Workflow
ZHIFEI-BIOL(300122)
icon
Search documents
智飞生物(300122) - 关于三价流感病毒裂解疫苗(ZFA02佐剂)获得临床试验批准通知书的公告
2025-04-01 11:24
证券代码:300122 证券简称:智飞生物 公告编号:2025-11 重庆智飞生物制品股份有限公司 关于三价流感病毒裂解疫苗(ZFA02 佐剂) 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 公司安徽智飞龙科马生物制药有限公司(以下简称"智飞龙科马")研发的三价流 感病毒裂解疫苗(ZFA02 佐剂)(以下简称"佐剂三价流感疫苗")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:2025LP00953),同意开展 预防疫苗相关型别流感病毒引起的流行性感冒的临床试验。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 流感是由流行性感冒病毒引起的可造成大规模流行的急性呼吸道传染病。流 感的传染性强,可引发肺炎、支气管炎、心肌炎等并发症,也可加重老年人、体 弱者等高危人群的基础疾病。接种流感疫苗是预防流感疾病及流感大爆发最经济、 有效的措施。本次临床试验申请获得批准的佐剂三价流感疫苗,含公司自主研制 的 ZFA02 佐剂, ...
智飞生物_九价人乳头瘤病毒(HPV9)疫苗推广,在江苏启东优惠 33%
2025-04-01 04:17
Summary of Chongqing Zhifei Biological Products Conference Call Company Overview - **Company Name**: Chongqing Zhifei Biological Products - **Industry**: Biotechnology - **Main Products**: Vaccines including anti-meningitis, anti-pneumonia, anti-rabies, and influenza vaccines - **Distribution Network**: Covers 31 provinces and over 300 cities in China, with more than 1,500 sales personnel as of 2018 [10][25] Key Points from the Conference Call HPV9 Promotion - **Promotion Details**: Jiangsu Qidong announced a "Buy two get one free" program for HPV9 targeting females aged 9-14, ending on November 30 [2] - **Demand Analysis**: Demand for HPV9 is weak at the original price level, indicating potential issues with sales [2][3] - **Financial Impact**: The promotion is expected to have a neutral financial impact as it is limited to a small region and specific age group, but it may help improve cash balance and inventory levels [3] Financial Metrics - **Market Capitalization**: Rmb59.8 billion (approximately US$8.23 billion) [5] - **12-Month Price Target**: Rmb31.00 with a current rating of Neutral [4][25] - **52-Week Stock Price Range**: Rmb46.64 to Rmb20.65 [5] - **Earnings Per Share (EPS) Estimates**: - 2024E: Rmb1.38 (UBS), Rmb1.68 (Consensus) - 2025E: Rmb1.72 (UBS), Rmb1.41 (Consensus) - 2026E: Rmb1.47 (UBS), Rmb1.67 (Consensus) [6] Revenue and Profitability Forecasts - **Revenue Projections**: - 2024E: Rmb32.015 billion - 2025E: Rmb28.156 billion - 2026E: Rmb22.275 billion [8] - **Net Earnings**: - 2024E: Rmb3.312 billion - 2025E: Rmb4.125 billion - 2026E: Rmb3.513 billion [8] - **Profitability Metrics**: - EBIT margin expected to decline from 12.2% in 2024E to 10.0% in 2028E [8] Risks and Opportunities - **Downside Risks**: Increased competition in the HPV vaccine market and slow sales ramp-up of GSK's Shingrix in China [11] - **Upside Risks**: Potential for an earlier end to inventory destocking and improved consumer demand for discretionary vaccines [11] Analyst Ratings and Market Expectations - **Forecast Stock Return**: Expected stock return of 25.6%, with a price appreciation forecast of 24.0% and a dividend yield of 1.6% [9] - **Current Rating**: Neutral, indicating no significant expected changes in stock performance [4][25] Additional Insights - **Channel Stocking Levels**: High channel stocking levels suggest that the company is attempting to sell down inventory, potentially at a loss [3] - **Future Order Intentions**: Continued sales below the purchase price from Merck could impact future order commitments for HPV9 [3] This summary encapsulates the key insights and financial metrics discussed during the conference call regarding Chongqing Zhifei Biological Products, highlighting both the challenges and opportunities within the biotechnology sector.
