一、药品的基本情况 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，马应龙药业集团股份有限公司（以下简称"公司"或"本公司"）子公司江西马应龙美康药业有限公 司（以下简称"马应龙美康"）收到国家药品监督管理局核准签发的盐酸奥洛他定滴眼液（以下简称"该 药品"）《药品注册证书》（证书编号：2025S02553），现就相关情况公告如下： 药品名称：盐酸奥洛他定滴眼液 剂型：眼用制剂 规格：0.2%（2.5ml：5mg，按C21H23NO3计） 注册分类：化学药品4类 药品注册标准编号：YBH20042025 处方药/非处方药：处方药 上市许可持有人：江西马应龙美康药业有限公司 三、对公司的影响及风险提示 此次该药品获批《药品注册证书》有助于进一步丰富公司眼科产品线。由于药品生产、销售受医药行业 政策、市场竞争状况等因素影响存在不确定性，敬请广大投资者谨慎决策，注意防范投资风险。 特此公告。 马应龙药业集团股份有限公司董事会 生产企业：浙江尖峰药业有限公司 药品批准文号：国药准字H20255181 药品批准文号有效期：至203 ...

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]

莎普爱思（603168）公告，近日公司收到国家药品监督管理局核准签发的聚乙烯醇滴眼液《药品注册证 书》。该药品剂型为眼用制剂，规格为1.4%(0.4毫升：5.6毫克)。截至本公告披露日，公司针对该药品 的累计研发投入约为811.27万元人民币。本次获批的聚乙烯醇滴眼液，可作为一种润滑剂预防或治疗眼 部干涩、异物感、眼疲劳等刺激症状或改善眼部的干燥症状。 ...