自研加速，智飞生物（300122）于4月8日晚间连发三条公告，该上市公司旗下四价流脑结合疫苗、治疗 用卡介苗及双价痢疾结合疫苗已进入关键研发阶段，其技术突破与市场布局引发行业高度关注。 资料显示，引起细菌性痢疾的志贺菌主要包括4种菌群：痢疾志贺菌、福氏志贺菌、鲍氏志贺菌和宋内 氏志贺菌，全球以福氏、宋内氏志贺菌感染为主，占总发病数的90%以上。2024年，世界卫生组织将志 贺菌列入细菌重点病原体清单(WHO BPPL)，凸显志贺菌在疾病负担方面的全球影响力。 公告指出，由智飞生物研发的产品主要针对福氏、宋内氏志贺菌2种菌群；截至目前，全球暂无同类疫 苗获批上市。根据智飞生物收到孟加拉国药品管理总局签发的III期临床试验批件，双价痢疾结合疫苗拟 在孟加拉国开展的III期临床试验，将采用随机、盲法、安慰剂对照评价该疫苗针对6月龄至5周岁婴幼儿 的有效性、免疫原性和安全性。此外，智飞生物该疫苗产品的国内III期临床试验已于2021年12月开展， 若在孟加拉国开展的III期临床试验进展顺利，将进一步充实智飞生物申请双价痢疾疫苗生产注册的临床 数据，加速推动项目进展。 再看第三则临床消息，来自于智飞生物全资子公司安徽智 ...

4月8日晚间，智飞生物（300122）连续发布三则公告，宣布其全资子公司研发的四价流脑结合疫苗完成 III期临床试验总结报告，治疗用卡介苗进入III期临床试验阶段，以及双价痢疾结合疫苗将于孟加拉国启 动III期受试者入组工作。三项进展标志着公司在脑膜炎、膀胱癌及细菌性痢疾领域疫苗研发的全面突 破。 四价流脑结合疫苗接近上市阶段，将强化脑膜炎疫苗市场布局 据公告显示，智飞生物全资子公司北京智飞绿竹生物制药有限公司研发的ACYW135群脑膜炎球菌多糖 结合疫苗(简称"四价流脑结合疫苗")已获得三期临床试验总结报告。该疫苗主要用于预防由A、C、Y、 W135群脑膜炎球菌引起的流行性脑脊髓膜炎，是一种起病急、进展快、传染性强、病死率高且致残率 高的急性化脓性脑膜炎。 临床试验结果表明，这款疫苗具有良好的免疫原性及安全性，全面达到临床试验预设目标，在免疫原性 方面非劣效于对照疫苗，且基本符合《脑膜炎球菌疫苗临床试验技术指导原则》对免疫原性与安全性评 价的设计要求。 智飞生物的另一全资子公司北京智飞绿竹生物制药有限公司研发的福氏宋内氏痢疾双价结合疫苗(简 称"双价痢疾结合疫苗")也传来好消息。该疫苗已根据孟加拉国药品管理 ...

证券代码：300122 证券简称：智飞生物 公告编号：2025-13 重庆智飞生物制品股份有限公司 关于双价痢疾结合疫苗将于孟加拉国启动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"）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"）研发的福氏宋内氏痢 疾双价结合疫苗（以下简称"双价痢疾结合疫苗"）根据孟加拉国药品管理总局签 发的Ⅲ期临床试验批件，已经完成于孟加拉国开展Ⅲ期临床试验的准备工作，即 将启动受试者入组。现将相关情况公告如下： 四、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，公司将根据当地法规及批件要求，有序开展和推进临床试验相关工作。 一、研发项目简介 双价痢疾结合疫苗用于预防福氏志贺菌、宋内氏志贺菌引起的急性肠道传染 病，即细菌性痢疾。细菌性痢疾是由志贺菌属引起的一种肠道传染病，又称志贺 菌病，以腹痛、腹泻、里急后重、脓血便等为主要临床症状，各年龄群均可发病， 常见于婴幼儿和老年人，多发于夏秋季节。该疾病被列为我国 ...

证券代码：300122 证券简称：智飞生物 公告编号：2025-12 重庆智飞生物制品股份有限公司 关于四价流脑结合疫苗获得Ⅲ期临床试验总结报告 的提示性公告 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。 二、同类产品的市场情况 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。 1 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"）获得了Ⅲ期临床试 验总结报告。根据《深圳证券交易所上市公司自律监管指引第 4 号——创业板行 业信息披露》规定，现将相关情况公告如下： 一、基本情况 疫苗名称：四价流脑结合疫苗 适应症：预防由 A、C、Y、W135 群脑膜炎球菌引起的流行性脑脊髓膜炎 临床试验批件号：2014L01922 临床试验分期：Ⅲ期临床试验 研究方法：随机、盲法、同类疫苗对照的临床试验 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 ...

证券代码：300122 证券简称：智飞生物 公告编号：2025-14 重庆智飞生物制品股份有限公司 关于治疗用卡介苗进入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（以下简称"智飞龙科马"）自主研发的治 疗用卡介苗进入Ⅲ期临床试验。现将相关情况公告如下： 三、Ⅲ期临床试验相关情况 1 治疗用卡介苗的Ⅲ期临床试验在湖南省完成首例受试者给药。该临床试验采 用多中心、随机、盲法对照设计，以评价该产品用于预防 18 周岁及以上人群非 肌层浸润性膀胱癌术后复发的有效性和安全性。 四、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； 开展临床试验；申请生产文号；上市销售。 2、公司治疗用卡介苗进入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，将进一步丰富公司产品布局，强化公司的市场竞 争地位，满足更广泛的民众健康需求。 ...

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， ...

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.

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 ...

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].

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]