转自：证券日报网 本报记者许林艳 近日，南京征祥医药有限公司（以下简称"征祥医药"）官微宣布，其自主研发的新型PA抑制剂抗 流感新药济可舒（玛硒洛沙韦片）正式获得国家药品监督管理局（NMPA）批准上市，用于治疗成人单 纯性流感。 流行性感冒是由流感病毒引起的一种传染性强、传播速度快的急性呼吸道传染病。据了解，季节性 流感是全球重要的公共卫生问题，目前人群流行的流感病毒主要包括甲型流感病毒的HINI和H3N2亚 型，以及乙型流感病毒的Victoria和Yamagata谱系。 尽管近些年抗流感病毒药物已被广泛应用，但耐药性增强、患者依从性不足及胃肠道不良反应等问 题仍待解决。 3月27日，由青峰医药集团有限公司下属子公司江西科睿药业有限公司研发的玛舒拉沙韦片（商品 名：伊速达）正式获批上市。据了解，玛舒拉沙韦是我国自主研发的首个、全球第二个靶向聚合酶酸性 蛋白流感抗病毒药物，直击病毒复制的核心引擎。 据开源证券研报，截至2025年5月，中国已获批上市治疗流感病毒性感染的新药主要有10款，其中 专门作用于流感病毒性感染的药物有8款；美国已获批上市治疗流感病毒性感染的新药主要有7款，其中 专门作用于流感病毒性感染的药 ...

Group 1 - The core point of the news is the approval of the innovative anti-influenza drug Jike Shou (generic name: Marcilosavir) by the National Medical Products Administration of China, marking a significant advancement in the treatment of influenza [1] - Jike Shou is a new generation targeted RNA polymerase PA inhibitor developed independently in China, with global intellectual property rights, specifically designed to inhibit the transcription of viral mRNA, thus providing an antiviral effect [1] - The clinical research for Jike Shou was conducted primarily on Chinese patients, ensuring that the treatment is more applicable and relevant to the characteristics of the Chinese population [1] Group 2 - Jikawa Pharmaceutical (stock code: 600566) has formed a strategic partnership with Zhengxiang Pharmaceutical for the registration, production, promotion, channel management, and commercial sales of Jike Shou, granting Jikawa exclusive promotion and sales rights in China [1] - The results of the Phase II/III clinical studies for Jike Shou, conducted by leading experts in infectious diseases, have been published in the prestigious journal Clinical Microbiology and Infection, providing scientific support for its clinical application [1] - The Phase III clinical study for Jike Shou in treating uncomplicated influenza in adolescents has been submitted for market approval, and additional studies for children aged 5-11 are ongoing to address differentiated medication needs [2] Group 3 - With the normalization of flu seasons, there is a growing demand for efficient, safe, and convenient treatment options, which Jike Shou aims to fulfill [2] - The company believes that Jike Shou will offer differentiated medication choices for influenza patients, contributing Chinese wisdom to the fight against influenza and injecting new vitality into the global anti-influenza drug market [2]

Core Viewpoint - The approval of the oral antiviral drug Maraslavir (brand name: Jikeshou) by the National Medical Products Administration (NMPA) marks a significant advancement in the treatment of influenza, particularly for healthy adults with uncomplicated influenza A and B infections [1][2]. Group 1: Drug Approval and Characteristics - Maraslavir is a new generation polymerase acidic protein (PA) nuclease inhibitor with broad-spectrum antiviral properties against influenza A, B, and highly pathogenic avian influenza viruses [1]. - The drug was developed by a team led by Zhang Wenhong from the National Center for Infectious Disease Medicine and Huashan Hospital affiliated with Fudan University [1]. - Clinical data published in the journal "Clinical Microbiology and Infection" earlier this year supports the drug's efficacy and safety [1]. Group 2: Market Context and Comparisons - Maraslavir is positioned as a domestic alternative to the imported flu drug Baloxavir (brand name: Sufuda), which has raised concerns about supply shortages [2]. - Another domestic antiviral, Mashulavir (brand name: Yisuda), has also been approved for treating uncomplicated influenza in adolescents and adults [2]. - Pricing analysis shows that some newly launched domestic antiviral drugs are priced higher than their imported counterparts, with Mashulavir priced at approximately 320 yuan for 20mg*2 tablets, compared to Baloxavir's price of less than 200 yuan [2]. Group 3: Resistance and Clinical Use - Current clinical studies are addressing the resistance issues associated with existing antiviral drugs [2]. - Data indicates that Mashulavir has a low resistance mutation rate of 0.7% and 0.9% for influenza A H1N1 and H3N2 strains, respectively, with only one mutation site for H1N1 and no detected resistance mutations in influenza B patients [2].