Workflow
流感病毒
icon
Search documents
步长制药:控股子公司获得四价流感病毒裂解疫苗药品注册证书
news flash· 2025-07-11 09:38
步长制药(603858)公告,控股子公司浙江天元生物药业有限公司近日收到国家药品监督管理局核准签 发的关于四价流感病毒裂解疫苗的《药品注册证书》。该疫苗主要用于刺激机体产生抗流行性感冒病毒 的免疫力,预防本毒株引起的流行性感冒。截至2025年6月30日,公司在四价流感病毒裂解疫苗项目上 投入的研发费用约为1.26亿元。 ...
新里程董事长被实施留置;腾盛博药与健康元就在研药达成许可协议
Mei Ri Jing Ji Xin Wen· 2025-07-06 23:21
Group 1 - Lin Yanglin, the chairman of Xinlicheng, has been placed under detention and is under investigation, which may impact investor confidence despite the company stating the matter is unrelated to its operations [1] - Weiming Pharmaceutical's stock will be suspended for one day due to its trial progress not meeting expectations and its subsidiary's inability to resume normal operations within three months, affecting performance expectations [2] - Tengsheng Bo Pharmaceutical has signed a licensing agreement with Health Yuan Group for the exclusive rights to research, develop, and commercialize BRII-693 in China, providing cash flow and enhancing market expectations [3] Group 2 - China Resources Double Crane announced a cash dividend of 3.71 yuan per 10 shares despite a decline in revenue and net profit, indicating strong cash flow and commitment to shareholders [4] - InnoTech's subsidiary has obtained long-term product certification for a flu detection kit, which is expected to enhance market competitiveness and potentially increase revenue [5]
华兰生物回应流感疫苗失去世卫预认证资格:因原车间不再使用,计划提交新申请
Xin Lang Cai Jing· 2025-07-02 08:04
智通财经记者 | 李科文 智通财经编辑 | 谢欣 7月2日,智通财经记者获悉,在最新的世界卫生组织预认证列表中,华兰生物流感疫苗已被剔除。 对此,7月2日,华兰生物向智通财经记者回应称,原有通过世界卫生组织预认证(三价流感疫苗,西林瓶包装)的2#车 间从建设至今已18年,计划不再使用,因此向世界卫生组织正式提交了将流感疫苗撤出世卫组织预认证清单的申请,后 续华兰疫苗计划重新提交新车间预认证PQ申请。撤回预认证PQ申请,对公司海外销售及业绩不会造成影响。 华兰生物表示,华兰疫苗目前正常生产流感病毒裂解疫苗(三价)和四价流感裂解疫苗的车间为2021年后投入使用的 3/4/5/6#新生产车间,其生产规模具备年产流感疫苗1亿人份。 世界卫生组织预认证是2001年启动的联合国行动计划,用于扩大选择的优先药物的获取,目标是确保国际基金(如全球 基金GFTAM、联合国援助国际药品采购机制UNITAID)采购药品的质量、疗效和安全性,服务发展中国家的患者。 疫苗预认证是世界卫生组织预认证中非常重要的组成部分,是世界卫生组织为保证疫苗产品的质量、安全性和有效性达 到国际标准而进行的一项评估认证工作,为联合国采购机构疫苗采购提供 ...
全国首个疫苗检验中心在建,有望推动创新疫苗加速上市
Xiangcai Securities· 2025-06-29 09:50
证券研究报告 2025 年 06 月 29 日 湘财证券研究所 行业研究 疫苗行业周报 全国首个疫苗检验中心在建,有望推动创新疫苗加速上市 相关研究: 1. 《三级医院设立公共卫生/预 防保健科,助力医防融合的推进》 20250615 2. 《多项政策推动疫苗创新》 20250622 行业评级:增持(维持) 近十二个月行业表现 -20 -10 0 10 20 30 24/07 24/10 25/01 25/04 沪深300_累计 疫苗_累计 证书编号:S0500517110001 Tel:021-50293534 Email:xw3315@xcsc.com 地址:上海市浦东新区银城路88号 中国人寿金融中心10楼 核心要点 医疗保障法草案首次亮相。《中华人民共和国医疗保障法(草案)》6 月 24 日 提请十四届全国人大常委会第十六次会议首次审议。草案共 7 章 50 条,系统 规定医疗保障体系框架、加强医疗保障基金运行管理、优化医疗保障服务、 强化监督管理。草案中提出,发生重大传染病疫情等紧急情况时,国务院医 疗保障行政部门在听取国务院卫生健康、中医药、疾病预防控制、工业和信 息化等部门意见的基础上,可以会同 ...
