Core Viewpoint - Zhonghui Biotech-B (02627.HK) has received approval for its IND application for a recombinant respiratory syncytial virus (RSV) vaccine from both the National Medical Products Administration (NMPA) in China and the U.S. Food and Drug Administration (FDA) [1][2] Group 1: Vaccine Development - The RSV vaccine is developed using CHO cells and expresses a modified pre-F protein, showing higher expression levels compared to existing marketed RSV vaccines [1][2] - The pre-F protein expression from the company's high-yield cell line ranges from approximately 1,000 mg/L to 1,500 mg/L, significantly higher than the 600 mg/L to 800 mg/L range of currently available products [2] - The vaccine demonstrates superior thermal stability, maintaining over 95% activity after 14 days at 40°C, while existing products drop to around 50% activity [2] Group 2: Clinical Research and Safety - Preclinical studies indicate that the vaccine has better immunogenicity, with significantly higher geometric mean titers of neutralizing antibodies compared to marketed counterparts [2] - The vaccine has shown good safety profiles in toxicity studies and active systemic allergic reaction tests [2]

Core Viewpoint - The company has received approval for its self-developed recombinant respiratory syncytial virus (RSV) vaccine from both the National Medical Products Administration (NMPA) in China and the U.S. Food and Drug Administration (FDA) [1][2] Group 1: Vaccine Development - The recombinant RSV vaccine is developed using CHO cells and expresses modified pre-F protein, demonstrating higher expression levels compared to existing vaccines [2] - The pre-F protein expression levels for the company's high-yield cell line range from approximately 1,000 mg/L to 1,500 mg/L, significantly higher than the 600 mg/L to 800 mg/L of currently marketed products [2] - The vaccine shows excellent thermal stability, maintaining over 95% activity after 14 days at 40°C, while existing products drop to around 50% activity [2] Group 2: Clinical and Safety Profile - Preclinical studies indicate that the vaccine has superior immunogenicity, with significantly higher geometric mean titers of neutralizing antibodies compared to similar marketed products [2] - The vaccine has demonstrated good safety profiles in toxicity studies and active systemic allergic reaction tests [2] Group 3: Market Context - RSV is a highly infectious RNA virus that poses significant health risks, particularly to infants, the elderly, and immunocompromised individuals, with a high incidence of acute respiratory infections [1] - The lack of effective therapeutic options for RSV has made vaccination a preferred clinical solution for prevention [1]

Group 1 - The company Zhonghui Biotech-B (02627) has received approval for its IND application for a recombinant respiratory syncytial virus (RSV) vaccine from both the National Medical Products Administration (NMPA) in China and the U.S. Food and Drug Administration (FDA) [1][2] - RSV is a highly infectious RNA virus that significantly impacts infants, the elderly, and immunocompromised individuals, being a leading cause of respiratory infections [1] - The vaccine is positioned as a preferred clinical solution for RSV prevention due to the lack of effective therapeutic drugs currently available [1] Group 2 - The vaccine utilizes CHO cells to express a modified pre-F protein, achieving higher expression levels compared to existing marketed RSV vaccines, with production levels between 1,000 mg/L and 1,500 mg/L, compared to 600 mg/L to 800 mg/L for current products [2] - The preclinical studies indicate that the vaccine maintains over 95% activity after 14 days at 40°C, while existing products show a reduction to around 50% [2] - The company's vaccine demonstrates superior immunogenicity in preclinical trials, with significantly higher neutralizing antibody geometric mean titers compared to marketed counterparts, alongside good safety profiles in toxicity studies [2]

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。 重組呼吸道合胞病毒疫苗（CHO細胞）（佐劑） 的IND獲中國CDE及美國FDA批准 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，本集團自主研發的重組呼吸道合 胞病毒疫苗（CHO細胞）（佐劑）的新藥臨床試驗（「IND」）申請已經獲得國家藥品 監督管理局藥品審評中心（「CDE」）批准。此外，該款疫苗在美國（「美國」）的IND 申請亦已獲得美國食品藥品監督管理局（「FDA」）的批准。 呼吸道合胞病毒（「RSV」）作為一種高傳染性RNA病毒，是導致嬰兒、老年人和 免疫功能不全 ...