人民财讯1月13日电，博晖创新（300318）1月13日公告，近日，公司控股孙公司博晖生物制药股份有限 公司与北京百晖生物科技有限公司联合申报的冻干人用狂犬病疫苗(人二倍体细胞)，获得国家药监局出 具的《药物临床试验批准通知书》，同意开展临床试验。 ...

打狂犬疫苗被医院私自更换药品？贵州桐梓县卫健局通报 剂/X,12月17日10时14分技秤表果、10时18分 接种成某某共2剂次,17日库存65剂次;成都康 华生物制品股份有限公司生产的冻干人用狂犬病 疫苗12月16日库存9剂次,17日14时48分接种 赵某某1剂次,17日库存8剂次。海校街道社区 卫生服务中心不存在更换药品情况。赵某某实际 注射疫苗为成都康华生物制品股份有限公司生产 的冻干人用狂犬病疫苗(人二倍体细胞),价格 310元/剂次。 二、处理情况 事情发生后,海校街道社区卫生服务中心主任马 某因护士扫错码一事,主动向赵某某家属诚恳道 歉。根据调查情况,我局对海校街道社区卫生服 务中心主任马某、副主任刘某通报批评,分别惩 扣1个月绩效工资,对当班护士冯某、令狐某分 别给予批评教育、惩扣3个月绩效工资。 下一步,我局将举一反三,从严规范全县医疗机 构内部管理。感谢社会各界的关心与监督! 桐梓县卫生健康局 2025年12月20日 ...

Core Viewpoint - The article discusses the significant changes in the governance and operational challenges faced by Kanghua Biological (300841.SZ) following its change of control, highlighting a sharp decline in its core product's market performance and the pressures from performance commitments [2][4][10]. Group 1: Change of Control and Shareholder Actions - Kanghua Biological has undergone a change of control with major shareholders reducing their stakes during the transition period, leading to the company entering a state without a controlling shareholder [3][4]. - The fourth largest shareholder, Sichuan Development Securities Investment Fund Management Co., Ltd., reduced its stake from 6.22% to 5.91%, cashing out approximately 32.66 million yuan [3]. - The transfer of control involved the original controlling shareholder, Wang Zhentao, transferring 21.91% of shares to Wanke Xin Biological for a total consideration of 1.851 billion yuan [4]. Group 2: Board Restructuring and Management Changes - Following the change of control, Kanghua Biological completed a full overhaul of its board and executive team, with the new board consisting of 11 members, including 7 non-independent and 4 independent directors [5][7]. - Liu Dawei was elected as the new chairman, while Wang Zhentao became the vice chairman and legal representative [5][6]. Group 3: Financial Performance and Challenges - Kanghua Biological reported a significant decline in financial performance for the first three quarters of 2025, with revenue dropping by 20.78% to 840 million yuan and net profit decreasing by 53.41% to 189 million yuan [8]. - The company's core product, the freeze-dried human rabies vaccine, saw a drastic reduction in batch issuance by over 40%, primarily due to increased competition in the market [9]. - The company faces a performance commitment to achieve a net profit of at least 728 million yuan over 2025 and 2026, alongside a minimum of 260 million yuan in R&D expenses, which poses a significant challenge given its current performance pressures [10][11].

Core Viewpoint - The company Zhonghui Biotech-B (02627) has initiated Phase III clinical trials for its lyophilized rabies vaccine (human diploid cells) aimed at three immunization regimens, marking a significant step in its vaccine development process [1] Group 1: Clinical Trial Progress - The company received approval from the National Medical Products Administration of the People's Republic of China for new drug clinical trials for the Essen (five-dose) regimen in November 2022 [1] - In April 2023, the company obtained approval for supplementary clinical trial applications for the Zagreb (four-dose) and simplified four-dose regimens [1] - The company completed Phase I clinical trials for the rabies vaccine in October 2024 [1] Group 2: Vaccine Characteristics - Rabies is a severe viral disease caused by the rabies virus, leading to serious symptoms such as confusion and progressive paralysis, which are almost always fatal once symptoms appear [1] - Immediate vaccination after exposure to the virus can prevent rabies [1] - The rabies vaccine developed using human diploid cells is recognized as the "gold standard" rabies vaccine by the World Health Organization, demonstrating strong safety profiles [1] - The rabies vaccine has shown good safety characteristics in the completed Phase I clinical trials [1]

