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]

致：香港交易及結算所有限公司 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年10月31日 狀態: 新提交 公司名稱: 江蘇中慧元通生物科技股份有限公司 呈交日期: 2025年11月4日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02627 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 296,361,845 | RMB | | 1 RMB | | 296,361,845 | | 增加 / 減少 (-) | | | 0 | | | RMB | | 0 | | 本月底結存 | | | 296,361,845 | RMB | | 1 RMB | | 296,361,845 | | 2. 股份分類 | 普通股 | 股份類別 | 其 ...

今年秋冬，亚太地区的流感疫情比往年来得更早、更猛：在日本，流感季较去年提前了5周到来，10月6 日至12日期间全国共报告流感病例超9000例，报告病例数达去年同期的2.65倍，每周新增病例数已连续 8周增加;同期，我国南方省份哨点医院报告的流感样病例百分比为4.1%，也显著高于2022年和2024年同 期水平。 报道显示，本次流感流行的毒株以甲型H3N2为主，其抗原漂移变异导致既往疫苗保护效力下降，且对 儿童、老年人等高危群体的致病性更强，易引发高热、肺炎等重症，给今冬的呼吸道传染病防控带来更 大压力。 在此背景下，我国首款适用于6月龄以上全人群的四价流感病毒亚单位疫苗——慧尔康欣(HRK-X®)的 扩龄上市，可谓恰逢其时。该款疫苗将适用年龄扩大至6月龄及以上全人群，这意味着婴幼儿和老年人 等流感高危人群都可接种该款疫苗，获得与成人同等技术标准的高品质疫苗保护。 安全性优势显著，切入婴幼儿高端市场空白 智通财经APP了解到，目前我国使用的流感疫苗主要分为裂解疫苗、亚单位疫苗和鼻喷减毒活疫苗三 类。其中，慧尔康欣所采用的亚单位工艺，代表了一条更注重安全性与纯度的技术路径。 与传统的裂解疫苗和减毒活疫苗相比，慧尔 ...

报道显示，本次流感流行的毒株以甲型H3N2为主，其抗原漂移变异导致既往疫苗保护效力下降，且对 儿童、老年人等高危群体的致病性更强，易引发高热、肺炎等重症，给今冬的呼吸道传染病防控带来更 大压力。 在此背景下，我国首款适用于6月龄以上全人群的四价流感病毒亚单位疫苗——慧尔康欣(HRK-X)的扩 龄上市，可谓恰逢其时。该款疫苗将适用年龄扩大至6月龄及以上全人群，这意味着婴幼儿和老年人等 流感高危人群都可接种该款疫苗，获得与成人同等技术标准的高品质疫苗保护。 安全性优势显著，切入婴幼儿高端市场空白 智通财经APP了解到，目前我国使用的流感疫苗主要分为裂解疫苗、亚单位疫苗和鼻喷减毒活疫苗三 类。其中，慧尔康欣所采用的亚单位工艺，代表了一条更注重安全性与纯度的技术路径。 与传统的裂解疫苗和减毒活疫苗相比，慧尔康欣HRK-X四价流感亚单位疫苗通过精准纯化工艺，去除 了病毒内部蛋白和膜蛋白等杂质，约5支裂解疫苗的原材料能萃取生成1支亚单位疫苗，显著提高了疫苗 纯度。这一技术突破使其不良反应更少、免疫原性更强，尤其适合儿童、老年人及免疫力较弱人群。 国际疫苗学期刊《疫苗》刊载的数据显示，这款四价流感亚单位疫苗在3-8岁儿童中 ...

Major Events - Meili Tianyuan Medical Health (02373) acquires 100% of Shanghai Siyuanli Industrial for 1.25 billion yuan, aiming to capture the high-end beauty market in major cities [1] - Jinhai Medical Technology (02225) is actively preparing to participate in the 8th China International Import Expo [1] - China Biopharmaceutical (01177) has its selective MEK1/2 inhibitor TQ-B3234 included in the breakthrough therapy designation program [1] - Beijing Jiakesi plans to sell 90% of Jiakexi Health through capital increase and equity transfer agreements [1] - Green Power Environmental (01330) intends to invest in establishing a joint venture in Hong Kong to expand overseas environmental business [1] - Zhonghui Biotechnology (02627) applies for full circulation of H-shares [1] Operating Performance - Legend Holdings (03396) reports that its subsidiary, Legend New Science (003022.SZ), achieved a net profit attributable to shareholders of 232 million yuan in the first three quarters, an increase of 30.32% [1] - Mongol Mining (00975) reports total raw coal production of 3.6043 million tons from UHG and BN mines in the third quarter [1] - China Resources Power (00836) reports cumulative electricity sales of 161 million megawatt-hours from its subsidiary power plants in the first nine months, a year-on-year increase of 4.2% [1] - China Coal Energy (01898) reports coal sales of 19.66 million tons in September, a year-on-year decrease of 20.1% [1] - Air China (00753) reports a 1.2% year-on-year increase in passenger capacity input and a 5.6% year-on-year increase in passenger turnover in September [1]

Core Viewpoint - Zhonghui Biotech-B (02627) has submitted an application to the China Securities Regulatory Commission for the conversion of 81.662 million unlisted shares into H-shares and for the listing of these shares on the Hong Kong Stock Exchange [1] Group 1 - The company plans to convert a total of 81.662 million unlisted shares into H-shares [1] - The application for the conversion and listing has been submitted to the China Securities Regulatory Commission [1] - The listing is intended to take place on October 15, 2025 [1]

Core Viewpoint - Zhonghui Biotech-B (02627) has submitted an application to the China Securities Regulatory Commission for the conversion of 81.662 million unlisted shares into H-shares and their listing on the Hong Kong Stock Exchange, scheduled for October 15, 2025 [1] Group 1 - The company plans to convert 81.662 million unlisted shares into H-shares [1] - The application for the conversion and listing has been submitted to the China Securities Regulatory Commission [1] - The expected date for the listing on the Hong Kong Stock Exchange is October 15, 2025 [1]

Group 1 - The company Zhonghui Biotech-B (02627.HK) announced that it has submitted an application to the China Securities Regulatory Commission for the conversion of 81,661,895 unlisted shares into H-shares [1] - The conversion aims for the listing of these shares on the Hong Kong Stock Exchange, facilitating full circulation of H-shares [1] - The expected date for this conversion and listing is October 15, 2025 [1]