步长制药:入选药智网双榜TOP50,持续推动研发彰显卓越实力
Cai Jing Wang· 2025-06-24 08:25
Core Insights - The "2025 PDI Pharmaceutical R&D and Innovation Conference" has commenced, unveiling the "2025 China Biopharmaceutical R&D Strength Ranking TOP50" and "2025 China Traditional Chinese Medicine R&D Strength Ranking TOP50" [1] - The rankings are initiated by professional organizations like Yaowang Network, which has established a mature and authoritative evaluation system in the pharmaceutical and health industry since its first release in 2016 [1] - Bichang Pharmaceutical, a leading enterprise in traditional Chinese medicine focusing on cardiovascular and cerebrovascular products, has been recognized for its outstanding R&D capabilities [1] Company Overview - Bichang Pharmaceutical has built a sustainable development model centered on R&D, focusing on major diseases and cultivating significant products across various fields including traditional Chinese medicine, chemical drugs, biopharmaceuticals, vaccines, and medical devices [3][4] - The company reported a total sales revenue of 5.83 billion yuan from three proprietary traditional Chinese medicines in the cardiovascular field, which consistently rank among the top 20 in the market share for traditional Chinese medicine in public medical institutions [3] R&D and Product Pipeline - Bichang Pharmaceutical is actively developing 12 biopharmaceutical products, with some entering the NDA application stage, supported by high-level academic platforms such as academician and doctoral workstations [4] - The vaccine segment includes four products, with several others under development, showcasing the company's differentiated competitive edge [4] - The company has a total of 213 products in its pipeline, demonstrating its comprehensive layout and exceptional strength across traditional Chinese medicine, chemical drugs, biopharmaceuticals, and vaccines [4] Financial Performance and Social Responsibility - Since its listing in 2016, Bichang Pharmaceutical has distributed over 7.5 billion yuan in dividends, with an average dividend rate exceeding 85%, reflecting its commitment to shareholder returns and financial resilience [5] - The company has paid nearly 32 billion yuan in taxes and has been actively involved in social welfare projects, significantly contributing to healthcare improvements in remote areas [5] - Bichang Pharmaceutical aims to enhance its R&D investments and contribute to national pharmaceutical advancements and public health, aligning with its philosophy of giving back to society [5]
国家药监局公布5起“清源”行动违法违规案例丨21健讯Daily
Group 1 - Fujian Quanzhou has launched an instant settlement model for basic medical insurance funds to improve settlement efficiency and alleviate financial pressure on designated medical institutions [1] - The instant settlement reform establishes an efficient mechanism of "daily payment + monthly settlement" by compressing the settlement cycle and increasing payment frequency [1] Group 2 - Shanghai Pharmaceuticals announced that its subsidiary in Thailand received approval from the Thai FDA for the registration of Pregabalin capsules, which are used to treat various types of neuropathic pain and as an adjunct therapy for epilepsy [3] - Gilead Sciences announced that the FDA approved its injectable HIV-1 capsid inhibitor Yeztugo for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV infection in adults and adolescents weighing 35 kg or more [4] Group 3 - Haizheng Pharmaceutical plans to establish a joint venture for synthetic biology with its wholly-owned subsidiary, with a registered capital of 350 million yuan, aiming to support the professional and large-scale development of its synthetic biology business [6] - Nuo Vision announced a plan to repurchase shares worth between 5 million and 10 million yuan for employee stock ownership plans, with a repurchase price not exceeding 30 yuan per share [7] - Tiankang Biological's subsidiary Tiankang Pharmaceutical has completed the counseling acceptance for its public stock issuance and listing on the Beijing Stock Exchange [8] Group 4 - Baike Biological received approval from the National Medical Products Administration for clinical trials of its influenza virus split vaccine, which aims to provide new vaccination options for individuals aged 60 and above [10] - Dizhi Pharmaceutical announced the completion of patient enrollment for its global Phase III clinical study of its lung cancer targeted drug, which compares its drug with platinum-based chemotherapy for advanced non-small cell lung cancer [11] Group 5 - The FDA announced the launch of the "Commissioners National Priority Voucher" program to expedite new drug review times from approximately 10-12 months to 1-2 months for eligible companies [12] - Shengnuo Biological expects a net profit increase of 254% to 332% year-on-year for the first half of 2025, driven by strong performance in its peptide raw material business [12]
6月19日重要资讯一览
重要的消息有哪些 商务部:将依法依规不断加快对稀土相关出口许可申请的审查 在19日商务部举行的例行发布会上,新闻发言人何亚东谈到稀土相关出口问题时表示,将依法依规不断 加快对稀土相关出口许可申请的审查。 商务部新闻发言人何亚东表示,中国一贯高度重视维护全球产供链的稳定与安全,依法依规不断加快对 稀土相关出口许可申请的审查,已经依法批准一定数量的合规申请,并将持续加强合规申请的审批工 作。中方愿就此进一步加强与相关国家的出口管制沟通对话,积极促进便利合规贸易。 美国可能对伊朗进行打击?中方回应 6月19日,外交部发言人郭嘉昆主持例行记者会。有记者提问,据彭博社报道,美国官员正在为未来几 天可能对伊朗的打击做准备。中方对此有何评论? 郭嘉昆表示,当前中东地区局势紧张敏感,面临失控的风险,中方反对任何违反联合国宪章宗旨和原 则、侵犯别国主权安全和领土完整的行为,反对在国际关系中使用或威胁使用武力。国际社会特别是有 影响力的大国,应秉持公正立场和负责任态度,为推动停火止战、重回对话谈判创造条件,避免地区局 势滑向深渊,引发更大的灾难。 近日,在中国证监会指导下,上交所制定完成《推动提升沪市上市公司ESG评级专项行动方 ...
