ZHIFEI-BIOL(300122)

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智飞生物:关于26价肺炎球菌结合疫苗进入Ⅰ/Ⅱ期临床试验的公告
2024-08-20 10:28
一、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、肺炎 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。 肺炎链球菌有 90 多种血清型,但造成侵袭性感染的血清型相对集中在部分 型别。智飞绿竹自主研发的 26 价肺炎结合疫苗为预防用生物制品,涵盖了目前 最常见的血清型,覆盖更广泛。26 价肺炎结合疫苗拟使用对象为 2 月龄及以上 人群,用于预防肺炎链球菌相关血清型引起的侵袭性疾病。 二、同类产品市场情况 证券代码:300122 证券简称:智飞生物 公告编号:2024-38 重庆智飞生物制品股份有限公司 关于 26 价肺炎球菌结合疫苗进入Ⅰ/Ⅰ期临床试验的公告 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、 ...
智飞生物:关于公司撤回四价流感病毒裂解疫苗(西林瓶包装)注册申请的公告
2024-08-15 11:08
证券代码:300122 证券简称:智飞生物 公告编号:2024-37 一、药品基本情况 药品名称:四价流感病毒裂解疫苗(西林瓶包装) 注册分类:预防用生物制品:3.3 类 重庆智飞生物制品股份有限公司 关于公司撤回四价流感病毒裂解疫苗 (西林瓶包装)注册申请的公告 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")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")于近日收到国家药品监督 管理局核准签发的《药品注册申请终止通知书》,同意智飞龙科马撤回四价流感 病毒裂解疫苗(西林瓶包装)的注册申请。现将相关情况公告如下: 二、药品的相关情况 公司自主研发的四价流感病毒裂解疫苗用于预防疫苗相关型别的流感病毒 引起的流行性感冒,该产品已于 2022 年 6 月获得Ⅲ期临床试验总结报告,并于 2023 年 7 月获得国家药品监督管理局出具的申请生产注册《受理通知书》[受理 号:CXSS2300059(预灌封包装)、CXSS2300060(西林瓶包装)]。 基于流感疫苗产品线创新性差异化的考虑,为进一步优化公 ...
智飞生物:葛兰素史克RSV疫苗启动中国III期临床试验
Goldman Sachs· 2024-08-15 02:28
Investment Rating - The investment rating for Zhifei Biological (300122.SZ) is Neutral [2][4][16]. Core Views - Zhifei Biological is a major player in the Chinese vaccine market, with core products including the quadrivalent/nine-valent HPV vaccine (in collaboration with Merck), shingles vaccine (in collaboration with GSK), and self-developed vaccines and tuberculosis products. The company is expected to launch several products in the next three years, which should support revenue growth. However, the quadrivalent/nine-valent HPV vaccine may face a decline starting in 2025 due to the latest agreement with Merck [2][4]. - The report highlights key events to watch: the launch of the human diploid cell rabies vaccine, the 15-valent pneumococcal conjugate vaccine, and the quadrivalent influenza vaccine, as well as new product licensing from multinational companies [2][4]. Summary by Sections Investment Rating - The report assigns a Neutral rating to Zhifei Biological, indicating that the current valuation is reasonable compared to the historical average pre-COVID-19 [2][4]. Financial Projections - The 12-month price target for Zhifei Biological is set at RMB 52, based on a two-stage discounted cash flow valuation method, with a discount rate of 9% and a perpetual growth rate of 2% [3][4]. - Revenue projections for the upcoming years are as follows: RMB 52.92 billion for 2023, RMB 55.59 billion for 2024, RMB 51.37 billion for 2025, and RMB 50.44 billion for 2026 [4]. Key Products and Developments - The report notes that the RSV vaccine developed by GSK has entered Phase III clinical trials in China, with an expected completion date for the primary endpoint follow-up in March 2025. If successful, it may receive approval from the National Medical Products Administration in the first half of 2026 [1]. - The quadrivalent/nine-valent HPV vaccine is expected to face a decline starting in 2025, which is a significant concern for the company's revenue [2][4].
智飞生物:2023年年度权益分派实施公告
2024-08-01 11:28
证券代码:300122 证券简称:智飞生物 公告编号:2024-36 重庆智飞生物制品股份有限公司 2023 年年度权益分派实施公告 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")2023年年度权益分派 方案已获2024年6月18日召开的2023年年度股东大会审议通过,现将权益分派事 宜公告如下: 一、股东大会审议通过利润分配方案情况 1、本公司 2023 年年度股东大会审议通过的 2023 年年度权益分派方案为: 公司以 2,393,789,747 股为基数,向全体股东每 10 股派发现金红利 8.00 元(含 税),送红股 0 股(含税),以资本公积金向全体股东每 10 股转增 0 股。如在 2023 年年度利润分配相关公告披露后至实施权益分派的股权登记日前,公司总 股本发生变动的,将以实施分配方案时股权登记日的总股本为基数,按照现金分 红总额、送红股总额、转增股本总额固定不变的原则实施; 1 2、扣税说明:扣税后,通过深股通持有股份的香港市场投资者、QFII、RQFII 以及持有首发前限售股的个人和证券投 ...
