近日，北京福元医药股份有限公司收到国家药监局颁发的坎地沙坦酯氢氯噻嗪片（Ⅱ）《药品注册证 书》，规格为每片含坎地沙坦酯16mg与氢氯噻嗪12.5mg，注册分类为化学药品3类。该药品不适用于高 血压初始治疗，适用于特定成年人原发性高血压。公司于2024年5月申报受理，此次获批视同通过一致 性评价，累计研发投入484.41万元。2024年相关复方制剂销售额约1.54亿元。此证书将丰富公司产品 线，但药品销售受多种因素影响，存在不确定性。 ...

亿帆医药9月16日晚间公告，公司全资子公司合肥亿帆生物制药有限公司获得国家药品监督管理局核准 签发的注射用硫酸艾沙康唑《药品注册证书》。注射用硫酸艾沙康唑为抗感染药物，适用于治疗成人患 者下列感染：侵袭性曲霉病、侵袭性毛霉病。截至本报告披露日，除本公司外，中国境内注射用硫酸艾 沙康唑有9家企业获批上市，另有多家企业处于仿制药报产审评中。截至本报告披露日，公司对注射用 硫酸艾沙康唑的研发投入约789.72万元。 ...

该药品本次获批上市，将进一步丰富本集团产品线。 复星医药（600196）(02196)发布公告，近日，该公司控股子公司锦州奥鸿药业有限责任公司就法莫替 丁注射液(以下简称"该药品")的药品注册申请获国家药品监督管理局批准。 该药品为本集团(即本公司及控股子公司/单位，下同)自主研发的化学药品,本次获批适应症为用于消化 性溃疡所致上消化道出血，除肿瘤及食道、胃底静脉曲张以外的各种原因所致的胃及十二指肠粘膜糜烂 出血者。 截至2025年8月，本集团现阶段针对该药品累计研发投入约为人民币767万元(未经审计)。 根据IQVIA CHPA最新数据，2024年，法莫替丁注射剂于中国境内(不包括港澳台地区)的销售额约为人 民币13.77亿元。 ...

证券代码：603168 证券简称：莎普爱思 公告编号：临 2025-048 浙江莎普爱思药业股份有限公司 关于获得硫酸特布他林雾化吸入用溶液 《药品注册证书》的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重 大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 近日，浙江莎普爱思药业股份有限公司（以下简称 "公司"、"莎普爱思"）收 到国家药品监督管理局核发的硫酸特布他林雾化吸入用溶液的《药品注册证书》（证书 编号：2025S02611），现将有关信息公告如下： 一、《药品注册证书》主要内容 药品名称：硫酸特布他林雾化吸入用溶液 剂型：吸入制剂 规格：2ml：5mg 注册分类：化学药品4类 药品批准文号：国药准字H20255228 上市许可持有人：浙江莎普爱思药业股份有限公司 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品符合药 品注册的有关要求，批准注册，发给药品注册证书。 二、药品其他情况 本次获批的硫酸特布他林雾化吸入用溶液，可缓解支气管哮喘、慢性支气管炎、肺 气肿及其它肺部疾病所合并的支气管痉挛。 截至本公告披露日，公司针对该药品的累计研发投入约 ...

Group 1 - The company announced that its subsidiary, Jiangxi Mayinglong Meikang Pharmaceutical Co., Ltd., received the drug registration certificate for Olopatadine Hydrochloride Eye Drops from the National Medical Products Administration [1][2] - The drug is indicated for the treatment of allergic conjunctivitis-related eye itching and was first approved in the United States in 2004, with the original import approval in China granted in 2020 [2] - The domestic market sales of Olopatadine Hydrochloride Eye Drops reached 255 million yuan in 2023, and the company's cumulative R&D investment for this drug is 4.9224 million yuan [2] Group 2 - The approval of the drug registration certificate will help enrich the company's ophthalmic product line [3] - The production and sales of the drug are subject to uncertainties due to industry policies and market competition [3]

