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国家卫健委医药卫生科技发展研究中心主任郑忠伟:中国疫苗研发有优势也有不足 国际临床方面尚有差距
Mei Ri Jing Ji Xin Wen· 2025-11-24 07:52
每经记者|陈星 实习生 范芊芊 每经编辑|文多 4月10日,2021全国疫苗与健康大会在成都召开。国家卫生健康委医药卫生科技发展研究中心主任、国 务院联防联控机制科研攻关组疫苗研发工作组组长郑忠伟参与了"由新冠疫苗看中国疫苗创新"为主题的 圆桌访谈。他表示,对于中国疫苗研发,在坚定自信的同时,也要了解不足。 "从此次新冠疫苗研发来看,我们所有的中国人既要有中国自信,也要有中国冷静。"他说。 封面图片来源:摄图网 他指出,在生物医药领域,我国有一些国家优势,包括体制、组织、文化优势;而不足则体现在基础研 究、载体平台、组织研发等方面,尤其在国际临床项目上与国外差距明显。 那么国际临床项目上的差距如何补足?他说,"十四五"期间,国家大概要投入40亿元左右用于推进病原 学和免疫技术体系方面的研发项目。其次,重大传染病专项培养技术也会在"十四五"期间尽早投入。另 外,目前一些疫苗方面的突破得益于企业的储备。 ...
国家卫健委郑忠伟:中国新冠疫苗全球使用已近2.5亿剂次 安全性非常良好
Mei Ri Jing Ji Xin Wen· 2025-11-24 07:52
每经记者|陈星 实习生 范芊芊 每经编辑|文多 4月10日,2021全国疫苗与健康大会在成都召开。会上,国家卫健委医药卫生科技发展研究中心主任、 国务院联防联控机制科研攻关组疫苗研发工作组组长郑忠伟参与了"由新冠疫苗看中国疫苗创新"为主题 的圆桌访谈。 国家卫健委医药卫生科技发展研究中心是在应急状态下成立的,随着一些疫苗进入三级临床试验以及上 市等阶段,后续研究中心的工作逐渐进入常态化。 那如何弥补不足?他说,"十四五"期间,国家大概要投入40亿元左右用于推进病原学和防疫技术体系方 面的研发项目。其次,重大传染病防治专项也会在"十四五"期间尽早投入。另外,目前一些疫苗方面的 突破得益于企业的储备。"俗话说,宁可备而不用,只有这样,我国的科技进步才真正能够追上全球领 先的机构、国家等。"他说。 目前,国内开始推进对大规模人群的中国新冠疫苗接种,但一些公众由于担忧疫苗的安全性、有效性等 而犹豫。 对此,郑忠伟指出,我们要对中国新冠疫苗充满信心。 他介绍,到昨天为止,中国新冠疫苗在全球的使用已经接近2.5亿剂次。从安全性的横向对比来看,中 国新冠肺炎疫苗的安全性非常良好。纵向数据来看,中国新冠肺炎疫苗实际使用的不良 ...
Valneva(VALN) - 2025 Q3 - Earnings Call Transcript
2025-11-20 15:02
Valneva (NasdaqGS:VALN) Q3 2025 Earnings Call November 20, 2025 09:00 AM ET Company ParticipantsJoshua Drumm - VP of Global Investor RelationsThomas Lingelbach - CEOPeter Bühler - CFOMaury Raycroft - Equity ResearchVamil Divan - Managing DirectorTheodora Rowe Beadle - Equity Research AssociateConference Call ParticipantsRomy O'Connor - Equity Research Analyst for Life Sciences and HealthcareOperatorGood day, and thank you for standing by. Welcome to the Valneva 9 Month 2025 Financial Results Conference Call ...
康希诺(688185.SH):吸入用肺结核疫苗(5型腺病毒载体)于印度尼西亚启动I期临床试验并完成首例受试者入组
Ge Long Hui· 2025-11-14 20:54
目前,卡介苗是全球唯一可用于预防结核病的疫苗,在全球范围内被广泛接种,其对预防婴幼儿结核病 发挥重要作用,但卡介苗保护力会随时间减弱,无法通过加强免疫接种增强疫苗的保护效果。针对此不 足,公司研发了第一代全球创新的结核病加强疫苗用于卡介苗接种人群,该款疫苗于加拿大完成了Ia及 Ib期临床试验,临床数据证明了该候选疫苗的安全性和作为卡介苗加强疫苗的有效性,以及黏膜免疫的 优越性。 该I期临床试验于印度尼西亚开展,目的是在18-49岁的成年人中探究接种一剂吸入用肺结核疫苗(5型 腺病毒载体)的安全性和免疫原性。 格隆汇11月13日丨康希诺(688185.SH)公布,公司开发的吸入用肺结核疫苗(5型腺病毒载体)(以下简 称"吸入用结核病加强疫苗")近日于印度尼西亚启动I期临床试验,并完成I期临床首例受试者入组。 ...
