ZHIFEI-BIOL(300122)

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智飞生物:15价肺炎球菌结合疫苗申请生产注册获受理
快讯· 2025-06-05 10:31
智飞生物(300122)公告,全资子公司智飞绿竹研发的15价肺炎球菌结合疫苗申请生产注册获得国家药 品监督管理局出具的《受理通知书》。该疫苗为预防用生物制品,涵盖亚洲地区检出率最高的15种血清 型,用于预防相关血清型肺炎球菌所致疾病。截至公告披露日,尚无其他15价肺炎球菌结合疫苗获批上 市。15价肺炎球菌结合疫苗申请生产注册获得受理符合疫苗多联多价研究方向,若项目进展顺利,将与 公司已经上市的23价肺炎球菌多糖疫苗、现处于I/II期临床试验阶段的26价肺炎球菌结合疫苗形成协同 效应,进一步夯实公司肺炎疫苗矩阵,强化公司的市场地位,提升公司竞争力。 ...
智飞生物(300122) - 关于15价肺炎球菌结合疫苗申请生产注册获得受理的公告
2025-06-05 10:28
证券代码:300122 证券简称:智飞生物 公告编号:2025-31 重庆智飞生物制品股份有限公司 关于 15 价肺炎球菌结合疫苗申请生产注册获得受理的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚 假记载、误导性陈述或重大遗漏。 重庆智飞生物制品股份有限公司(以下简称"公司")于近日获悉,由全资子 公司北京智飞绿竹生物制药有限公司(以下简称"智飞绿竹")研发的 15 价肺炎 球菌结合疫苗申请生产注册获得国家药品监督管理局出具的《受理通知书》(受 理号:CXSS2500059)。现将相关情况公告如下: 一、研发项目简介 肺炎链球菌是引起婴幼儿和老年人急性呼吸道感染的主要病原菌。肺炎链 球菌不仅能引起肺炎,还能导致气管炎、中耳炎、鼻窦炎、脑膜炎、菌血症等疾 病。根据全球疾病负担(GBD)研究,2021 年,肺炎链球菌是全球导致下呼吸 道感染发病和死亡比例最高的病原体,估计导致 9790 万发病病例和 50 万死亡 病例。该疾病临床治疗以抗生素为主,由于抗生素的广泛应用,肺炎链球菌的耐 药性问题日益严重。基于此,WHO 将在全球接种肺炎疫苗以预防肺炎链球菌感 染所致疾病列为优先任务。 智飞 ...
智飞生物:四价流脑结合疫苗申请生产注册获受理
快讯· 2025-05-30 11:08
Core Viewpoint - The company announced that its wholly-owned subsidiary, Zhifei Green Bamboo, has received a "Notice of Acceptance" from the National Medical Products Administration for the production registration of the ACYW135 group meningococcal polysaccharide conjugate vaccine (quadrivalent meningococcal vaccine) [1] Group 1: Product Development - Currently, there is only one quadrivalent meningococcal vaccine available in the domestic market [1] - If the vaccine is approved for market sale, it will create a synergistic effect with the company's existing meningococcal vaccine products, strengthening the company's vaccine portfolio [1] Group 2: Market Position - The approval will enhance the company's market position and competitiveness in the meningococcal vaccine sector [1] Group 3: Financial Impact - The acceptance of the production registration application will not have a significant impact on the company's short-term performance due to the high investment, long development cycle, and associated risks in drug development [1]
智飞生物(300122) - 关于四价流脑结合疫苗申请生产注册获得受理的公告
2025-05-30 11:04
证券代码:300122 证券简称:智飞生物 公告编号:2025-30 重庆智飞生物制品股份有限公司 关于四价流脑结合疫苗申请生产注册获得受理的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚 假记载、误导性陈述或重大遗漏。 重庆智飞生物制品股份有限公司(以下简称"公司")于近日获悉,由全资子 公司北京智飞绿竹生物制药有限公司(以下简称"智飞绿竹")研发的 ACYW135 群脑膜炎球菌多糖结合疫苗(以下简称"四价流脑结合疫苗")申请生产注册获得 国家药品监督管理局出具的《受理通知书》(受理号:CXSS2500056)。现将相 关情况公告如下: 一、研发项目简介 流行性脑脊髓膜炎是由脑膜炎奈瑟菌引起的急性化脓性脑膜炎,具有起病 急、进展快、传染性强、病死率高、致残率高等特点。智飞绿竹研发的四价流脑 结合疫苗为预防用生物制品,可以预防由 A、C、Y、W135 群脑膜炎球菌引起的 流行性脑脊髓膜炎。 二、获得受理的意义 截至本公告披露日,经查询国家药品监督管理局网站,国内有 1 款四价流脑 结合疫苗上市。 公司是国内流脑类疫苗产品种类较为完善的公司之一,现已搭建起流脑疫 苗矩阵。若未来该疫苗获批 ...