智飞生物(300122) - 关于公司吸附破伤风疫苗临床试验申请获得受理的公告
2025-03-28 10:34
证券代码:300122 证券简称:智飞生物 公告编号:2025-10 重庆智飞生物制品股份有限公司 关于吸附破伤风疫苗临床试验申请获得受理的公告 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")研发的吸附破 伤风疫苗获得国家药品监督管理局药物临床试验申请受理通知书(受理号: CXSL2500250)。自受理之日起 60 日内,未收到药审中心否定或质疑意见的, 智飞绿竹可以按照提交的方案开展临床试验。 一、研发项目简介 破伤风是由破伤风梭状芽孢杆菌通过皮肤或黏膜的破口侵入人体,引起的以 全身骨骼肌持续强直性收缩和阵发性痉挛为特征的急性、特异性、中毒性疾病。 重症患者可发生喉痉挛、窒息、肺部感染和器官衰竭,在无医疗干预的情况下, 病死率接近 100%,即使经过积极的综合治疗,全球范围病死率仍为 30%-50%。 破伤风由产毒的破伤风梭状芽孢杆菌引起,多散发于我国偏远及医疗卫生条件欠 发达地区和外伤处置不妥当的人群中,是一种极为严重的潜在致命 ...
智飞生物将增资取得宸安生物控股权 标的公司重磅产品即将商业化
证券时报网· 2025-03-28 09:55
Core Viewpoint - Zhifei Biological is acquiring a controlling stake in Chongqing Chanan Biopharmaceutical Co., Ltd. through a capital increase, marking its first capital operation to gain control over another company since its listing in 2025 [1][2]. Group 1: Acquisition Details - Zhifei Biological plans to invest nearly 600 million yuan to gain control of Chanan Biopharmaceutical, which focuses on therapeutic biopharmaceuticals [2]. - Chanan Biopharmaceutical has invested nearly 700 million yuan in its research pipeline over the past decade, with key products nearing commercialization [2][4]. - The agreement emphasizes supporting Chanan's therapeutic biopharmaceutical business for high-quality development [2][3]. Group 2: Product Pipeline and Market Potential - Chanan Biopharmaceutical's core products, including semaglutide injection for diabetes and weight loss, are in advanced clinical stages [3][4]. - The global market for GLP-1 drugs is projected to exceed 100 billion USD by 2030, with semaglutide sales in China expected to grow from 2.5 billion RMB in 2022 to 43.9 billion RMB by 2032, reflecting a compound annual growth rate of 33.0% [4][5]. - The company has a robust pipeline with over ten projects in development, including semaglutide and insulin analogs, positioning it among the industry leaders [5][6]. Group 3: Strategic Implications - This acquisition aligns with Zhifei Biological's strategy of integrating prevention and treatment, enhancing its market competitiveness and risk resilience [7][8]. - The transaction is seen as a significant step in Zhifei's long-term strategy to expand into therapeutic drug development, thereby diversifying its business beyond vaccines [8][9]. - The collaboration is expected to leverage Zhifei's extensive sales network to enhance the commercialization prospects of Chanan's products [8].
