Hualan Vac(301207)

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华兰疫苗:获得《药物临床试验批准通知书》
Mei Ri Jing Ji Xin Wen· 2025-08-13 07:58
(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》。 ...
华兰疫苗:冻干b型流感嗜血杆菌结合疫苗药物临床试验获批
Zheng Quan Shi Bao Wang· 2025-08-13 07:53
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]
华兰疫苗:冻干b型流感嗜血杆菌结合疫苗获药物临床试验批准
Xin Lang Cai Jing· 2025-08-13 07:53
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]
华兰疫苗(301207.SZ):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
Ge Long Hui A P P· 2025-08-13 07:53
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]
华兰疫苗: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
Mei Ri Jing Ji Xin Wen· 2025-08-13 07:51
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]
华兰疫苗(301207) - 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
2025-08-13 07:42
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 ...
华兰疫苗股价微跌0.22% 生物制品板块企业受关注
Jin Rong Jie· 2025-08-08 16:27
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]
华兰疫苗跌1.15% 2022年上市见顶募22.76亿元
Zhong Guo Jing Ji Wang· 2025-08-05 08:32
中国经济网北京8月5日讯华兰疫苗(301207)(301207.SZ)今日收报18.87元,跌幅1.15%。 华兰疫苗于2022年2月18日在深交所创业板上市,公开发行的股票数量为4001.00万股,发行价格为56.88 元/股,保荐机构(主承销商)为华泰联合证券有限责任公司,保荐代表人为贾鹏、刘晓宁。 华兰疫苗首次公开发行股票的发行费用总额为3156.57万元,其中,华泰联合证券有限责任公司获得承 销费用、保荐费用合计2200.00万元。 2023年5月30日,华兰疫苗发布2022年年度权益分派实施公告。公司2022年年度权益分派方案为:以公 司现有总股本400,010,000股为基数,向全体股东每10股派3.00元人民币现金,同时,以资本公积金向全 体股东每10股转增5股。本次权益分派股权登记日为2023年6月6日,除权除息日为2023年6月7日。 华兰疫苗首次公开发行股票募集资金总额为22.76亿元,扣除含税发行费用3156.57万元,实际募集资金 净额为22.44亿元。华兰疫苗此次募集资金比原计划少2.51亿元,公司2021年11月12日披露招股书注册稿 显示,公司拟募集资金24.95亿元,分别用于流 ...
生物制品上市公司董秘PK:辽宁成大邱闯成为业内唯一博士董秘 今年5月刚刚上任
Xin Lang Zheng Quan· 2025-08-01 05:24
Core Insights - The report highlights that the total salary of A-share listed company secretaries in 2024 reached 4.086 billion yuan, with an average annual salary of 754,300 yuan [1] - A total of 1,144 secretaries earned over 1 million yuan annually, accounting for more than 21% of the total [1] Salary Distribution - The average annual salary for secretaries in the A-share biopharmaceutical sector is 1.01 million yuan [5] - The distribution of salaries is as follows: below 500,000 yuan (15%), 500,000-1,000,000 yuan (41%), 1,000,000-2,000,000 yuan (38%), 2,000,000-3,000,000 yuan (4%), and above 3,000,000 yuan (2%) [5] Age and Education Distribution - The age distribution of secretaries shows that those aged 40-50 constitute 61%, while those over 50 account for 15%, and those aged 30-40 make up 18% [1] - In terms of education, 52% of secretaries hold a bachelor's degree, while 44% have a master's degree, and only 2% possess a doctoral degree [3] Investor Engagement - There is significant variation in the number of investor meetings held by companies, with 43% of companies hosting fewer than 10 meetings annually [7] - The top five companies with the highest number of investor meetings are: Bohui Innovation (1,500 meetings), Jindike (777 meetings), Nearshore Protein (681 meetings), Sailun Biotech (549 meetings), and Kanghua Biotech (504 meetings) [9]
生物制品上市公司董秘PK:康乐卫士任恩奇为行业最年轻董秘 任职已满1年年薪38.32万元
Xin Lang Zheng Quan· 2025-08-01 05:20
Core Insights - The report highlights that the total salary of A-share listed company secretaries in 2024 reached 4.086 billion yuan, with an average annual salary of 754,300 yuan [1] - Over 21% of company secretaries earn more than 1 million yuan annually, indicating a significant portion of high earners in this role [1] Salary Distribution - The average annual salary for company secretaries in the biopharmaceutical sector is 1.01 million yuan, with the distribution of salaries as follows: below 500,000 yuan (15%), 500,000-1,000,000 yuan (41%), 1,000,000-2,000,000 yuan (38%), 2,000,000-3,000,000 yuan (4%), and above 3,000,000 yuan (2%) [5] - The top five highest-paid company secretaries have salaries of 3.2565 million yuan, 2.5345 million yuan, 2.2809 million yuan, 1.9265 million yuan, and 1.89 million yuan, with their tenure at the companies ranging from less than one year to 15 years [7] Age and Educational Background - The age distribution of company secretaries shows that those aged 40-50 constitute 61%, while those over 50 account for 15%, and those under 30 make up 6% [1][3] - The educational background indicates that 52% hold a bachelor's degree, 44% have a master's degree, and only 2% possess a doctoral degree, with the latter represented by just one individual [3] Investor Engagement - There is a significant variance in the number of investor meetings held by companies, with 43% of companies hosting fewer than 10 meetings annually, while only 2% have more than 1,000 meetings [9] - The five companies with the highest number of investor meetings are reported to have 1,500, 777, 681, 549, and 504 meetings, respectively [9]