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股市必读:众生药业(002317)10月14日董秘有最新回复
Sou Hu Cai Jing· 2025-10-14 20:26
董秘: 您好!公司重视药品的国外市场机会,积极寻求国际合作。如达到相关披露标准,公司将严格 根据信息披露规则及时履行信息披露义务。谢谢! 投资者: 公司昂拉地韦、RAY1225海外BD进展如何?年底能不能落地? 截至2025年10月14日收盘,众生药业(002317)报收于16.56元,下跌1.02%,换手率3.3%,成交量25.11万 手,成交额4.22亿元。 董秘最新回复 投资者: 董秘你好,作为国际化进度为0的企业,全部国际化全靠说大话的企业,请问近期贸易战导致 资本市场动荡为何会影响到贵公司? 董秘: 您好,公司不存在您所述情况,公司始终积极关注各类市场机会,相关进展若达披露标准将及 时公告。谢谢! 投资者: 董秘你好,贵公司吹嘘的昂拉地韦首创的pb2靶点创新药,为何无法再医院、药店推广? 董秘: 不存在您所述情况。谢谢! 投资者: 流感季即将爆发,对公司昂拉地韦的销售是否有促进作用?公司是否为流感季做好了销售准 备? 董秘: 您好!公司的昂拉地韦片(商品名:安睿威)适用于成人单纯性甲型流感患者的治疗,临床前 研究结果表明,对包括奥司他韦耐药株、高致病性禽流感病毒株和巴洛沙韦耐药株等在内的多种不同亚 ...
一品红(300723.SZ)全资子公司获得磷酸奥司他韦胶囊药品补充申请批准通知书
Ge Long Hui A P P· 2025-09-19 04:07
格隆汇9月19日丨一品红(300723.SZ)公布,公司全资子公司广州一品红制药有限公司(以下简称"一品红 制药")于近日收到国家药品监督管理局核准签发的关于磷酸奥司他韦胶囊的《药品补充申请批准通知 书》。 根据《中华人民共和国药品管理法》及有关规定,经审查,本品此次申请事项符合药品注册的有关要 求,同意本品增加45mg 规格,核发药品批准文号。同时批准如下关联补充申请事项:1、变更处方中 的辅料用量;2、变更包装材料和容器;3、注册标准变更。变更后的生产工艺及质量标准照所附执行, 有效期 12 个月,说明书及包装标签做相应修订,其他执行原批准信息。 磷酸奥司他韦为神经氨酸酶(NA)抑制剂,其作用机理为选择性抑制神经氨酸酶的活性,阻止病毒由被 感染细胞释放和入侵邻近细胞,减少病毒在体内的复制,从而抑制流感病毒在人体内的传播以起到治疗 流行性感冒的作用。磷酸奥司他韦为世界卫生组织(WHO)推荐的基本药物,被美国和欧洲疾病预防控 制中心推荐为主要的抗流感病毒药物,同时也是《流行性感冒诊疗方案(2025年版)》明确的一线抗流感 病毒药物。 磷酸奥司他韦胶囊是属于国家医保乙类产品,并进入中国2018版基药目录。公司获 ...
抗流感新药加速上市 市场格局生变
Zheng Quan Ri Bao· 2025-07-21 12:18
Core Insights - Nanjing Zhengxiang Pharmaceutical's new flu drug, Jikeshou (Maseiluo Shave Tablets), has been approved by the National Medical Products Administration (NMPA) for treating adult uncomplicated influenza, marking a significant advancement in antiviral treatments [1][2] - The flu remains a major public health issue globally, with prevalent strains including H1N1, H3N2, and various B virus lineages [1] - The market for antiviral drugs in China is expected to grow significantly, with projections estimating a market size of 11.6 billion yuan by 2030 [4] Company Developments - Zhengxiang Pharmaceutical's Jikeshou is a new generation PA inhibitor targeting flu virus RNA polymerase, demonstrating prolonged antiviral activity [2] - Other companies, such as Guangdong Zhongsheng Pharmaceutical and Qingfeng Pharmaceutical Group, have also launched new antiviral drugs, including Angladiwei and Mashulashave, which target different mechanisms of flu virus replication [2] Market Trends - The antiviral drug market in China is experiencing a shift from traditional neuraminidase inhibitors, like Oseltamivir, which currently holds over 80% market share, to RNA polymerase inhibitors, which are gaining traction [4] - The domestic flu drug market exceeded 10 billion yuan in 2023, with significant growth observed in sales of newer drugs like Mabalosave, which increased from 70 million yuan in 2022 to 630 million yuan in 2023 [4] - The competitive landscape is evolving, with potential price wars emerging as new entrants challenge established products, although differentiation in efficacy and safety may mitigate risks of homogenization [4]
1类创新药济可舒获批上市
Zhong Zheng Wang· 2025-07-18 10:44
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]
又一款“全程一次用药”的国产流感口服药上市,张文宏团队牵头研发
第一财经· 2025-07-18 08:20
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].