近日，中慧生物(02627)自主研发的冻干人用狂犬病疫苗(人二倍体细胞)Ⅲ期临床试验启动会，在湖北研 究现场顺利召开。这标志着该核心产品向成功上市迈出了关键一步。 狂犬病是由狂犬病病毒(RABV)引起的一种人和动物共患的急性传染病，地理分布广泛，世界上约有150 多个国家和地区均有狂犬病发生。人与动物一旦发病，几乎100%死亡，给人类生命安全带来巨大威 胁。狂犬病的发病时间及病毒侵入部位与病毒移动至中枢神经系统的速度相关，一般为感染后20～60d 或更长或更短。狂犬病表现为急性脑脊髓炎，临床上会有恐水、怕风、吞咽困难等中枢神经系统受损症 状，紧接着会出现呼吸功能和循环功能丧失而死亡。 目前，狂犬病尚无有效治疗手段，预防至关重要，其中疫苗接种是最为有效的防控措施。人二倍体细胞 狂犬病疫苗(HDCV)在欧洲及北美已有40余年应用历史，其安全性与有效性已得到充分验证，被国际公 认为狂犬病疫苗的"金标准"，也常作为新研发疫苗的对照基准。该研究涉及的冻干人用狂犬病疫苗(人 二倍体细胞)已完成Ⅰ期临床试验，结果显示，无论是采用Essen程序还是Zagreb程序接种于10-60岁人 群，该疫苗均表现出良好的安全性。 关于冻 ...

智通财经APP获悉，近日，中慧生物(02627)自主研发的冻干人用狂犬病疫苗(人二倍体细胞)Ⅲ期临床试 验启动会，在湖北研究现场顺利召开。这标志着该核心产品向成功上市迈出了关键一步。 关于冻干人用狂犬病疫苗(人二倍体细胞) 狂犬病是由狂犬病病毒(RABV)引起的一种人和动物共患的急性传染病，地理分布广泛，世界上约有150 多个国家和地区均有狂犬病发生。人与动物一旦发病，几乎100%死亡，给人类生命安全带来巨大威 胁。狂犬病的发病时间及病毒侵入部位与病毒移动至中枢神经系统的速度相关，一般为感染后20～60d 或更长或更短。狂犬病表现为急性脑脊髓炎，临床上会有恐水、怕风、吞咽困难等中枢神经系统受损症 状，紧接着会出现呼吸功能和循环功能丧失而死亡。 目前，狂犬病尚无有效治疗手段，预防至关重要，其中疫苗接种是最为有效的防控措施。人二倍体细胞 狂犬病疫苗(HDCV)在欧洲及北美已有40余年应用历史，其安全性与有效性已得到充分验证，被国际公 认为狂犬病疫苗的"金标准"，也常作为新研发疫苗的对照基准。该研究涉及的冻干人用狂犬病疫苗(人 二倍体细胞)已完成Ⅰ期临床试验，结果显示，无论是采用Essen程序还是Zagreb程序接 ...

狂犬病是由一种狂犬病病毒引起的严重病毒性疾病，可能导致意识模糊和渐进性瘫痪等严重症状。一旦 出现症状，几乎总是致命的，但接触病毒后立即接种适当的疫苗可以预防狂犬病。利用人二倍体细胞研 制的狂犬病疫苗为世卫组织推荐的"金标准"狂犬病疫苗，具有强大的安全性。公司的在研狂犬病疫苗在 已完成的I期临床试验中显示出良好的安全性特征。 智通财经APP讯，中慧生物-B(02627)发布公告，集团近期启动集团冻干人用狂犬病疫苗(人二倍体细胞) 的III期临床试验。针对开发用于三种免疫方案的在研疫苗，公司于2022年11月就Essen(五针)方案获得中 华人民共和国国家药品监督管理局核准的新药临床试验许可，并于2023年4月获批Zagreb(四针)和简易四 针方案的补充临床试验申请。公司于2024年10月完成该在研疫苗的I期临床试验。 ...