智飞生物:关于取得发明专利证书的公告
2024-07-30 10:52
证券代码:300122 证券简称:智飞生物 公告编号:2024-35 重庆智飞生物制品股份有限公司 关于取得发明专利证书的公告 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。 1 | 发明专利名称 | 专利号 | 专利证书号 | 专利类型 | 专利申请日 | 授权公告日 | 专利权人 | | --- | --- | --- | --- | --- | --- | --- | | 一种低聚合破伤 风类毒素制备方 | ZL202210464623.9 | 第 7245617 号 | 发明专利 | 2022 年 04 月 | 2024 年 07 月 | 智飞生物 智飞绿竹 | | 法 | | | | 29 日 | 30 日 | 智飞龙科马 | 上述发明专利为公司自主研发,将在公司相关在研产品上应用。该专利证书 的取得不会对公司近期生产经营产生重大影响,但有利于进一步完善公司知识产 权保护体系,充分发挥自主知识产权优势,促进技术创新,提升公司的核心竞争 力。 特此公告 重庆智飞生物制品股份有限公司董事会 2024 年 7 月 30 日 重庆智飞生物制品股份有限公司(以 ...
智飞生物:关于四价重组诺如病毒疫苗进入Ⅲ期临床试验的公告
2024-07-29 10:41
证券代码:300122 证券简称:智飞生物 公告编号:2024-33 重庆智飞生物制品股份有限公司 关于四价重组诺如病毒疫苗进入Ⅲ期临床试验的公告 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研发的四价重组诺如病毒疫苗(毕赤酵 母)(以下简称"四价重组诺如疫苗")在广西、湖南、四川开展Ⅲ期临床试验。 一、项目简介 三、Ⅲ期临床试验相关情况 四价重组诺如疫苗的Ⅲ期临床试验在广西、湖南和四川启动,采用多中心、 随机、盲法、安慰剂对照设计,以评价该疫苗接种于 6 周龄及以上人群中的有效 性和安全性。 四、风险提示 1 1、药品研制是非常复杂严谨的科学活动,具有投入大,周期长,风险高的 特点,产品的研发和行政审批主要有以下几个阶段:临床前研究;申请临床试验; 进行临床试验;申请生产文号;疫苗批签发后上市销售。 2、公司四价重组诺如疫苗进入Ⅲ期临床试验阶段不会对公司近期业绩产生 重大影响。若未来该产品研发顺利,将进一步丰富公司肠道疫苗矩阵产品布局, 满足更广泛的民 ...
智飞生物:关于四价流感病毒裂解疫苗(ZFA02佐剂)临床试验申请获得受理的公告
2024-07-29 10:39
重庆智飞生物制品股份有限公司 关于四价流感病毒裂解疫苗(ZFA02 佐剂) 证券代码:300122 证券简称:智飞生物 公告编号:2024-34 新技术、增强核心攻关的成果。若本项目进展顺利,将进一步丰富公司病毒类疫 苗品种,充实公司成人疫苗矩阵项目,完善公司产品布局,强化公司的市场竞争 优势。 三、风险提示 1、药品研制是非常复杂严谨的科学活动,具有投入大,周期长,风险高的 特点,产品的研发和行政审批主要有以下几个阶段:临床前研究;申请临床试验; 进行临床试验;申请生产文号;上市销售。 2、公司佐剂四价流感疫苗临床试验申请获得受理对公司近期业绩不会产生 重大影响,若未来产品研发顺利,将丰富公司产品结构,强化公司的市场地位, 增强公司盈利能力。 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")研发的四价流 感病毒裂解疫苗(ZFA02 佐剂)(以下简称"佐剂四价流感疫苗")获得国家药品 监督管理局药物临床试 ...
智飞生物:关于公司控股股东部分股份质押的公告
2024-07-26 10:37
证券代码:300122 证券简称:智飞生物 公告编号:2024-32 重庆智飞生物制品股份有限公司 一、控股股东股份质押的基本情况 1、本次股份质押基本情况 | 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 用途 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 东及其 | (股) | (%) | (%) | 售股 | 押 | | | | | | 一致行 动人 | | | | | | | | | | | | | | | | | | 重庆农 | | | | | | | | | | | 村商业 | 股权 | | 蒋仁生 | 是 | 20,500,000 | 1.77 | 0.86 | 是 | 否 | 2024-07-19 2030-11-07 | 银行股 | 类投 | | | | | | | | | | 份有限 | 资 | | | | | | | | | | 公司 | ...
