BioKangtai(300601)

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 生物制品板块8月20日跌0.42%,荣昌生物领跌,主力资金净流出8.57亿元
 Zheng Xing Xing Ye Ri Bao· 2025-08-20 08:41
从资金流向上来看,当日生物制品板块主力资金净流出8.57亿元,游资资金净流入2.95亿元,散户资金净 流入5.62亿元。生物制品板块个股资金流向见下表: 证券之星消息,8月20日生物制品板块较上一交易日下跌0.42%,荣昌生物领跌。当日上证指数报收于 3766.21,上涨1.04%。深证成指报收于11926.74,上涨0.89%。生物制品板块个股涨跌见下表: | 代码 | 名称 | 收盘价 | 涨跌幅 | 成交量(手) | 成交额(元) | | --- | --- | --- | --- | --- | --- | | 688319 | 欧林生物 | 33.11 | 6.09% | 17.16万 | 5.59亿 | | 000534 | 万泽股份 | 17.55 | 4.84% | 34.99万 | 6.03亿 | | 000518 | *ST四环 | 2.30 | 2.68% | 18.92万 | 4320.70万 | | 300601 | 康泰生物 | 17.74 | 2.54% | 1 36.24万 | 6.38亿 | | 688443 | 智翔全泰 | 33.61 | 1.69% | 5.48万 |  ...
 中信建投:创新疫苗管线后续研发节点及对外授权预期值得关注
 Di Yi Cai Jing· 2025-08-20 00:09
 Group 1 - The overall number of vaccine batch approvals in the first half of 2025 is 1,629, representing a year-on-year decrease of 17% [1] - Certain vaccines, such as rabies and HPV vaccines, have seen significant growth in batch approvals, while others like polio, meningitis, and measles-mumps-rubella vaccines have experienced substantial declines [1] - Several key vaccines have received approval for market launch in the first half of the year, including CanSino's PCV13 and Wantai's 9-valent HPV vaccine [1]   Group 2 - Multiple products are currently in the review stage for market approval, including Zhifei's PCV15 and MCV4, as well as Kangtai's IPV and quadrivalent influenza vaccines [1] - It is anticipated that sales of certain products in the second half of 2025 may improve year-on-year, driven by new product launches contributing to revenue growth [1] - The ongoing development of innovative vaccine pipelines and expectations for external licensing are areas of interest, along with the implications of recent equity changes in some companies and the potential impact of new shareholders [1]
 康泰生物:三价流感病毒裂解疫苗(MDCK细胞)药物临床试验获批准
 Zheng Quan Shi Bao Wang· 2025-08-18 08:38
 Core Viewpoint - Kangtai Biological (300601) has received approval from the National Medical Products Administration for clinical trials of its trivalent influenza virus split vaccine, indicating a significant advancement in its product pipeline [1]   Company Summary - The trivalent influenza virus split vaccine is developed in collaboration with Lanzhou Bailing Biotechnology Co., Ltd. [1] - The vaccine is intended for individuals aged 3 years and older, aiming to stimulate the immune system to produce antibodies against influenza viruses [1]   Industry Summary - The approval for clinical trials reflects ongoing efforts in the biopharmaceutical industry to enhance vaccine development, particularly in response to seasonal influenza outbreaks [1]
 康泰生物:获得《药物临床试验批准通知书》
 Mei Ri Jing Ji Xin Wen· 2025-08-18 08:22
康泰生物8月18日晚间发布公告称,深圳康泰生物制品股份有限公司关于三价流感病毒裂解疫苗获得药 物临床试验批准通知书的公告。公司和兰州百灵生物技术有限公司研发的三价流感病毒裂解疫苗 (MDCK细胞)近日获得国家药品监督管理局出具的《药物临床试验批准通知书》,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,同意本品进行临床试验。 (文章来源:每日经济新闻) ...
 康泰生物:三价流感病毒裂解疫苗(MDCK细胞)获得药物临床试验批准通知书
 Mei Ri Jing Ji Xin Wen· 2025-08-18 08:15
 Core Viewpoint - Kangtai Biological (300601.SZ) has received approval from the National Medical Products Administration for its trivalent influenza virus split vaccine (MDCK cell) for clinical trials, marking a significant step in its vaccine development efforts [1]   Company Summary - The trivalent influenza virus split vaccine is designed for individuals aged 3 years and older, aiming to stimulate the immune system to produce antibodies against influenza viruses [1] - This vaccine is intended for the prevention of influenza caused by vaccine-related strains of the virus [1] - Currently, there are no approved trivalent influenza virus split vaccines (MDCK cell) available in the domestic market [1]   Industry Summary - The approval of this vaccine follows the precedent set by international manufacturers such as Seqirus, which have successfully launched MDCK cell-based influenza vaccines [1] - The development of this vaccine could enhance the competitive landscape of influenza prevention in the domestic market [1]
 康泰生物(300601.SZ):三价流感病毒裂解疫苗(MDCK细胞)获得药物临床试验批准通知书
 Ge Long Hui A P P· 2025-08-18 08:12
 Core Viewpoint - Kangtai Biological (300601.SZ) has received approval from the National Medical Products Administration for clinical trials of its trivalent influenza virus split vaccine (MDCK cells) [1]   Company Summary - The trivalent influenza virus split vaccine is developed in collaboration with Lanzhou Bailing Biotechnology Co., Ltd. [1] - The vaccine is intended for individuals aged 3 years and older, aiming to stimulate the immune response against influenza viruses [1]   Industry Summary - The approval aligns with the requirements set forth by the Drug Administration Law and Vaccine Administration Law of the People's Republic of China [1] - The vaccine is designed to prevent influenza caused by vaccine-related virus strains, addressing public health needs [1]
 康泰生物:三价流感病毒裂解疫苗获药物临床试验批准
 Xin Lang Cai Jing· 2025-08-18 08:12
康泰生物公告,近日公司和兰州百灵生物技术有限公司研发的三价流感病毒裂解疫苗(MDCK细胞)获 得国家药品监督管理局出具的《药物临床试验批准通知书》。该疫苗适用于3周岁及以上人群,可刺激 机体产生抗流感病毒的免疫力,用于预防疫苗相关型别的流感病毒引起的流行性感冒。公司将尽快开展 相关临床试验工作。若该疫苗研发成功,将有利于进一步丰富公司产品布局,增强公司的核心竞争力和 市场地位。 ...
