智通财经APP在《国内首款全人群四价流感亚单位疫苗获批，中慧生物-B(02627)商业化放量在即》中指 出，作为国内预防用生物制品一类新药，四价流感病毒亚单位疫苗已于今年8月进入商业保险创新药目 录初步形式审查名单，且为名单中唯一入选的疫苗产品，稀缺性显著，预计上市后将有效填补相应市场 空白。 目前国内市场上主流产品为第二代普通裂解流感疫苗，而中慧生物-B开发的"亚单位"流感疫苗属于第三 代技术路线。其在裂解疫苗基础上进一步优化生产工艺，仅提取病毒表面有效抗原成分——血凝素 (HA)和神经氨酸酶(NA)，显著提高抗原纯度，降低杂质含量，在安全性、免疫效果和整体品质方面具 备明显优势。 中慧生物-B(02627)涨超8%，截至发稿，涨7.49%，报51.25港元，成交额1846.3万港元。 消息面上，近日，中慧生物-B发布公告，公司董事会欣然宣布，中国国家药品监督管理局(国家药监局) 已批准集团针对6-35月龄人群的四价流感病毒亚单位疫苗的新药申请。该款疫苗成为中国首款且唯一一 款获批上市的全人群全剂量四价流感病毒亚单位疫苗。该产品在传统病毒裂解疫苗的基础上进行重大升 级，具有保护全面、组分抗原纯度高、不良反应 ...

消息面上，近日，中慧生物-B发布公告，公司董事会欣然宣布，中国国家药品监督管理局(国家药监局) 已批准集团针对6-35月龄人群的四价流感病毒亚单位疫苗的新药申请。该款疫苗成为中国首款且唯一一 款获批上市的全人群全剂量四价流感病毒亚单位疫苗。该产品在传统病毒裂解疫苗的基础上进行重大升 级，具有保护全面、组分抗原纯度高、不良反应风险低等优势。 智通财经APP获悉，中慧生物-B(02627)涨超8%，截至发稿，涨7.49%，报51.25港元，成交额1846.3万港 元。 智通财经APP在《国内首款全人群四价流感亚单位疫苗获批，中慧生物-B(02627)商业化放量在即》中指 出，作为国内预防用生物制品一类新药，四价流感病毒亚单位疫苗已于今年8月进入商业保险创新药目 录初步形式审查名单，且为名单中唯一入选的疫苗产品，稀缺性显著，预计上市后将有效填补相应市场 空白。 目前国内市场上主流产品为第二代普通裂解流感疫苗，而中慧生物-B开发的"亚单位"流感疫苗属于第三 代技术路线。其在裂解疫苗基础上进一步优化生产工艺，仅提取病毒表面有效抗原成分——血凝素 (HA)和神经氨酸酶(NA)，显著提高抗原纯度，降低杂质含量，在安全性、免 ...

Core Viewpoint - Zhonghui Biotech-B (02627) has seen a stock price increase of over 3%, currently trading at 50.4 HKD with a transaction volume of 5.0766 million HKD, following the approval of its quadrivalent influenza virus subunit vaccine by the National Medical Products Administration of China [1][1][1] Group 1 - The company announced that its quadrivalent influenza virus subunit vaccine has received approval for the 6-35 month age group, making it the first and only vaccine of its kind approved for the entire population in China [1][1] - The new vaccine represents a significant upgrade over traditional virus split vaccines, offering comprehensive protection, high purity of antigen components, and lower risk of adverse reactions [1][1][1]

Core Viewpoint - The company has received approval from the National Medical Products Administration of China for its quadrivalent influenza virus subunit vaccine, making it the first and only approved vaccine of its kind for the entire population in China [1] Company Overview - The company is a vaccine manufacturer based in China, focusing on the research, development, manufacturing, and commercialization of innovative vaccines and traditional vaccines using new technologies [1] - The company aims to replace traditional and imported vaccines in China with high-quality vaccines and expand its competitive advantages to international markets [1] Product Details - The newly approved quadrivalent influenza virus subunit vaccine is designed for individuals aged 6 to 35 months and offers comprehensive protection, high purity of antigen components, and a low risk of adverse reactions [1] - The product represents a significant upgrade over traditional virus-inactivated vaccines [1] - The company's product pipeline includes the quadrivalent influenza virus subunit vaccine, a lyophilized human rabies vaccine under development, and other vaccines in the research phase [1]

Core Viewpoint - Zhonghui Biotech-B (02627) has received approval from the National Medical Products Administration of China for its quadrivalent influenza virus subunit vaccine aimed at the 6-35 month age group, marking it as the first and only approved vaccine of its kind in China for the entire population and all dosage levels [1] Company Overview - The company is headquartered in China and focuses on the research, development, manufacturing, and commercialization of innovative vaccines and traditional vaccines using new technological methods [1] - The company tracks global infectious disease incidence and vaccine development trends to determine its product pipeline, emphasizing high-quality vaccines to replace traditional and imported vaccines in China while expanding its competitive advantage to international markets [1] Product Details - The newly approved quadrivalent influenza virus subunit vaccine is a significant upgrade over traditional virus split vaccines, offering comprehensive protection, high purity of antigen components, and lower risk of adverse reactions [1] - The company's product line includes the quadrivalent influenza virus subunit vaccine, a lyophilized human rabies vaccine under development, and other vaccines in the pipeline [1]

