疫苗研发
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康希诺生物(06185) - 自愿公告 - 吸入用结核病加强疫苗於印度尼西亚啟动I期临床试验并完成首...
2025-11-13 08:48
CanSino Biologics Inc. 康希諾生物股份公司 (於中華人民共和國註冊成立的股份有限公司) (股份代號:6185) 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負 責,對其準確性或完整性亦不發表任何聲明,並明確表示,概不就因本公告全部 或任何部分內容所產生或因依賴該等內容而引致的任何損失承擔任何責任。 基 於 吸 入 用 新 冠 疫 苗 開 發 的 技 術 累 積,本 公 司 建 立 了 完 整 的 吸 入 藥 學、質 量 控 制體系,升級第一代產品,同時增加了抗原組分,開發了吸入用結核病加強疫苗, 通過霧化吸入的方式遞送,有望可以激發肺部免疫應答,從而清除結核菌,控制 潛伏感染,並可實現預防感染的效果。 – 1 – I期臨床試驗於印度尼西亞開展,目的是在18至49歲的成年人中探究接種一劑吸 入用結核病加強疫苗的安全性和免疫原性。 本公司股東及潛在投資者在買賣本公司股份時務請審慎行事。 承董事會命 康希諾生物股份公司 自願公告 吸入用結核病加強疫苗於印度尼西亞 啟 動I期臨床試驗並完成首例受試者入組 本 公 告 由 康 希 諾 生 物 股 份 公 司(「本公司」)自 願 ...
康希诺:吸入用肺结核疫苗于印度尼西亚启动I期临床试验并完成首例受试者入组
Xin Lang Cai Jing· 2025-11-13 08:41
康希诺11月13日公告,公司开发的吸入用肺结核疫苗(5型腺病毒载体)近日于印度尼西亚启动I期临床 试验,并完成首例受试者入组。该疫苗为第一代全球创新的结核病加强疫苗,通过雾化吸入的方式递 送,有望激发肺部免疫应答,控制潜伏感染,并可实现预防感染的效果。 ...
中慧生物-B(02627) - 自愿性公告 - 四价流感病毒亚单位疫苗(佐剂)及三价流感病毒亚单位疫...
2025-11-13 08:31
四價流感病毒亞單位疫苗(佐劑) 及三價流感病毒亞單位疫苗(佐劑) 的I期臨床試驗啟動 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不對因本公告全部或任何部份內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 Ab&B Bio-Tech CO., LTD. JS 江蘇中慧元通生物科技股份有限公司 (於中華人民共和國成立的股份有限公司) (股份代號:2627) 自願性公告 本公告由江蘇中慧元通生物科技股份有限公司(「本公司」或「中慧生物」,連同其 附屬公司,統稱「本集團」)自願刊發,以告知本公司股東及潛在投資者有關本集 團最新業務發展的資料。 本公司董事(「董事」)會(「董事會」)欣然宣佈,本集團近期啟動本集團四價流感 病毒亞單位疫苗(佐劑)及三價流感病毒亞單位疫苗(佐劑)的I期臨床試驗。我們 已於2024年7月就在研四價流感病毒亞單位疫苗(佐劑)及於2024年10月就在研三 價流感病毒亞單位疫苗(佐劑)取得中華人民共和國國家藥品監督管理局的新藥臨 床試驗申請批准。 由於隨著年齡的增長,免疫功能自然下降,流感對老年人,尤其是6 ...
智飞生物:冻干水痘灭活疫苗临床试验申请获受理
Mei Ri Jing Ji Xin Wen· 2025-11-12 09:32
Core Viewpoint - Zhifei Biological has received a clinical trial application acceptance notice for its lyophilized varicella inactivated vaccine from the National Medical Products Administration, allowing it to proceed with clinical trials if no objections are raised within 60 days [1] Company Summary - The vaccine is developed by Anhui Zhifei Longkema Biological Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Zhifei Biological [1] - The acceptance number for the clinical trial application is CXSL2500962 [1]
智飞生物:冻干水痘灭活疫苗临床试验申请获得受理
Zhi Tong Cai Jing· 2025-11-12 09:31
Core Viewpoint - Zhifei Biological (300122.SZ) has received a clinical trial application acceptance notice from the National Medical Products Administration for its lyophilized varicella inactivated vaccine developed by its wholly-owned subsidiary, Anhui Zhifei Longkema Biological Pharmaceutical Co., Ltd [1] Group 1 - The clinical trial acceptance number is CXSL2500962, and the company can commence clinical trials within 60 days if no negative or questioning opinions are received from the drug review center [1] - The lyophilized varicella inactivated vaccine utilizes an innovative inactivation technology route, with both the production cell strains and virus strains being independently developed by the company [1] - This product demonstrates significant safety advantages and is suitable for individuals aged 12 months and older to prevent varicella, providing safer vaccination options for healthy individuals as well as those with immune deficiencies or contraindications [1]
长春高新:子公司百克生物吸附无细胞百(二组分)白破联合疫苗(成人及青少年用)临床试验申请获得批准
Ge Long Hui A P P· 2025-11-12 09:13
格隆汇11月12日|长春高新(000661.SZ)公告称,公司子公司百克生物收到国家药品监督管理局对其吸 附无细胞百(二组分)白破联合疫苗(成人及青少年用)的《药物临床试验批准通知书》。该疫苗是一种可 以同时预防青少年及成人百日咳、白喉、破伤风的疫苗,接种对象为10周岁及以上人群。若该疫苗顺利 完成临床试验并获批上市,将进一步完善公司疫苗研发管线,丰富公司联合疫苗产品矩阵,有助于公司 优化产品结构和主营业务的全面发展。 ...