百克生物:流感病毒裂解疫苗(BK-01佐剂)临床试验申请获批
news flash· 2025-06-19 08:28
百克生物公告,公司近日收到国家药品监督管理局下发的流感病毒裂解疫苗(BK-01佐剂)的《药物临床 试验批准通知书》。该疫苗接种对象为60岁及以上人群,用于预防流感病毒引发的流行性感冒。疫苗采 用流感病毒裂解疫苗工艺技术路线,配伍以公司自主研发的佐剂,提高疫苗免疫原性。若该疫苗成功开 发,将完善公司流感疫苗研发管线,为60岁及以上人群提供新的接种选择。 ...
步长制药:中期分红议案落地 同投资者共享企业发展红利
Cai Jing Wang· 2025-06-16 06:40
多业务赛道并行发展,打造全方位医药产业矩阵 步长制药(603858.SH)于5月27日审议通过了《关于公司2025年中期分红安排的议案》,将加大投资者回报力度,分享经营成果,提振投资者的持股信心。此 次分红为公司上市来首次进行中期分红,一方面体现公司积极响应新"国九条"号召,把回报投资者落在实处,另一方面也反映公司管理层对公司未来持续高 质量发展的坚定信心。作为国内中医药龙头企业,步长制药从持续回馈股东,到深入履行社会责任,再到全方位业务矩阵,探索出一条兼具经济效益与社会 价值的发展路径。 注重投资者回报,多次分红回馈投资者 近期,新"国九条"的发布强化了上市公司现金分红监管,提出增强分红稳定性、持续性和可预期性,同时证监会配套政策鼓励中期分红、春节前分红等创新 形式。在此背景下,多家企业纷纷加入多次分红行列,让投资者切实享受到企业的发展红利。 自上市多年以来,步长制药始终注重投资者回报,亦积极加入到多次分红的行列,公司已于近日落地中期分红议案;同时,Wind数据显示,自2016年上市 以来,公司累计分红超75亿元,平均分红率超85%,远超募集资金,派息融资比接近200%。 另外,步长制药于今年4月份加大回购 ...
赛诺菲恢复四价流感疫苗在华销售,公司称不对产品价格做调整
Di Yi Cai Jing· 2025-06-13 10:18
Core Viewpoint - Sanofi has resumed the sale of its quadrivalent influenza vaccine in China after a nine-month suspension, with the vaccine for the 2025-2026 flu season receiving approval from the Chinese drug regulatory authority [1][3]. Group 1: Vaccine Production and Sales - Sanofi paused the sales of its trivalent and quadrivalent influenza vaccines for the 2024-2025 flu season due to a decline in vaccine efficacy observed during stability assessments [3]. - The company has optimized the immunogenicity and product stability evaluation for the 2025-2026 flu season, completing pilot production of the vaccine in December 2024, with all results indicating stable efficacy [3]. Group 2: Market Dynamics and Pricing - The influenza vaccine market in China is highly competitive, with many manufacturers and a historically low vaccination rate, often remaining in single digits [3]. - Despite other manufacturers reducing prices for influenza vaccines, Sanofi has decided not to adjust the price of its quadrivalent influenza vaccine, citing factors such as exchange rates and production costs [1][3].