智飞生物(300122) - 关于公司控股股东部分股份质押的公告
2025-05-20 10:28
证券代码:300122 证券简称:智飞生物 公告编号:2025-29 重庆智飞生物制品股份有限公司 关于公司控股股东部分股份质押的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚 假记载、误导性陈述或重大遗漏。 重庆智飞生物制品股份有限公司(以下简称"公司")近日接到公司控股 股东、实际控制人蒋仁生先生的通知,获悉蒋仁生先生将其所持有的本公司部 分股份进行了质押,具体事项如下: 一、控股股东股份质押的基本情况 | 股东 名称 | 是否为 控股股 东或第 一大股 | 本次质押 股数 | 占其所 持股份 比例 | 占公司 总股本 比例 | 是否 为限 | 是否 为补 充质 | 质押起始日 质押到期日 | 质权人 | 质押 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 东及其 | (股) | | | 售股 | | | | 用途 | | | 一致行 | | (%) | (%) | | 押 | | | | | | 动人 | | | | | | | | | | | | | | | | | | 重庆农 村商业 | ...
智飞生物:吸附无细胞百白破(组分)b型流感嗜血杆菌(结合)联合疫苗获得临床试验批准
快讯· 2025-05-16 13:09
Core Viewpoint - Zhifei Biological's subsidiary has received approval for clinical trials of a combined vaccine, which is expected to enhance vaccination compliance and reduce the number of doses required [1] Group 1: Company Developments - Zhifei Biological announced that its subsidiary, Zhifei Lvzhu, has obtained the clinical trial approval for an acellular combined vaccine targeting whooping cough, diphtheria, tetanus, and type B Haemophilus influenzae [1] - The approval from the National Medical Products Administration is a significant step in the company's product development strategy [1] - The clinical trial is not expected to have a major impact on the company's recent performance, but successful product development could enhance the company's product portfolio and profitability [1]
智飞生物(300122) - 关于公司吸附无细胞百白破(组分)b 型流感嗜血杆菌(结合)联合疫苗获得临床试验批准通知书的公告
2025-05-16 13:00
证券代码:300122 证券简称:智飞生物 公告编号:2025-28 重庆智飞生物制品股份有限公司 关于吸附无细胞百白破(组分)b 型流感嗜血杆菌(结合) 联合疫苗获得临床试验批准通知书的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚 假记载、误导性陈述或重大遗漏。 重庆智飞生物制品股份有限公司(以下简称"公司")于近日获悉,由全资子 公司北京智飞绿竹生物制药有限公司(以下简称"智飞绿竹")研发的吸附无细胞 百白破(组分)b 型流感嗜血杆菌(结合)联合疫苗(以下简称"组分百白破-Hib 四联疫苗")获得国家药品监督管理局药物临床试验批准通知书(通知书编号: 2025LP01316),同意开展预防百日咳杆菌、白喉杆菌、破伤风梭状芽孢杆菌及 b 型流感嗜血杆菌引起的感染性疾病的临床试验。公司将根据临床试验批准通知 书的要求,尽快开展相关临床试验工作。 一、研发项目简介 百日咳是由百日咳杆菌引起的一种传染性极强的急性呼吸系统疾病。百日咳 在我国一年四季均可发病,春夏季发病较多,农村发病率高于城市。白喉是由白 喉杆菌所引起的一种急性呼吸道传染病,以发热,气憋,声音嘶哑,咳嗽,咽、 扁桃体及其周 ...