Core Viewpoint - The approval of the drug "Drosperinone and Ethinyl Estradiol Tablets" by the National Medical Products Administration marks a significant milestone for the company, enabling it to sell the product in the domestic market and enhancing its product line [1] Group 1 - The company's subsidiary, Wuhan Jiulong Renfu Pharmaceutical Co., Ltd., received the drug registration certificate for Drosperinone and Ethinyl Estradiol Tablets [1] - The drug is intended for female contraception and the company submitted its application for marketing authorization in March 2024, which has been accepted [1] - The total R&D investment for this product amounts to approximately RMB 8.5 million [1] Group 2 - The projected national sales revenue for Drosperinone and Ethinyl Estradiol Tablets in 2024 is approximately RMB 320 million [1] - The approval signifies the company's qualification to market the drug domestically, which is expected to have a positive impact on its business [1]

Core Viewpoint - Fuyuan Pharmaceutical (601089) has received the drug registration certificate for Amorolfine Hydrochloride Solution from the National Medical Products Administration, indicating a significant advancement in its product portfolio aimed at treating fungal infections of nails [1] Company Summary - Fuyuan Pharmaceutical's wholly-owned subsidiary, Fuyuan Pharmaceutical Co., Ltd., has been granted the drug registration certificate for Amorolfine Hydrochloride Solution, which is intended for the treatment of nail infections caused by sensitive fungi [1] - The company received the acceptance notice for the application on January 2, 2024, and has recently obtained approval [1] - As of the announcement date, Fuyuan Pharmaceutical has invested a total of RMB 3.9783 million in the research and development of this drug [1] Industry Summary - According to data from Minet, the sales revenue of Amorolfine Hydrochloride Solution in China's three major terminal markets is estimated to be approximately RMB 456 million in 2024 [1]

Group 1 - The company, Henan Lingrui Pharmaceutical Co., Ltd., announced that its subsidiary, Yingu Pharmaceutical Co., Ltd., received a drug registration certificate from the National Medical Products Administration for a new indication of the innovative drug, Phenylquaternary Ammonium Bromide Nasal Spray, to improve symptoms of runny nose, nasal congestion, nasal itching, and sneezing caused by colds [1] - The drug is classified as a prescription medication and is categorized as a Class 2.4 chemical drug, with specifications of 5ml:5mg and 10ml:10mg [1] - The nasal spray was initially approved for marketing in March 2020 for allergic rhinitis symptoms and is the only approved anticholinergic nasal medication for this condition in China [2] Group 2 - The market size for competing drug types, including nasal corticosteroids and antihistamines, is approximately 5.4 billion RMB [2] - The newly approved indication for the nasal spray is significant as it is the first M receptor antagonist nasal spray for post-cold nasal symptoms in China, offering advantages such as convenience and high safety [2] - The total research and development investment for expanding the indication of the nasal spray has reached approximately 35.97 million RMB [2]

Core Viewpoint - The approval of Perindopril Indapamide tablets by the National Medical Products Administration enhances the product portfolio of the company in the cardiovascular field and strengthens its market competitiveness [1] Group 1 - The company's wholly-owned subsidiary, China National Pharmaceutical Group Industrial Co., Ltd., received the drug registration certificate for Perindopril Indapamide tablets [1] - The drug is a compound tablet consisting of Perindopril tert-butylamine and Indapamide, intended for the treatment of primary hypertension in adults [1] - The projected sales revenue for Perindopril Indapamide tablets in public medical institutions and urban pharmacies across the country in 2024 is estimated to be 269 million yuan [1] Group 2 - The cumulative research and development investment for this project by the company amounts to approximately 18.568 million yuan [1] - The approval of this drug will enrich the company's formulation product line in the cardiovascular sector [1] - The new product is expected to enhance the company's competitiveness in the market [1]

Core Viewpoint - The company Shapais (603168) has received approval from the National Medical Products Administration for its polyethylene glycol eye drops, which can be used to prevent or treat symptoms such as dry eyes, foreign body sensation, and eye fatigue [1] Summary by Relevant Categories Product Approval - The polyethylene glycol eye drops are classified as an ophthalmic preparation with a specification of 1.4% (0.4 ml: 5.6 mg) [1] - The approval signifies a significant milestone for the company in expanding its product offerings in the ophthalmic market [1] Research and Development Investment - The cumulative R&D investment for this product has reached approximately 8.11 million RMB [1] - This investment reflects the company's commitment to developing innovative solutions for eye care [1]