智飞生物(300122) - 投资者关系活动记录表(2025年3月27日)
2025-03-27 10:39
Investment and Business Strategy - The company announced a cash increase of RMB 593 million to gain a 51% stake in Chuanan Biotech, focusing on diabetes treatment with multiple projects in development [2][3] - Chuanan Biotech's pipeline includes drugs in various stages, such as liraglutide injection in the listing application phase and two candidates in Phase III trials [2][3] - This acquisition allows the company to expand its business from vaccines to metabolic diseases, aiming to establish a therapeutic biopharmaceutical sector [3] Collaboration and Market Development - The company has been collaborating with GSK since October 2023 to promote the recombinant shingles vaccine, with ongoing sales and market access efforts [4][5] - The partnership has been extended to enhance risk management and mutual trust, allowing for phased procurement based on market demand [4][5] Research and Development Focus - The company targets high-incidence diseases such as tumors, autoimmune diseases, and metabolic disorders, leveraging its investment platform for innovation [5][8] - Chuanan Biotech's products, including semaglutide injections, have completed critical clinical trials, contributing to the company's therapeutic drug portfolio [5][8] Internationalization Strategy - The company is actively pursuing internationalization, with a focus on global partnerships and product exports [6][7] - A new tuberculosis diagnostic tool has been approved in Indonesia, marking a significant step in the company's international efforts [7] R&D Team and Investment - The company has over 1,000 R&D personnel, with more than 50% holding master's or doctoral degrees, and has established a postdoctoral research station [8] - From 2019 to 2024, the company plans to invest over RMB 4 billion in R&D to enhance innovation and industry positioning [8] Product Pipeline and Progress - The company has developed multiple research bases and innovation centers, with 8 products currently on the market and 33 projects in development [9][10] - Recent approvals include a quadrivalent influenza vaccine, with several other products in various clinical trial phases [10] Commitment to Stakeholders - The company emphasizes social benefits over corporate profits, focusing on high-quality development and investor returns through cash dividends and share buybacks [11] - Since its listing, the company has distributed a total of RMB 73.18 million in cash dividends, reflecting its commitment to shareholder value [11]
智飞生物(300122):增资宸安生物,治疗性生物制品打造新增量
中信建投· 2025-03-26 06:00
Investment Rating - The report maintains a "Buy" rating for the company, indicating a potential relative price increase of over 15% in the next six months [4][16]. Core Views - On March 21, the company invested CNY 593 million in Chen'an Bio, acquiring a 51% stake, which allows the company to control Chen'an Bio. This investment is seen as a strategic move to expand into the therapeutic biopharmaceutical sector, particularly in metabolic diseases [2][3][8]. - Chen'an Bio has developed multiple products targeting diabetes and obesity, with several pipelines in late clinical stages or awaiting market approval. The investment is expected to create a new revenue stream for the company as these products move towards commercialization [3][8][10]. Financial Overview - The company forecasts revenues of CNY 274.39 billion, CNY 300.20 billion, and CNY 324.13 billion for 2024, 2025, and 2026, respectively. The net profit is projected to be CNY 23.49 billion in 2024, with a significant decline of 70.9% year-on-year, followed by growth in the subsequent years [3][16]. - Key financial metrics for the company include: - Revenue (CNY million): 38,264.01 in 2022, projected 52,917.77 in 2023, and 27,438.55 in 2024 - Net Profit (CNY million): 7,539.00 in 2022, projected 8,069.87 in 2023, and 2,348.74 in 2024 - EPS (CNY): 3.15 in 2022, projected 3.37 in 2023, and 0.98 in 2024 [3][16]. Strategic Developments - The investment in Chen'an Bio is part of the company's strategy to diversify its business from vaccines to therapeutic biopharmaceuticals, which is expected to be a significant growth driver in the future [3][10][15]. - The report highlights that Chen'an Bio's pipelines, including GLP-1 analogs and insulin products, are positioned well in the market, with some products nearing commercialization [8][9][10].
智飞生物(300122) - 关于自主产品四价流感病毒裂解疫苗获得药品注册证书的公告
2025-03-21 11:14
证券代码:300122 证券简称:智飞生物 公告编号:2025-09 5、审批结论:根据《中华人民共和国药品管理法》《中华人民共和国疫苗 管理法》及有关规定,经审查,本品符合药品注册的有关要求,批准注册,发给 药品注册证书。 重庆智飞生物制品股份有限公司 关于公司自主产品四价流感病毒裂解疫苗获得药品注册证书的公告 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,由公司全 资子公司安徽智飞生物制药有限公司研发的四价流感病毒裂解疫苗获得国家药 品监督管理局出具的《药品注册证书》,现将相关情况公告如下: 一、药品基本情况 1、药品通用名称:四价流感病毒裂解疫苗 4、剂型:注射剂 二、获批注册的意义 2、药品批准文号:2025S00758 3、注册分类:预防用生物制品 2、公司将严格按照药品监管的现行要求,在本产品获得生物制品批签发证 明后开展相应商业化工作。 敬请广大投资者谨慎决策,注意防范投资风险。 特此公告 重庆智飞生物制品股份有限公司董事会 流感是由流行性感冒病毒引起的可造成大规模流行的急性呼吸道传染 ...