智飞生物2024年度业绩说明会:研发创新稳步推进 积极应对化解经营风险
Quan Jing Wang· 2025-05-13 04:36
Core Viewpoint - Despite facing significant pressure on revenue and net profit in 2024 due to industry adjustments and changes in consumer demand, the company is determined to transform into a comprehensive biopharmaceutical enterprise through innovation, optimized strategies, and international collaboration [1] Group 1: Innovation and Product Development - The company has achieved key breakthroughs in its vaccine pipeline, including the approval of a quadrivalent influenza vaccine and the acceptance of the application for a human diploid rabies vaccine [2] - The company aims to launch 1-2 self-developed products annually over the next 2-3 years to optimize its revenue structure [2] - The metabolic disease treatment sector is emerging as a new growth area, with significant progress in GLP-1 and insulin analogs, including the submission of liraglutide for market approval [2] Group 2: Risk Management Strategies - The company has implemented various measures to mitigate operational risks since the second quarter of the previous year, including enhancing communication with partners and adjusting promotional policies [3] - The company is focusing on inventory management and has initiated a "de-inventory" campaign to improve sales and reduce operational risks [4] - As of the end of Q1 2024, the company's accounts receivable have decreased to 14.6 billion, with ongoing efforts to manage aging receivables [4] Group 3: Shareholder Returns and Future Outlook - The company has prioritized shareholder returns by implementing a mid-term dividend of 479 million and completing over 300 million in share buybacks, reflecting its commitment to shareholder interests [5] - Management's proactive attitude and robust measures are expected to instill confidence in investors, with a focus on continuous R&D innovation and market expansion [5] - The company aims to achieve steady growth in performance and is committed to becoming a world-class biopharmaceutical enterprise [5]
智飞生物20250509
2025-05-12 01:48
Summary of Zhifei Biological Conference Call Company Overview - **Company**: Zhifei Biological Products Co., Ltd. - **Industry**: Biopharmaceuticals, specifically focusing on vaccines and metabolic disease treatments Key Points and Arguments Financial Performance - **Revenue Decline**: Starting from Q2 2024, the company experienced a significant decline in performance, particularly in HPV vaccine sales, attributed to economic cycles, reduced consumer willingness, and vaccine hesitancy [2][3][4] - **Losses**: The company reported three consecutive quarters of losses as of Q1 2025, with accounts receivable dropping from 30 billion to 14 billion, but with extended turnover days [3][10] - **Cash Dividends**: In 2024, the company distributed a total cash dividend of 2.394 billion, alongside a stock buyback exceeding 300 million [6][11] Strategic Measures - **Response to Challenges**: The company is actively seeking new growth points and has adjusted procurement plans with partners like GSK and Merck to align with market demand [2][4] - **Inventory Management**: Focus on reducing inventory levels, particularly for HPV and shingles vaccines, which are significant contributors to the current stock levels [8][9] - **Sales Promotion**: Enhanced marketing policies and public awareness campaigns to increase vaccination rates [4][9] Research and Development - **R&D Progress**: The company has 34 self-developed projects, with 19 in clinical trials or registration stages, including advancements in pneumonia, meningitis, and adult vaccines [5][15] - **Expansion into Metabolic Diseases**: Acquisition of a controlling stake in Cheng'an Biological, gaining access to GLP-1 receptor agonists, thus expanding into the metabolic disease sector [5][15] Corporate Governance and Social Responsibility - **Sustainability Report**: The company released its first sustainability report, emphasizing R&D, governance, quality management, and community engagement [12][13] - **Charitable Contributions**: Participation in 12 charitable projects with total donations exceeding 400 million, showcasing commitment to social responsibility [7][13] Future Outlook - **Operational Focus for 2025**: Key initiatives include inventory reduction, debt recovery, and risk management, with a strong emphasis on HPV and shingles vaccine sales [8][9] - **Market Expansion**: Plans to enhance international market presence and expedite the registration of new vaccine products [9][10] Market Challenges - **Industry Downturn**: The company is navigating a challenging environment characterized by high investment requirements and long product cycles, necessitating a focus on maintaining operational stability [11][15] Conclusion - **Long-term Vision**: Zhifei Biological aims to solidify its position as a leading biopharmaceutical company through innovation, strategic partnerships, and a commitment to sustainable practices, while addressing immediate operational challenges [6][15]
智飞生物(300122) - 投资者关系活动记录表(2025年5月9日)
2025-05-09 11:54
Financial Performance - In 2024, the company's operating revenue was 26.07 billion, a decrease of 50.74% year-on-year [15] - Net profit for 2024 was 2.018 billion, down 74.99% compared to the previous year [15] - The decline in performance is attributed to economic cycles, structural changes, industry adjustments, and increased vaccine hesitancy [15] Challenges and Responses - The company has faced significant operational difficulties since Q2 2023, with a notable drop in sales of core products like HPV vaccines [2][3] - Measures taken include enhancing communication with partners, adjusting promotional policies, and increasing public awareness of disease prevention [3] - As of Q1 2024, accounts receivable decreased to 14.6 billion, with ongoing efforts to manage aging receivables [4] Inventory and Debt Management - The increase in inventory is primarily due to reduced sales of key products, with a focus on managing raw materials and finished goods [6][7] - The company aims to reduce inventory risks through collaboration with partners and improving market promotion [7] - Short-term borrowings have increased to support normal operations, with a focus on debt structure optimization [7] Market and Value Management - The company has implemented a market value management system, with a planned cash dividend of 2.394 billion for 2024, including a mid-year dividend of 479 million [8] - Since its listing in 2010, the company has distributed over 7.318 billion in dividends and conducted multiple share buybacks [8] ESG and Sustainability Efforts - The company released its first sustainability report, highlighting its commitment to environmental, social, and governance (ESG) practices [10] - It has engaged in 12 public welfare projects, donating over 10.96 million in the past year [10] - The company received an AA rating in MSCI ESG ratings, showcasing its leadership in governance and social impact [11] Future Outlook and Strategic Initiatives - The company aims to transition into the therapeutic biopharmaceutical field, with a focus on metabolic diseases [13] - It has a robust pipeline of products, including several in clinical trials, to support future growth [13][15] - The vision is to become a world-class biopharmaceutical enterprise, leveraging innovation and market expansion [14]