Core Viewpoint - Jiangsu Zhonghui Yuantong Biotechnology Co., Ltd. and its subsidiary Yihui Biotechnology (Shanghai) Co., Ltd. have successfully initiated Phase I clinical trials for their adjuvanted influenza virus subunit vaccines in Hubei province [1][4]. Group 1: Vaccine Development - The adjuvanted influenza virus subunit vaccine is designed to meet the vaccination needs of different populations, particularly targeting individuals aged 65 and above [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, for a total of one dose on day 0 [4]. - Preclinical studies indicate that the adjuvanted vaccine significantly enhances antibody levels and neutralizing antibody titers, providing a superior immune response for the elderly [4]. Group 2: Public Health Context - Influenza poses a significant public health burden, with the WHO estimating 3 to 5 million severe cases globally each year [3]. - In China, the average annual excess mortality due to respiratory diseases caused by influenza was approximately 88,000 from 2010 to 2015, highlighting the need for effective vaccination strategies [3]. - The overall vaccination rate for influenza in China remains low, with only 3.84% during the 2022-2023 flu season, indicating a critical gap in immunity [3]. Group 3: Company Overview - Zhonghui Biotechnology focuses on the research, development, manufacturing, and commercialization of innovative vaccines and traditional vaccines using new technologies [5]. - The company has made significant investments in R&D, with approved clinical products including recombinant zoster vaccine and adjuvanted influenza virus subunit vaccine [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 vaccines [6].

Core Viewpoint - Fosun Pharma (600196)(02196) announced the board's decision to plan for the spin-off listing of its subsidiary, Fosun Antigen (Chengdu) Biopharmaceutical Co., Ltd. on the Hong Kong Stock Exchange [1] Group 1: Company Overview - Fosun Antigen was established in July 2012 and is primarily focused on the research, production, and sales of human vaccines [1] - As of the announcement date, Shanghai Fosun Pharma Industry Development Co., Ltd. holds a 70.08% stake in Fosun Antigen, while 17 other shareholders own the remaining 29.92% [1] Group 2: Product Development - Fosun Antigen has developed a technical platform for both bacterial and viral vaccines [1] - The company has received approval for several self-developed human vaccines in mainland China, including rabies vaccines (Vero cell), lyophilized rabies vaccines (Vero cell), trivalent influenza virus split vaccine, and quadrivalent influenza virus split vaccine [1] - The 13-valent pneumococcal conjugate vaccine is currently in Phase III clinical trials, while the lyophilized rabies vaccine (human diploid cells) and 24-valent pneumococcal polysaccharide vaccine are in Phase I clinical trials [1] - The 23-valent pneumococcal polysaccharide vaccine has received approval for clinical trials [1]

Core Viewpoint - Kanghua Biotech (300841.SZ) demonstrates resilience and growth potential with a 11.54% year-on-year revenue increase in Q3 2025, achieving revenue of 356 million yuan and a net profit of 189 million yuan for the first three quarters [1] Group 1: Financial Performance - In Q3 2025, Kanghua Biotech reported revenue of 356 million yuan, marking an 11.54% increase compared to the same period last year [1] - For the first three quarters, the company achieved total revenue of 840 million yuan and a net profit attributable to shareholders of 189 million yuan [1] - The decline in net profit for the first three quarters narrowed by 9.23 percentage points compared to the semi-annual report, indicating improved operational quality [1] Group 2: Product Development and Market Potential - The freeze-dried human rabies vaccine (human diploid cells) is a key product for Kanghua Biotech, recognized as the "gold standard" by WHO due to its safety and efficacy [2] - The company is expanding production capacity for the rabies vaccine, with the production expansion project nearing completion and awaiting drug production license approval [2] - Kanghua Biotech's six-valent norovirus vaccine, licensed to HilleVax for $270.5 million, showcases the company's strong technical capabilities and market potential [2] Group 3: Industry Context and Future Prospects - Norovirus is a major cause of acute gastroenteritis globally, with no vaccines currently available, presenting a significant market opportunity as the norovirus vaccine market in China is projected to grow from 1.53 billion yuan to 22.93 billion yuan from 2026 to 2031, with a CAGR of 71.85% [3] - The six-valent norovirus vaccine has received clinical research approval in Australia and the U.S., with plans for clinical trials in China starting in December 2024 [4] Group 4: Strategic Developments - The transition of control to a state-owned investment fund from Shanghai is expected to provide Kanghua Biotech with not only capital but also a robust industrial resource network and strategic development platform [5][6] - The investment from the Shanghai biopharmaceutical fund highlights Kanghua Biotech's long-term intrinsic value amid the industry's adjustment phase [5] - The company aims to accelerate the diversification of its vaccine product line, potentially becoming a key platform for the Shanghai pharmaceutical industry in the vaccine sector [7]