百克生物:公司无被收购计划
Zheng Quan Ri Bao· 2025-11-14 13:41
Core Viewpoint - The company has no plans for acquisition and is focused on its long-term development while enhancing its core competitiveness in the vaccine sector [2] Group 1: Company Strategy - The company emphasizes high-quality development and is actively advancing its research, production, and sales efforts [2] - The company is committed to improving its product pipeline, particularly in adult vaccines, multi-valent vaccines, and mRNA vaccines [2] Group 2: Market Environment - The company acknowledges the opportunities and challenges presented by an aging population and the emergence of new technologies and products [2] - The company aims to enhance its investment value and shareholder return capabilities based on quality improvement [2]
康希诺生物涨超5% 吸入用肺结核疫苗I期临床试验在印尼启动
Zhi Tong Cai Jing· 2025-11-14 02:54
此外,瑞银此前研报指出,将康希诺生物2026及2027年收入预测分别上调22%及下调9%。康希诺生物 管理层表示,MCV4疫苗在今年首三季贡献6.62亿元人民币(下同)收入,同比增长约28%,主要因适用 年龄群扩大,以及持续渠道渗透。MCV4已于第三季开始出口至印尼,该行估计今年将录得数百万元销 售额。另外,PCV13i自今年中上市以来,已进入约12个省份,管理层目标在年底前覆盖半数省份,并 于明年拓展至其他市场。 消息面上,康希诺生物发布公告,公司开发的吸入用肺结核疫苗(5型腺病毒载体)近日于印度尼西亚正 式启动I期临床试验,并完成I期临床试验首例受试者入组。据悉,I期临床试验于印度尼西亚开展,目的 是在18至49岁的成年人中探究接种一剂吸入用结核病加强疫苗的安全性和免疫原性。 康希诺生物(06185)涨超5%,截至发稿,涨5.03%,报46.38港元,成交额1611.81万港元。 ...
GeoVax Labs(GOVX) - 2025 Q3 - Earnings Call Transcript
2025-11-13 22:30
Financial Data and Key Metrics Changes - For the nine months ended September 30, 2025, the company reported revenues of $2.5 million, down from $3.1 million in 2024, primarily due to the termination of the BARDA Project NextGen contract [13][15] - Research and development expenses for Q3 2025 were $5 million, compared to $7.4 million in 2024, with a nine-month total of $15.1 million versus $16.1 million in 2024 [13][14] - The overall net loss for Q3 2025 was $6.3 million, compared to $5.8 million in 2024, and the year-to-date net loss was $17 million versus $16.7 million in 2024 [15] Business Line Data and Key Metrics Changes - The company is advancing multiple product candidates, including GEO-MVA, GEO-CM04S1, and Gadeptin, with a focus on addressing unmet healthcare needs [4][11] - GEO-MVA has received guidance from the European Medicines Agency for an expedited development path, allowing the company to bypass earlier clinical trial phases [5][6] - GEO-CM04S1 is recognized as a critical vaccine for immunocompromised adults, with ongoing studies focusing on this population [7][8] Market Data and Key Metrics Changes - There is significant government interest in U.S.-based supply chains for vaccines, reflecting a shift towards onshoring initiatives [6] - The company is experiencing increased interest from industry partners and funding organizations, particularly in relation to its vaccine candidates [4][5] Company Strategy and Development Direction - The company aims to develop innovative cancer therapies and infectious disease vaccines, with a focus on expedited registration pathways [11][12] - Strategic partnerships and collaborations are being pursued to support the development and commercialization of its product candidates [11][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress and outlook for its product portfolio, highlighting the potential for GEO-MVA to address global vaccine needs [4][5] - The company is actively engaging with stakeholders, including government entities and international organizations, to advance its vaccine programs [6][38] Other Important Information - The company is exploring various funding strategies to support its clinical programs, including strategic partnerships and non-dilutive funding [15] - The focus remains on advancing clinical evaluations for GEO-MVA and GEO-CM04S1, as well as Gadeptin for oncology applications [11][12] Q&A Session Summary Question: Is there a scenario that could lead to MVA being used by governments before clinical trials? - Management indicated that emergency use licensing through WHO may be possible, but not prior to clinical evaluation [19][20] Question: Can you provide insights on potential collaborations or partnerships? - Management stated that they hold worldwide rights for their product assets and are open to