drug registration requirements [1] - The registration process included submission of application materials to the Center for Drug Evaluation (CDE) in February 2024, with approval granted in October 2025 [1] Group 2: Indications and Usage - Fumaric Acid Bisoprolol Tablets are indicated for hypertension, coronary heart disease (angina), and chronic stable heart failure with reduced left ventricular systolic function (ejection fraction ≤ 35%) [1] - The use of this medication should be accompanied by ACE inhibitors, diuretics, and selectively used cardiac glycosides as per medical advice [1] Group 3: Market Potential - The drug is classified as a Category A product in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2024 edition) [1] - Estimated sales for Fumaric Acid Bisoprolol Tablets in Chinese public medical institutions are projected to be approximately RMB 1.228 billion in 2024 [1]
山东新华制药股份获得富马酸比索洛尔片药品注册证书
Zhi Tong Cai Jing· 2025-10-13 08:46
Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration certificate of Fumaric Acid Bisoprolol Tablets, enhancing its cardiovascular product line and providing more options for clinical medication [1] Company Summary - The approval of Fumaric Acid Bisoprolol Tablets enriches the company's cardiovascular product offerings [1] - This development indicates the company's commitment to expanding its portfolio in the cardiovascular sector [1] Industry Summary - The approval reflects ongoing regulatory support for new pharmaceutical products in the cardiovascular market [1] - The introduction of new medications can lead to increased competition and innovation within the cardiovascular treatment landscape [1]
兄弟科技:在制剂方面,公司已拥有富马酸比索洛尔片、拉考沙胺注射液两个产品注册证书
Mei Ri Jing Ji Xin Wen· 2025-08-01 08:08
Group 1 - The company is involved in the pharmaceutical sector, focusing on the research, development, production, and sales of active pharmaceutical ingredients (APIs) and formulations [2] - In the area of APIs, the company's main products are iodine contrast agents, specifically iopamidol and iohexol, which have obtained registration certificates in China, India, Japan, and CEP certification [2] - The company has two formulation products with registration certificates: bisoprolol fumarate tablets and lacosamide injection, with the former already in market promotion and industrialization [2]
兄弟科技(002562) - 2025年7月16日投资者关系活动记录表
2025-07-17 09:48
Group 1: Company Overview and R&D - The company’s R&D expenses for 2024 are expected to increase by 10% year-on-year, focusing on the development of raw materials and formulations, as well as process optimization and technological innovation for mature products like vitamins [1] - The company has officially started selling para-hydroxyphenol in the PEEK field and is actively promoting its products, having completed sample submissions to major domestic PEEK manufacturers, currently in various validation stages [1] Group 2: Product Registration and Market Activities - The company holds registration certificates for two products: Fumaric Acid Bisoprolol Tablets and Lacosamide Injection, with the former having commenced market promotion and industrialization in 2024 [1] - There are currently no plans for stock incentive programs or share buybacks, although the company previously repurchased shares in 2019 and conducted a restricted stock incentive plan in 2015, along with the first employee stock ownership plan launched in 2021 [2] Group 3: Inventory and Capital Expenditure - The company’s large ending inventory balance is attributed to its diverse business segments, including vitamins, flavors, raw materials, leather chemicals, and chromium salts, consisting mainly of raw materials, work-in-progress, and finished products to meet varying customer demands [2] - Future capital expenditures will primarily focus on new project construction, such as a 600-ton iodinated contrast agent raw material project, and technological upgrades to existing projects aimed at cost reduction, efficiency enhancement, and improved safety and environmental control [2] Group 4: Risk Management - The company has not engaged in hedging activities and currently sees no demand for such services [2]