Core Viewpoint - The approval of the clinical trial for the freeze-dried Hib vaccine marks a significant milestone in the company's product development strategy, enhancing its position in the domestic vaccine market and supporting sustainable growth in its vaccine business [1][2]. Group 1: Clinical Trial Approval - The company has received the clinical trial approval notice for the freeze-dried Hib vaccine from the National Medical Products Administration [1]. - The vaccine is classified as a Class 3.3 preventive biological product and is intended to prevent invasive infections caused by Haemophilus influenzae type b, including meningitis, pneumonia, and sepsis [1]. Group 2: Product Information - The Hib vaccine is developed using purified Hib capsular polysaccharide combined with tetanus toxoid protein, and it is expected to induce an immune response against Hib, providing protection to recipients [2]. - The company is also developing a combination vaccine based on the DTP (diphtheria, tetanus, and pertussis) framework, with the Hib vaccine as one of its components [2]. Group 3: Significance of Approval - The approval of the freeze-dried Hib vaccine is a strategic success for the company, enriching its product portfolio and representing a crucial step towards developing multi-component vaccines [2]. - This development is expected to strengthen the company's position in the domestic second-class vaccine sector and contribute to the sustainable development of its vaccine business [2].

华兰生物公告，控股子公司华兰疫苗申报的"冻干b型流感嗜血杆菌结合疫苗"临床试验申请获得国家药 品监督管理局批准。该疫苗用于预防由b型流感嗜血杆菌引起的侵袭性感染，包括脑膜炎、肺炎、败血 症等。疫苗公司将尽快开展相关临床试验工作。 ...

（记者 王瀚黎） 每经头条（nbdtoutiao）——美罢免劳工统计局长后，首个重要数据再遭质疑：样本缺失、数据缩水、 人员短缺，7月CPI还能信吗？ 每经AI快讯，华兰疫苗8月13日晚间发布公告称，华兰生物疫苗股份有限公司于近日收到国家药品监督 管理局核准签发的关于冻干b型流感嗜血杆菌结合疫苗的《药物临床试验批准通知书》。 ...

Core Viewpoint - Hualan Vaccine has received approval from the National Medical Products Administration for clinical trials of its Hib vaccine, which targets invasive infections caused by Haemophilus influenzae type b [1] Group 1: Company Developments - Hualan Vaccine announced on August 13 that it has obtained the clinical trial approval notice for its freeze-dried Hib vaccine [1] - The Hib vaccine is intended to prevent invasive infections such as meningitis, pneumonia, sepsis, cellulitis, arthritis, and epiglottitis caused by Haemophilus influenzae type b [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial of a lyophilized Haemophilus influenzae type b (Hib) conjugate vaccine, which is expected to induce an immune response against Hib and provide protection to recipients [1] Group 1: Vaccine Development - The Hib vaccine is composed of purified Hib polysaccharide combined with tetanus toxoid protein and is presented in a lyophilized form [1] - The company is also developing a combination vaccine based on the DTP (diphtheria, tetanus, and pertussis) components, with the Hib vaccine being one of the components [1] - Vaccine development is described as a complex and rigorous scientific activity, characterized by significant challenges and long timelines [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial of its Hib vaccine, which targets Haemophilus influenzae type b, a major pathogen causing acute lower respiratory infections in children [1] Group 1: Vaccine Development - The Hib vaccine is developed using purified Hib capsular polysaccharide combined with tetanus toxoid protein, and it is expected to induce an immune response against Hib, providing protection to the vaccinated individuals [1] - The company is also developing a combination vaccine based on the DTP (Diphtheria, Tetanus, Pertussis) framework, with the Hib vaccine as one of its components [1] Group 2: Clinical Trial and Regulatory Process - The Hib vaccine, as an unapproved single vaccine, requires the accumulation of clinical data to complete its registration application for market approval [1] - Successful registration of the Hib single vaccine will support future registration applications for the combination vaccine based on the DTP framework [1]

