疫苗研发
Search documents
中慧生物-B(02627) - 自愿性公告 - 冻乾人用狂犬病疫苗(人二倍体细胞)的III期临床试验...
2025-12-08 09:08
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 凍乾人用狂犬病疫苗(人二倍體細胞)的III期臨床試驗啟動 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凍乾人用 狂犬病疫苗(人二倍體細胞)的III期臨床試驗。針對開發用於三種免疫方案的在研 疫苗,我們於2022年11月就Essen(五針)方案獲得中華人民共和國國家藥品監督 管理局核准的新藥臨床試驗許可,並於2023年4月獲批Zagreb(四針)和簡易四針 方案的補充臨床試驗申請。我們於2024年10月完成該在研疫苗的I期臨床試驗。 狂犬病是由一種狂 ...
康泰生物董事、副总裁刘建凯获“第十九届药学发展奖突出成就奖”
Zheng Quan Ri Bao Zhi Sheng· 2025-12-02 06:12
Group 1 - The core achievement of Kangtai Biologics is highlighted by the award of the "Outstanding Achievement Award" to Liu Jiankai, the Vice President of the company, recognizing significant contributions to the pharmaceutical field [1] - The 19th Pharmaceutical Development Award ceremony was held in Beijing, emphasizing the importance of breakthrough innovations in the medical and health sectors [1] - A vaccine innovation forum was co-organized by Kangtai Minhai, focusing on cutting-edge vaccine research and industrialization paths, featuring discussions from prominent experts in the field [1] Group 2 - Kangtai Minhai has undertaken nine national-level research projects and received four provincial and ministerial science and technology awards since its establishment [2] - The company has launched 12 vaccine products, including the domestically first four-component vaccine and the globally first dual-carrier 13-valent pneumococcal conjugate vaccine [2] - Kangtai Minhai is currently developing vaccines for Klebsiella pneumoniae, a five-component vaccine, and a hepatitis B treatment vaccine, aiming to become a leading enterprise covering the entire hepatitis B process [2]
智飞生物获美国及欧洲发明专利授权,加速全球化创新布局
Huan Qiu Wang· 2025-11-27 13:17
Core Insights - Zhifei Biological's subsidiary, Beijing Zhifei Lvzhu, has successfully obtained invention patent certificates from the U.S. Patent and Trademark Office and the European Patent Office for a combined vaccine targeting respiratory syncytial virus (RSV) infection, showcasing the company's strong independent research and development capabilities and marking a significant recognition of its technological innovation in global core markets [1][3] Group 1: Patent and Innovation - The RSV combined vaccine patent is a significant achievement resulting from deep collaboration between Zhifei Lvzhu and Beijing Jiaotong University, addressing the urgent clinical need for effective preventive measures against RSV, a major pathogen causing lower respiratory infections in infants and the elderly [3] - The patented technology enhances immune response efficiency and broad-spectrum protection through innovative antigen design and delivery strategies, providing safer and more effective preventive measures for high-risk populations [3] - Zhifei Biological has strengthened its intellectual property system, achieving over 60 domestic and international invention patent authorizations, with this patent previously authorized in China and Russia, supporting its globalization strategy and enhancing its core competitiveness in the respiratory disease vaccine sector [3][4] Group 2: International Expansion - The company is accelerating its product internationalization process and enhancing international collaboration, contributing positively to global infectious disease control and exploring new market opportunities [4] - Zhifei's self-developed products have been exported to over 10 countries, with clinical trials or registration efforts underway in nearly 20 countries, including successful market registration of tuberculosis diagnostic reagents in Indonesia and ongoing supply of quadrivalent meningococcal polysaccharide vaccine in several countries [4] - The company is expanding its international layout from preventive to therapeutic areas, with discussions ongoing for therapeutic products like insulin and semaglutide with multiple overseas entities [4][6] Group 3: Future Directions - Zhifei Biological plans to continue its commitment to innovative research and development, strengthen its global intellectual property protection network, and solidify its vaccine research and development technology, aiming to create a competitive product matrix and contribute more Chinese wisdom and solutions to global public health [6]
“父女档”带队,疫苗企业欧林生物闯关港交所
Mei Ri Jing Ji Xin Wen· 2025-11-26 15:11