 康泰生物(300601) - 三价流感病毒裂解疫苗(MDCK细胞)药物临床试验批准通知书2025LP02063
 2025-08-18 08:02
CXSL2500428 2025LP02063 深圳康泰生物制品股份有限公司;兰州百灵生物技术有限公司: 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,2025年05月28日受理的三价 流感病毒裂解疫苗(MDCK细胞)符合药品注册的有关要求,同意在3岁及以上人群中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。 申请人提交的临床试验方案名称: 1.评价三价流感病毒裂解疫苗(MDCK细胞)在3周岁及以上人群中接种的安全性和初步免疫原性的随机、盲法、阳性对照 Ⅰ期临床试验(版本号:0.1,版本日期:2025年05月08日) 2.评价三价流感病毒裂解疫苗(MDCK细胞)在3周岁及以上人群中接种的免疫原性和安全性的随机、盲法、阳性对照Ⅲ期 临床试验(版本号:0.1,版本日期:2025年05月08日) 关注以下内容: (一)临床试验开展前,完成以下工作。 1.本品3批成品及各型别原液(各3批)经中检院检定合格后方可开展临床试验。 2.请完善半成品配制工艺研究,严格按照固定的配制点进行配制。临床试验样品应采用完善后的工艺配制,且相关制品安 全性风险不得高于毒理批。后续商业化批 ...
 康泰生物(300601) - 关于三价流感病毒裂解疫苗(MDCK细胞)获得药物临床试验批准通知书的公告
 2025-08-18 08:02
债券代码:123119 债券简称:康泰转 2 证券代码:300601 证券简称:康泰生物 公告编号:2025-061 深圳康泰生物制品股份有限公司 关于三价流感病毒裂解疫苗(MDCK 细胞) 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、完整,没有虚假记载、 误导性陈述或重大遗漏。 深圳康泰生物制品股份有限公司(以下简称"公司")和兰州百灵生物技术 有限公司研发的三价流感病毒裂解疫苗(MDCK细胞)近日获得国家药品监督管理 局出具的《药物临床试验批准通知书》,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, 同意本品进行临床试验。现将相关情况公告如下: 公司将根据药物临床试验批准通知书的要求,尽快开展相关临床试验工作。 该文件有效期为获得批准之日起 3 年,3 年内未有受试者签署知情同意书的,通 知书自行失效。 本次获得药物临床试验批准通知书的三价流感病毒裂解疫苗(MDCK 细胞) 适用于 3 周岁及以上人群,可刺激机体产生抗流感病毒的免疫力,用于预防疫苗 相关型别的流感病毒引起的流行性感冒。流行性感冒(也称 ...
 生物制品板块8月14日跌1.1%,康泰生物领跌,主力资金净流出8.83亿元
 Zheng Xing Xing Ye Ri Bao· 2025-08-14 08:27
证券之星消息,8月14日生物制品板块较上一交易日下跌1.1%,康泰生物领跌。当日上证指数报收于 3666.44,下跌0.46%。深证成指报收于11451.43,下跌0.87%。生物制品板块个股涨跌见下表: | 代码 | 名称 | 收盘价 | 涨跌幅 | 成交量(手) | 成交额(元) | | | --- | --- | --- | --- | --- | --- | --- | | 688331 | 荣昌生物 | 73.78 | 8.20% | 18.87万 | | 13.90 Z | | 688520 | 神州细胞 | 68.45 | 5.21% | 17.34万 | | 11.98亿 | | 603590 | 康辰药业 | 57.61 | 4.20% | 0 9.00万 | | 5.24亿 | | 002773 | 康弘药业 | 46.13 | 3.69% | 10.20万 | | 4.67亿 | | 616889 | 欧林生物 | 24.30 | 1.17% | 14.58万 | | 3.52亿 | | 688488 | 艾迪药业 | 16.80 | 0.90% | 20.46万 | | 3.45亿 | ...