proposals from potential partners, focusing on global registration [27][28] Question: What are the plans for the needle-free administration method for GEO-MVA? - The company is evaluating non-traditional delivery methods in collaboration with Vaxxas and is in discussions regarding manufacturing plans [32][34] Question: Which regions are most supportive of the vaccine programs? - Management highlighted significant interest in the Southern Hemisphere for GEO-MVA and ongoing concerns regarding mpox outbreaks in various regions [38][40] Question: Will there be a biosimilar version of Pembro available by the time Gadepin is approved? - Management expressed uncertainty but noted potential interest in developing Gadepin with various immune checkpoint inhibitors [43]
双价流感疫苗Ⅰ期临床启动,中慧生物-B疫苗管线布局持续丰富
Zhi Tong Cai Jing· 2025-11-13 11:46
Group 1 - Jiangsu Zhonghui Yuantong Biotechnology Co., Ltd. and its subsidiary Yihui Biotechnology (Shanghai) Co., Ltd. have successfully initiated Phase I clinical trials for two new influenza vaccines: "Influenza Virus Subunit Vaccine (Adjuvant)" and "Quadrivalent Influenza Virus Subunit Vaccine (Adjuvant)" in Hubei province [1] - The World Health Organization (WHO) reports that there are approximately 3 to 5 million severe cases of influenza globally each year, with an average of about 88,000 excess deaths due to respiratory diseases caused by influenza in China from 2010 to 2015 [3] - The overall vaccination rate for influenza in China remains low, with only 3.84% during the 2022-2023 flu season, indicating a significant challenge in establishing an effective immune barrier against influenza [3] Group 2 - The "Adjuvanted Influenza Virus Subunit Vaccine" is designed to meet the vaccination needs of different populations, particularly targeting individuals aged 65 and older, utilizing the company's established platform technology and new adjuvants [4] - The vaccine is administered via intramuscular injection in the deltoid muscle, with low-dose and high-dose groups receiving 0.25ml and 0.5ml per dose, respectively, over a total of one dose on day 0 [4] - Preclinical studies indicate that the adjuvanted influenza virus subunit vaccine significantly enhances antibody levels and neutralizing antibody titers, providing a superior option for the elderly population to combat influenza [4] Group 3 - Zhonghui Biotechnology is focused on the research, development, manufacturing, and commercialization of innovative vaccines and traditional vaccines using new technologies, with a continuous increase in R&D investment [5] - The company has received clinical approval for several products, including recombinant zoster vaccine, adjuvanted influenza virus subunit vaccine, and lyophilized human rabies vaccine, with multiple innovative vaccine pipelines under development [6] - The company has established large-scale production capabilities, with a first-phase facility covering approximately 68 acres and equipped with international-level GMP production lines for influenza raw materials and formulations [6]
康希诺生物(06185):吸入用结核病加强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
智通财经网· 2025-11-13 08:56
I期临床试验于印度尼西亚开展,目的是在18至49岁的成年人中探究接种一剂吸入用结核病加强疫苗的 安全性和免疫原性。 目前,卡介苗是全球唯一可用于预防结核病的疫苗,在全球范围内被广泛接种,其对预防婴幼儿结核病 发挥重要作用,但卡介苗保护力会随时间减弱,无法通过加强免疫接种增强疫苗的保护效果。针对此不 足,公司研发了第一代全球创新结核病加强疫苗用于卡介苗接种人群,结核病加强疫苗于加拿大完成了 Ia及Ib期临床试验,临床试验数据证明了结核病加强疫苗作为候选疫苗的安全性和作为卡介苗加强疫苗 的有效性,以及黏膜免疫的优越性。 基于吸入用新冠疫苗开发的技术累积,公司建立了完整的吸入药学、质量控制体系,升级第一代产品, 同时增加了抗原组分,开发了吸入用结核病加强疫苗,通过雾化吸入的方式递送,有望可以激发肺部免 疫应答,从而清除结核菌,控制潜伏感染,并可实现预防感染的效果。 智通财经APP讯,康希诺生物(06185)发布公告,公司开发的吸入用肺结核疫苗(5型腺病毒载体)近日于 印度尼西亚正式启动I期临床试验,并完成I期临床试验首例受试者入组。 ...
康希诺生物:吸入用结核病加强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
Ge Long Hui· 2025-11-13 08:56
格隆汇11月13日丨康希诺生物(06185.HK)宣布,公司开发的吸入用肺结核疫苗(5型腺病毒载体)("吸入用 结核病加强疫苗")近日于印度尼西亚正式启动I期临床试验,并完成I期临床试验首例受试者入组。 目前,卡介苗是全球唯一可用于预防结核病的疫苗,在全球范围内被广泛接种,其对预防婴幼儿结核病 发挥重要作用,但卡介苗保护力会随时间减弱,无法通过加强免疫接种增强疫苗的保护效果。针对此不 足,公司研发了第一代全球创新结核病加强疫苗("结核病加强疫苗")用于卡介苗接种人群,结核病加强 疫苗于加拿大完成了Ia及Ib期临床试验,临床试验数据证明了结核病加强疫苗作为候选疫苗的安全性和 作为卡介苗加强疫苗的有效性,以及黏膜免疫的优越性。 基于吸入用新冠疫苗开发的技术累积,公司建立了完整的吸入药学、质量控制体系,升级第一代产品, 同时增加了抗原组分,开发了吸入用结核病加强疫苗,通过雾化吸入的方式递送,有望可以激发肺部免 疫应答,从而清除结核菌,控制潜伏感染,并可实现预防感染的效果。 ...