长春高新(000661.SZ):子公司吸附无细胞百(二组分)白破联合疫苗(成人及青少年用)临床试验申请获得批准
Ge Long Hui A P P· 2025-11-12 09:13
Core Viewpoint - Changchun High-tech's subsidiary, Baike Biological, has received approval from the National Medical Products Administration for clinical trials of an acellular combined vaccine for adolescents and adults, aimed at preventing whooping cough, diphtheria, and tetanus [1][2] Group 1: Vaccine Approval and Market Context - The approved vaccine is designed for individuals aged 10 and above, stimulating immune response to prevent invasive infections caused by whooping cough, diphtheria, and tetanus [1] - There has been an increasing incidence of whooping cough among adolescents and adults in recent years, prompting the recommendation for vaccination every 10 years in developed countries [1] - Currently, China's immunization program primarily targets infants, with no approved combined vaccine for adolescents and adults [1] Group 2: Technological Advancements and Business Implications - The vaccine developed by Baike Biological utilizes a new acellular technology, replacing the traditional co-purification process, and includes inactivated components of whooping cough toxin, filamentous hemagglutinin, diphtheria toxin, and tetanus toxin [2] - The vaccine's formulation with an aluminum-CpG adjuvant system enhances immune response, offering high purity and consistency [2] - Successful completion of clinical trials and subsequent market approval will enhance the company's vaccine development pipeline, diversify its product offerings, and create new growth opportunities for the company's performance [2]
长春高新:子公司吸附无细胞百(二组分)白破联合疫苗(成人及青少年用)临床试验申请获得批准
Ge Long Hui· 2025-11-12 09:07
Core Viewpoint - Changchun High-tech's subsidiary, Baike Biological, has received approval from the National Medical Products Administration for clinical trials of its acellular combined diphtheria, tetanus, and pertussis vaccine for adolescents and adults, addressing the rising incidence of whooping cough among this demographic [1][2]. Group 1 - The approved vaccine is designed to prevent whooping cough, diphtheria, and tetanus in individuals aged 10 and above, stimulating immune responses to prevent invasive infections [1]. - There has been an increasing trend in the incidence of whooping cough among adolescents and adults both domestically and internationally, prompting recommendations for vaccination every 10 years in developed countries [1]. - Currently, China's immunization program primarily targets infants, with no approved combined diphtheria, tetanus, and pertussis vaccine for adolescents and adults [1]. Group 2 - The vaccine developed by Baike Biological utilizes a new formulation that includes inactivated pertussis toxin, filamentous hemagglutinin, diphtheria toxin, and tetanus toxin, along with an aluminum-CpG adjuvant system to enhance immune response [2]. - If the clinical trials are successful and the vaccine is approved for market release, it will enhance the company's vaccine research pipeline and diversify its product offerings, contributing to overall business growth and providing high-quality vaccination options to the public [2].
长春高新:子公司百克生物吸附无细胞百(二组分)白破联合疫苗(成人及青少年用)临床试验申请获得批准
Xin Lang Cai Jing· 2025-11-12 09:05
Core Viewpoint - Changchun High-tech's subsidiary, Baike Bio, has received approval for clinical trials of an acellular combined vaccine for adolescents and adults, which aims to prevent whooping cough, diphtheria, and tetanus [1] Group 1 - The vaccine is intended for individuals aged 10 years and older [1] - Successful completion of clinical trials and subsequent approval for market launch will enhance the company's vaccine research pipeline [1] - This development will enrich the company's portfolio of combined vaccines, aiding in optimizing product structure and overall business growth [1]
百克生物:青少年及成人百白破疫苗临床试验申请获批准
Xin Lang Cai Jing· 2025-11-12 07:43
百克生物公告,公司近日收到国家药品监督管理局下发的吸附无细胞百(二组分)白破联合疫苗(成人 及青少年用)的《药物临床试验批准通知书》。该疫苗是一种可以同时预防青少年及成人百日咳、白 喉、破伤风的疫苗,接种对象为10周岁及以上人群。若顺利完成临床试验并获批上市,将进一步完善公 司疫苗研发管线,丰富公司联合疫苗产品矩阵,有助于公司优化产品结构和主营业务的全面发展。 ...