智飞生物(300122) - 关于对重庆宸安生物制药有限公司现金增资暨关联交易的公告
2025-03-21 10:16
证券代码:300122 证券简称:智飞生物 公告编号:2025-08 重庆智飞生物制品股份有限公司 关于对重庆宸安生物制药有限公司现金增资暨关联交易的公告 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。 特别提示: 重庆智飞生物制品股份有限公司(以下简称"公司""上市公司"或"智飞 生物")以现金 59,326.5306 万元对重庆宸安生物制药有限公司(以下简称"标的 公司"或"宸安生物")实施增资,按照 1.2584 元/注册资本的价格认购,取得标 的公司 51%的股权,实现对标的公司的控股。相关各方已于 2025 年 3 月 21 日 签署了《关于重庆宸安生物制药有限公司之增资扩股协议》(以下简称"《增资 扩股协议》")。 本次增资以具有证券期货业务资格的资产评估机构出具的《评估报告》 中的评估结果作为定价依据,协商确定本次增资前宸安生物 100%股权价值为 57,000.00 万元,相应确定本次现金增资取得 51%股权的总增资金额为人民币 59,326.5306 万元,其中 47,142.8571 万元计入宸安生物注册资本,12,183.6735 万 元 ...
智飞生物(300122) - 第六届董事会第四次会议决议公告
2025-03-21 10:16
证券代码:300122 证券简称:智飞生物 公告编号:2025-06 重庆智飞生物制品股份有限公司 第六届董事会第四次会议决议公告 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。 2、本次会议于 2025 年 3 月 21 日 10:00 在公司会议室以现场结合通讯表决 方式召开。 3、本次会议应出席并参加表决的董事 9 人,实际出席并参加表决的董事 9 人。 4、本次会议由公司董事长蒋仁生先生主持。 5、本次会议的召集、召开和表决程序符合有关法律、行政法规、部门规章、 规范性文件及公司章程的规定。 二、董事会会议审议情况 经过各位董事认真审议,本次会议形成如下决议: 1、审议通过了《关于签署<关于重庆宸安生物制药有限公司之增资扩股协议> 暨关联交易的议案》 一、董事会会议召开情况 1、本次董事会于 2025 年 3 月 19 日以专人送达的方式向董事发出通知。 生物医药产业是关系国计民生的战略性新兴产业,是满足人民健康生活需求、 保障民族健康安全、构建公共卫生体系的重要支撑。公司积极响应"十四五"生 物医药产业发展规划,以"防未病治已病,守护人类健康"为使命 ...
智飞生物(300122) - 第六届监事会第三次会议决议公告
2025-03-21 10:16
证券代码:300122 证券简称:智飞生物 公告编号:2025-07 重庆智飞生物制品股份有限公司 5、本次会议的召集、召开和表决程序符合有关法律、行政法规、部门规章、 规范性文件和公司章程的规定。 1、本次监事会于 2025 年 3 月 19 日以专人送达的方式向监事发出通知。 2、本次会议于 2025 年 3 月 21 日 11:00 在公司会议室以现场结合通讯表决 方式召开。 第六届监事会第三次会议决议公告 本公司及监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。 一、监事会会议召开情况 3、本次会议应出席并参加表决的监事 3 人,实际出席并参加表决的监事 3 人。 4、本次会议由公司监事会主席荀婕女士主持。 具体内容详见同日发布于中国证监会指定信息披露网站巨潮资讯网的《关于 对重庆宸安生物制药有限公司现金增资暨关联交易的公告》(2025-08)。 表决结果:赞成 3 票,反对 0 票,弃权 0 票,本议案获得通过。 二、监事会会议审议情况 经过认真审议,本次会议形成了如下决议: 1、审议通过了《关于签署<关于重庆宸安生物制药有限公司之增资扩股协议> 暨关联交易的 ...