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 - Zhonghui Biotech-B (02627) has seen 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 - 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 is expected to receive clinical trial approval from the National Medical Products Administration of the People's Republic of China in July 2024, while the trivalent version is anticipated to receive approval in October 2024 [1] - The vaccines are specifically designed for individuals aged 65 and above, addressing the increased risk of severe illness and death from influenza in this age group due to natural declines in immune function [1] Group 2 - The addition of the MF59-like adjuvant enhances immune response and increases antibody titers, providing better protection for the elderly population [1] - The impact of influenza on older adults significantly affects health and increases economic burden, highlighting the importance of these vaccines [1]

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]

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 - Zhonghui Biotech-B (02627.HK) 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 and economic burden 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 the addition of MF59 adjuvant, which boosts immune response and increases antibody titers, providing better protection for the targeted age group [1]

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 ...

Core Insights - Zhonghui Biotech-B (02627) has made significant progress with its core product, a quadrivalent influenza virus subunit vaccine, which has been included in the latest vaccination guidelines by the Chinese CDC [1][5] - The company is actively advancing a clinical study for pregnant women to expand the vaccine's applicability to this demographic and infants aged 0-6 months, indicating a potential breakthrough in product development [1][2] Group 1: Clinical Research and Market Opportunity - Pregnant women are identified as a high-risk group for influenza and related complications, with increased susceptibility and risks during pregnancy [2] - The lack of local clinical safety and efficacy data for influenza vaccines in pregnant women has resulted in low vaccination rates in China compared to Western countries [2][3] - If successful, Zhonghui Biotech's vaccine could become the first influenza vaccine specifically for pregnant women in China, filling a significant gap in local clinical data and enhancing influenza prevention for this group [3] Group 2: Product Innovation and Industry Position - Zhonghui Biotech's quadrivalent influenza virus subunit vaccine utilizes a unique process that extracts key effective antigens, achieving a purity of over 85%, which results in a milder immune response and lower incidence of adverse reactions [4] - The vaccine has been recommended for individuals aged 6 months and older in the latest Chinese CDC guidelines, establishing the company as a new industry benchmark [5] - The vaccine is the only one to pass preliminary review for inclusion in the national basic medical insurance directory, which may alleviate payment pressures for innovative vaccines and enhance market accessibility [6]

Core Insights - Zhonghui Biotech-B (02627) has made significant progress with its core product, a quadrivalent influenza virus subunit vaccine, which has been included in the latest vaccination guidelines by the Chinese CDC [1][4] - The company is actively advancing a clinical study for pregnant women to expand the vaccine's applicability to this demographic and infants aged 0-6 months, marking a new phase of product development [1][2] Group 1: Clinical Research and Market Opportunity - Pregnant women are identified as a high-risk group for influenza and related complications, with increased susceptibility and risks during pregnancy [2] - The lack of local clinical safety and efficacy data for influenza vaccines in pregnant women has led to low vaccination rates in China compared to Western countries [2][3] - If successful, Zhonghui Biotech's vaccine could become the first influenza vaccine specifically for pregnant women in China, filling a significant gap in local clinical data and enhancing influenza prevention for this group [3] Group 2: Product Innovation and Industry Position - Zhonghui Biotech's quadrivalent influenza virus subunit vaccine utilizes a unique process that extracts key effective antigens, achieving over 85% purity, resulting in a safer and more effective vaccine [4] - The vaccine has been recommended for individuals aged 6 months and older in the latest Chinese CDC guidelines, establishing Zhonghui Biotech as a leader in setting industry standards [4] - The vaccine has also passed preliminary reviews for inclusion in national basic medical insurance and commercial insurance innovation drug directories, potentially easing the financial burden of high-priced innovative vaccines [5] Group 3: Competitive Landscape - The domestic influenza vaccine market is competitive, with several companies like Hualan Biological Engineering and HaiCheng Pharmaceutical also involved [4] - Zhonghui Biotech's "Hui Er Kang Xin" stands out as the first quadrivalent subunit influenza vaccine for the entire population, facing relatively less competitive pressure [4][5] - The company's innovative vaccine is positioned to replace traditional split vaccines, providing a clear long-term growth trajectory due to its unique value proposition [5]