三问三答,探究智飞生物经营拐点
海通国际· 2024-07-11 11:00
Investment Rating - The report assigns an "Outperform" rating to the company, with a target price of 46.20 yuan, reflecting a 12x P/E ratio for 2024 [7]. Core Insights - The company is experiencing a seasonal increase in accounts receivable and inventory, with accounts receivable rising by 11% to 30.03 billion yuan in Q1 2024, while inventory increased by 40% to 12.61 billion yuan [3][12]. - The company has a strong grassroots sales channel, with 3,990 sales personnel as of the end of 2023, significantly surpassing industry peers [4][19]. - The HPV vaccine is entering a mature phase, with a current vaccination rate of 21% among eligible women, indicating potential for growth [4][21]. - The company has secured exclusive distribution rights for GSK's shingles vaccine, with minimum procurement amounts projected at 3.44 billion yuan for 2024 [4][18]. - The company is expanding its product pipeline, including vaccines for tuberculosis, pneumonia, influenza, and rabies, and plans to acquire Chen'an Biotech to enter the diabetes and obesity treatment market [4][31]. Summary by Sections Accounts Receivable and Inventory Increase in Q1 2024 - Accounts receivable increased by 11% to 30.03 billion yuan, while inventory rose by 40% to 12.61 billion yuan [12][16]. - The increase in accounts receivable is attributed to seasonal factors, with a notable decrease in turnover days compared to peers [3][12]. Company's Operational Advantages and "Second Curve" - The company has a robust grassroots channel and a dual-driven model of technology and market, with R&D spending of 1.35 billion yuan in 2023 [4][19]. - The company is entering a "second curve" by diversifying its product offerings and expanding into new therapeutic areas [20][28]. - The shingles vaccine market has a potential capacity of 164.8 billion to 1,648.5 billion yuan, depending on penetration rates [26][27]. Shareholder Return Attributes - The company plans to distribute a total dividend of at least 10 yuan per 10 shares, corresponding to a dividend yield of 3.5% [5][32]. - A share buyback of 300 million yuan has been completed, reflecting the company's commitment to returning value to shareholders [5][32]. Profit Forecast and Valuation - The company is projected to achieve net profits of 9.22 billion, 11.32 billion, and 12.71 billion yuan for 2024-2026, with respective growth rates of 14%, 23%, and 12% [7][34]. - The revenue forecast for 2024 is 58.85 billion yuan, with a year-on-year growth of 11.2% [35].
公司研究报告:三问三答,探究智飞生物经营拐点
海通国际· 2024-07-11 08:02
Investment Rating - The report assigns an "OUTPERFORM" rating to the company with a target price of Rmb 46.2 [1]. Core Insights - The report explores the operational turning point of the company, highlighting its strong grassroots channels, significant R&D investments, and potential growth areas in the HPV and shingles vaccine markets [2][4][8]. Summary by Sections 1. Accounts Receivable and Inventory Increase in Q1 2024 - The company's accounts receivable increased by 11% to Rmb 30.03 billion, while inventory rose by 40% to Rmb 12.61 billion, attributed to seasonal factors [3][14]. - The accounts receivable turnover days are significantly lower than peers at 162 days, indicating a low risk of uncollectible accounts [3][16]. 2. Operational Advantages and "Second Curve" - The company boasts a robust grassroots channel with 3,990 sales personnel, far exceeding industry peers, and has secured agency rights for major products from GSK and Merck [4][21]. - Revenue in Q1 2024 grew by 2% year-on-year, indicating the HPV vaccine may be entering a mature phase, with a current vaccination rate of 21% among eligible women [4][24]. - The company is set to officially launch GSK's shingles vaccine in 2024, with projected minimum procurement amounts of Rmb 34.4 billion, Rmb 68.8 billion, and Rmb 103.2 billion for 2024-2026 [4][20]. - The company has a rich pipeline of self-developed products in various stages, including tuberculosis and influenza vaccines, and plans to acquire a company to expand into diabetes and weight loss medications [4][31][34]. 3. Shareholder Return Attributes - The company plans to distribute a total dividend of at least Rmb 10 per 10 shares for 2023 and 2024, corresponding to a dividend yield of 3.5% [5][35]. - A share buyback of Rmb 300 million has been completed, and an employee stock ownership plan has been implemented, with 2,910,000 shares purchased [5][36]. 4. Earnings Forecast and Valuation - The company’s projected net profits for 2024-2026 are Rmb 9.22 billion, Rmb 11.32 billion, and Rmb 12.71 billion, reflecting year-on-year growth rates of 14%, 23%, and 12% respectively [8][37]. - The report assigns a P/E ratio of 12x for 2024, leading to a target price of Rmb 46.20, with a market capitalization estimate of Rmb 922 billion to Rmb 1,106 billion [8][39].