Core Viewpoint - Company Olin Bio is seeking to list on the Hong Kong Stock Exchange to become an "A+H" listed company, aiming to raise funds for innovative vaccine research and to reduce reliance on its single core product, the adsorbed tetanus vaccine [1][6]. Group 1: Company Overview - Olin Bio was founded by industry veteran Fan Shaowen and his daughter Fan Fan, with a focus on the adsorbed tetanus vaccine as its core product [1][3]. - The company became the first private enterprise in China to produce and sell the adsorbed tetanus vaccine in 2017, which has since become its main revenue source [1][3]. Group 2: Financial Performance - In 2024, Olin Bio achieved a revenue of 589 million yuan, a year-on-year increase of 18.7%, with a net profit of 20.76 million yuan, up 18.2% [3]. - For the first half of 2025, the company reported a revenue of 306 million yuan, representing a year-on-year growth of 35.17%, and a net profit of approximately 13.2 million yuan, marking a turnaround from losses [3]. Group 3: Product and Market Dynamics - The adsorbed tetanus vaccine accounted for over 90% of the company's revenue in 2024, with sales reaching 536 million yuan, a 15.7% increase from the previous year [3]. - The company faces challenges from increasing competition in the vaccine market, despite having a first-mover advantage as the first private producer of the adsorbed tetanus vaccine [3][6]. Group 4: Research and Development - Olin Bio is developing four new Class 1 vaccines, including a recombinant Staphylococcus aureus vaccine and an oral recombinant Helicobacter pylori vaccine, with clinical trials planned for 2026 [4]. - The company has faced funding challenges, with a net cash flow from operating activities of -9.73 million yuan in 2024, indicating ongoing financial pressure [5][6]. Group 5: IPO and Market Conditions - The company has recently attempted to raise funds through a private placement, which was terminated due to market conditions and stock price fluctuations [5]. - Olin Bio plans to issue up to 25% of its total share capital in H-shares to fund research, production upgrades, and international expansion, but faces uncertainty regarding market acceptance due to its reliance on a single product and cash flow issues [6].
50亿元!昔日“疫苗之王”科兴生物拿下业内最大国际订单
Xin Lang Cai Jing· 2025-11-26 10:36
Core Viewpoint - Sinovac Biotech has secured a significant vaccine contract worth approximately 5 billion RMB, marking the largest international order for a Chinese vaccine company to date [1] Group 1: Contract Details - Sinovac signed two PDP (Product Development Partnership) projects with the Brazilian Ministry of Health to supply a total of approximately 60 million doses of varicella and rabies vaccines over the next 10 years, valued at over 700 million USD [1] - This contract represents the longest-term and highest-value international order obtained by a Chinese vaccine company [1] Group 2: Market and Regulatory Challenges - Sinovac has been under market scrutiny due to a delisting notice received from NASDAQ, which stated that unless the company requests a hearing, its securities will be suspended from trading on November 21, 2025 [1] - The delisting decision was attributed to the company's failure to comply with NASDAQ listing rules, specifically not submitting the 20-F annual report for the fiscal year ending December 31, 2024, by the extended deadline [1] - The delay in submitting the report was due to the resignation of the company's independent registered accounting firm [1] Group 3: Company Background and Financial Performance - Founded in 2001, Sinovac is a biotechnology and vaccine production company that became the first Chinese vaccine company to be listed in the U.S. through a reverse merger in 2003 [3] - The company experienced significant growth during the COVID-19 pandemic, reporting total revenue of 19.375 billion USD and a net profit of 8.46 billion USD in 2021 [4] - However, recent financial reports indicate a decline in sales, with 12.13 million USD in revenue for the first half of 2024, a decrease of 13.6% year-on-year, and a net loss of 6.86 million USD [4] - As of June 30, 2024, the company had cash and cash equivalents totaling 1.1 billion USD [4]
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