Core Viewpoint - Hualan Vaccine has received approval from the National Medical Products Administration for the clinical trial of its lyophilized Haemophilus influenzae type b (Hib) vaccine, marking a significant step in the company's product development strategy [2] Group 1: Company Developments - The approval of the Hib vaccine is an important milestone for Hualan Vaccine, as it will enrich the company's product line [2] - The Hib vaccine is classified as a Class 3.3 preventive biological product, aimed at preventing invasive infections caused by Haemophilus influenzae type b [2] - The company plans to support future registration applications for combination vaccines based on the Hib vaccine and DTP (Diphtheria, Tetanus, Pertussis) [2] Group 2: Industry Context - The development of vaccines typically involves long research and development cycles, and the company must conduct clinical trials in accordance with national regulations [2] - The company faces potential risks associated with the vaccine development process, including the possibility of research and development failures [2]

证券代码：301207 证券简称：华兰疫苗 公告编号：2025- 036 华兰生物疫苗股份有限公司 关于冻干b型流感嗜血杆菌结合疫苗获得 药物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的内容真实、准确和完整，没有虚假 记载、误导性陈述或重大遗漏。 产品名称：冻干b型流感嗜血杆菌结合疫苗 注册分类：预防用生物制品3.3类 申请事项：境内生产药品注册临床试验 申请人：华兰生物疫苗股份有限公司 通知书编号：2025LP02051 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，经审査，Hib疫苗符合药品注册的有关要求，同意开展预防由b型 流感嗜血杆菌引起的侵袭性感染（包括脑膜炎、肺炎、败血症、蜂窝织炎、 关节 炎、会厌炎等）的临床试验。 二、产品的相关情况 流感嗜血杆菌为革兰氏阴性杆菌，是儿童急性下呼吸道感染最主要的病原菌之 一，分为有荚膜型和无荚膜型，两者均可引发感染。无荚膜型菌株常可引发中耳炎 和鼻窦炎等疾病。主要由鼻咽部定植细菌在邻近部位传播所致；继发于血流侵袭的 感染通常由荚膜型菌株引起。有荚膜的菌株根据荚膜多糖的化学成分来进行分类， 迄今已发现 6 种 ...

Group 1 - The stock price of Hualan Biological Engineering closed at 18.40 yuan on August 8, down 0.04 yuan from the previous trading day, with a trading volume of 37,743 hands and a transaction amount of 0.70 billion yuan [1] - The stock experienced a fluctuation of 2.33% on that day, with a highest price of 18.64 yuan and a lowest price of 18.21 yuan [1] - Hualan Biological Engineering focuses on the research and production of biological products, primarily including influenza vaccines and other preventive biological products [1] Group 2 - The company has a total market capitalization of 110.59 billion yuan and a circulating market value of 26.06 billion yuan [1] - On August 8, the net outflow of main funds for Hualan Biological Engineering was 3.1622 million yuan, with a cumulative net outflow of 51.0651 million yuan over the past five days [1]

Group 1 - The core point of the news is that Hualan Vaccine's stock has been underperforming since its IPO, currently trading at 18.87 yuan, down 1.15% [1] - Hualan Vaccine was listed on the Shenzhen Stock Exchange's ChiNext on February 18, 2022, with an initial public offering (IPO) of 40.01 million shares at a price of 56.88 yuan per share [1] - The stock reached a peak of 79.78 yuan on its first trading day but has since experienced a decline, currently in a state of loss [1] Group 2 - The total funds raised from the IPO amounted to 2.276 billion yuan, with net proceeds of 2.244 billion yuan after deducting issuance costs of 31.5657 million yuan [1] - The actual funds raised were 251 million yuan less than the planned 2.495 billion yuan, which was intended for various vaccine development and production projects [1] - The total issuance costs for the IPO were 31.5657 million yuan, with Huatai United Securities receiving a total of 22 million yuan in underwriting and sponsorship fees [1] Group 3 - On May 30, 2023, Hualan Vaccine announced its 2022 annual equity distribution plan, which includes a cash dividend of 3.00 yuan for every 10 shares and a capital reserve conversion of 5 additional shares for every 10 shares held [2] - The record date for the equity distribution was set for June 6, 2023, with the ex-dividend date on June 7, 2023 [2]