Core Viewpoint - Zhonghui Biotech-B (02627) saw a stock increase of over 5%, currently trading at HKD 42.68 with a transaction volume of HKD 8.3148 million, following the announcement of the initiation of Phase I clinical trials for its quadrivalent and trivalent influenza virus subunit vaccines [1] Group 1: Clinical Trials and Approvals - The company has recently launched Phase I clinical trials for its quadrivalent influenza virus subunit vaccine (adjuvanted) and trivalent influenza virus subunit vaccine (adjuvanted) [1] - The quadrivalent influenza virus subunit vaccine (adjuvanted) received approval from the National Medical Products Administration of the People's Republic of China for clinical trial application in July 2024, while the trivalent version is set for approval in October 2024 [1] Group 2: Target Demographic and Vaccine Design - The vaccines are specifically designed for individuals aged 65 and above, as this demographic experiences a natural decline in immune function with age, making them more susceptible to severe illness and death from influenza [1] - The inclusion of the MF59-like adjuvant enhances immune response and increases antibody titers, providing better protection for the elderly population [1]

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 - Zhonghui Biotech-B (02627) has initiated Phase I clinical trials for its quadrivalent and trivalent influenza virus subunit vaccines, specifically designed for individuals aged 65 and above, addressing the increased health risks associated with influenza in this demographic [1] Group 1: Clinical Trials - The company has received approval from the National Medical Products Administration of the People's Republic of China for the clinical trial applications of the quadrivalent influenza virus subunit vaccine in July 2024 and the trivalent influenza virus subunit vaccine in October 2024 [1] Group 2: Target Demographic - The vaccines are specifically designed for the elderly population, particularly those aged 65 and older, who are at a higher risk of severe illness and death from influenza due to natural declines in immune function with age [1] Group 3: Vaccine Features - The quadrivalent and trivalent influenza virus subunit vaccines are enhanced with an MF59-like adjuvant, which boosts immune response and increases antibody titers, providing better protection for the targeted age group [1]

Core Viewpoint - The company has initiated Phase I clinical trials for its quadrivalent and trivalent influenza virus subunit vaccines, specifically designed for individuals aged 65 and older, to enhance immune response and provide better protection against influenza [1] Group 1: Clinical Trials - The company has started Phase I clinical trials for its quadrivalent influenza virus subunit vaccine (adjuvanted) and trivalent influenza virus subunit vaccine (adjuvanted) [1] - The quadrivalent influenza virus subunit vaccine (adjuvanted) received approval for clinical trial application from the National Medical Products Administration of the People's Republic of China in July 2024 [1] - The trivalent influenza virus subunit vaccine (adjuvanted) obtained similar approval in October 2024 [1] Group 2: Target Population - The vaccines are specifically designed for the elderly population, particularly those aged 65 and above, who are at a higher risk of severe illness and death from influenza due to natural decline in immune function with age [1] - This demographic faces increased health impacts and economic burdens due to influenza infections [1] Group 3: Vaccine Features - The quadrivalent and trivalent vaccines include the MF59 adjuvant, which enhances immune response and increases antibody titers, providing better protection for the targeted age group [1]

Core Viewpoint - Changchun High-tech announced that its subsidiary, Baike Biotech, received the Clinical Trial Approval Notice from the National Medical Products Administration for its trivalent influenza virus split vaccine, allowing clinical trials to prevent influenza caused by related strains of the virus [1] Group 1 - The vaccine is targeted at individuals aged 60 and above [1] - The vaccine utilizes a split virus technology route and is combined with a self-developed adjuvant to ensure safety while enhancing immunogenicity [1] - Successful completion of clinical trials and subsequent approval for market launch will further enhance the company's influenza vaccine research pipeline and expand its coverage among the population [1]

格隆汇10月13日丨百克生物(688276.SH)公布，公司近日收到国家药品监督管理局下发的三价流感病毒 裂解疫苗（BK-01佐剂）的《药物临床试验批准通知书》。为此，公司自主研发了本次获批临床的三价 流感病毒裂解疫苗（BK-01佐剂），该疫苗接种对象为60岁及以上人群，接种后可刺激机体产生更强的 免疫应答。该疫苗采用流感病毒裂解疫苗工艺技术路线，配伍以公司自主研发的佐剂，保证疫苗安全性 的同时提高了疫苗的免疫原性，与传统裂解流感疫苗相比，可激发机体产生更高水平的保护性抗体，为 老年人群提供有效的防护。 若该疫苗品种顺利完成临床试验，并获批上市，将进一步完善公司流感疫苗研发管线，为60岁及以上人 群提供新的接种选择，扩大公司流感疫苗的人群覆盖范围。也将助力公司优化产品结构和主营业务的全 面发展，增强公司长期盈利能力。 ...

Core Insights - Cidara Therapeutics, Inc. (CDTX) stock surged over 90% following the release of positive topline results from its Phase 2b NAVIGATE trial for CD388, aimed at preventing seasonal influenza in healthy unvaccinated adults aged 18 to 64 [1][6] Study Results - The NAVIGATE trial met its primary endpoint, showing statistically significant prevention efficacy (PE) across all three dose groups, with evaluations conducted over 24 weeks [2] - The highest dose group (450 mg) achieved a 76.1% prevention efficacy, while the 300 mg and 150 mg doses demonstrated 61.3% and 57.7% efficacy, respectively, all statistically significant compared to placebo [3] - Secondary endpoints were also met, including efficacy at specific temperature thresholds and maintenance of PE for up to 28 weeks [2] Safety and Tolerability - CD388 was well-tolerated across all doses, with no unexpected dose-limiting treatment-emergent adverse events reported [3][4] - No serious drug-related adverse events were observed, and injection site reaction rates were consistent across all dose groups [4] Regulatory Actions - Cidara has submitted a request to the FDA for an end of Phase 2 meeting to discuss the results and the design of the upcoming Phase 3 trial [5]