Financial Data and Key Metrics Changes - Total revenues reached EUR 127 million for the nine months ended September 30, 2025, representing a growth of almost 9% compared to EUR 112.5 million in the same period of 2024 [4][16] - Product sales increased to EUR 119.4 million, up 6.2% from EUR 112 million in the first nine months of 2024 [14][16] - Operating loss reported at EUR 53.9 million compared to an operating profit of EUR 34.2 million in the prior year, primarily due to the sale of a priority review voucher in 2024 [18] Business Line Data and Key Metrics Changes - IXIARO sales reached EUR 74.3 million, increasing 12.5% year-over-year, driven by sales to the U.S. Department of Defense and increased sales in Europe [14] - Ducoral sales decreased from EUR 22.3 million to EUR 21.5 million, impacted by foreign currency fluctuations and a transition to a new distributor in Germany [14][15] - Exchange sales significantly increased to EUR 7.6 million from EUR 1.8 million, including the supply of doses to combat chikungunya outbreaks [15] Market Data and Key Metrics Changes - The company is focusing on expanding into low- and middle-income countries (LMICs) for IXIARO, leveraging its differentiated product profile [22] - The chikungunya vaccine, VLA1553, is being positioned for growth in endemic regions and travel sectors, although the U.S. market remains suspended pending FDA review [10][46] Company Strategy and Development Direction - The company aims to achieve sustainable profitability post-approval and commercialization of the Lyme disease vaccine, VLA15, expected to be a major growth driver [21][22] - Valneva is actively identifying new opportunities for its R&D pipeline, aiming to build a coherent strategy for future vaccine candidates [24] - The company is focusing on operational efficiency and reducing cash burn, with a cash position of EUR 143.5 million as of September 30, 2025 [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming Lyme vaccine data, which is anticipated to be a significant catalyst for the company [22][56] - The company is preparing for potential growth in product sales and is focused on strategic investments in R&D [21][24] - There is uncertainty regarding funding for the Zika vaccine candidate, which may affect its development moving forward [51][54] Other Important Information - The company successfully completed debt refinancing, enhancing its financial flexibility [5] - Cash used in operating activities decreased significantly to EUR 28.4 million from EUR 76.7 million in the first nine months of 2024 [20] Q&A Session Summary Question: Timeline for FDA response regarding the chikungunya vaccine - Management indicated there is no predefined process for the FDA response and hopes for collaborative interaction, but no specific timeline can be provided [29] Question: Impact of currency and distributor shift on Ducoral sales - Management acknowledged currency impacts and noted a technical delay in sales due to the transition to a new distributor in Germany, expecting continued growth for Ducoral [30][31] Question: Timing of Lyme phase 3 readout and potential delays - Management stated that Pfizer controls the process and is taking steps to ensure timely results, with no major delays anticipated [36][37] Question: Proposed remedies for the exchange BLA suspension - The response to the FDA focused on medical evidence and positive risk-benefit ratios, with ongoing pharmacovigilance reviews [40] Question: Launch timeline for VLA15 and IXIARO growth drivers - Management confirmed timelines for VLA15 support a launch in late 2027, while IXIARO's growth is expected to continue through expansion in endemic regions and travel markets [45][46] Question: Funding considerations for the Zika vaccine candidate - Management highlighted uncertainty around funding and regulatory pathways, indicating that substantial funding would be necessary to proceed with development [53][54]
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
Core Viewpoint - The company has initiated Phase I clinical trials for its inhaled tuberculosis vaccine in Indonesia, marking a significant step in its development process [1] Group 1: Clinical Trial Details - The Phase I clinical trial aims to explore the safety and immunogenicity of a single dose of the inhaled tuberculosis vaccine in adults aged 18-49 [1] - The first subject has been enrolled in the Phase I clinical trial in Indonesia [1] Group 2: Vaccine Background - Currently, the BCG vaccine is the only vaccine available globally for tuberculosis prevention, widely administered and crucial for preventing tuberculosis in infants [1] - The effectiveness of the BCG vaccine diminishes over time, and it cannot be enhanced through booster vaccinations [1] - The company has developed a first-generation innovative tuberculosis booster vaccine for individuals who have received the BCG vaccine, which has completed Phase Ia and Ib clinical trials in Canada [1] Group 3: Clinical Data and Efficacy - Clinical data from the trials in Canada have demonstrated the safety of the candidate vaccine and its effectiveness as a booster for the BCG vaccine, highlighting its superiority in mucosal immunity [1]
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]