Core Viewpoint - Zhonghui Biotech-B (02627.HK) has received approval from the National Medical Products Administration of China for its quadrivalent influenza virus subunit vaccine aimed at the population aged 6 to 35 months, marking it as the first and only approved vaccine of its kind in China for the entire population and all dosage levels [1] Group 1 - The vaccine represents a significant upgrade over traditional virus split vaccines, offering comprehensive protection, high purity of antigen components, and a lower risk of adverse reactions [1]

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。 （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 四價流感病毒亞單位疫苗的上市申請獲國家藥監局批准 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，中國國家藥品監督管理局（「國家 藥監局」）已批准本集團針對6-35月齡人群的四價流感病毒亞單位疫苗的新藥申 請。 截至本公告日期，該款疫苗成為中國首款且唯一一款獲批上市的全人群全劑量四 價流感病毒亞單位疫苗。該產品在傳統病毒裂解疫苗的基礎上進行重大升級，具 有保護全面、組分抗原純度高、不良反應風險低等優勢。 關於中慧生物 Ab&B Bio-Tech CO., LTD. JS 江蘇中慧元通生物科技股份有限公司 香港，2025年9月3日 於本公告日期，董事會成員包括 ...

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8月31日 狀態: 新提交 呈交日期: 2025年9月3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 | 其他類別 (請註明) | | | 於香港聯交所上市 (註1) | | 否 | | ...

Core Viewpoint - The article highlights the significant market interest and potential of Zhonghui Biotech, particularly its innovative vaccine products, amidst a competitive landscape in the biotech industry [3][5]. Group 1: Company Overview - Zhonghui Biotech-B (02627.HK) debuted on the Hong Kong stock market on August 11, 2025, with a first-day stock price surge of 158%, and by August 25, its cumulative stock price increase reached 307.8%, with a market capitalization exceeding HKD 20 billion [3]. - The company experienced overwhelming investor interest during its IPO, achieving over 4,000 times subscription and raising more than HKD 200 billion, making it the "super subscription king" in the Hong Kong biotech sector for the year [3][5]. - Founded in 2015 by An Youcai, Zhonghui Biotech focuses on innovative vaccine development, with its core products being a quadrivalent influenza virus subunit vaccine and an in-development lyophilized rabies vaccine [6][9]. Group 2: Product Details - The quadrivalent influenza virus subunit vaccine, named "Hui Er Kang Xin," received approval from the National Medical Products Administration (NMPA) in May 2023 and began commercialization in the third quarter of the same year [7][9]. - "Hui Er Kang Xin" is the only approved quadrivalent influenza virus subunit vaccine in China, targeting two types of influenza A viruses (H1N1 and H3N2) and two types of influenza B viruses [8][9]. - The vaccine is priced at RMB 319 per dose, significantly higher than many competing products priced under RMB 100, which poses a challenge for market penetration [17][21]. Group 3: Financial Performance - Zhonghui Biotech's sales revenue is projected to increase from RMB 52.2 million in 2023 to RMB 260 million in 2024, representing a nearly 400% growth [9][11]. - Despite the revenue growth, the company reported a net loss of RMB 4.25 billion in 2023, which is expected to narrow to RMB 2.59 billion in 2024 [9][11]. - The company has invested RMB 5.36 billion in R&D from 2023 to the first quarter of 2025, which is 1.7 times its total revenue during the same period [24][25]. Group 4: Market Challenges - The company faces intense competition, with other firms reducing their influenza vaccine prices, which could impact the market share of "Hui Er Kang Xin" [21][22]. - The World Health Organization (WHO) suggests that trivalent influenza vaccines may suffice for current vaccination needs, potentially threatening the market for quadrivalent vaccines [23]. - Zhonghui Biotech's pricing strategy may face further pressure as more quadrivalent vaccines enter the market, with 19 additional influenza vaccines currently in clinical development [22][29]. Group 5: Future Prospects - Zhonghui Biotech is expanding its product pipeline, with 11 vaccines in development, including mRNA vaccines and recombinant vaccines targeting various diseases [27][29]. - The company is also pursuing international market opportunities, having registered its products in Macau and initiated registration in the Philippines, with plans for further expansion into multiple countries [33][34]. - The overall human vaccine market in China is projected to grow from RMB 53.5 billion in 2019 to RMB 96.1 billion in 2024, with a compound annual growth rate of 12.4% [29][30].

Core Viewpoint - Jiangsu Zhonghui Yuantong Biotechnology Co., Ltd. (Zhonghui Bio) reported significant growth in its first interim performance announcement post-IPO, driven by the commercialization of its core product, the quadrivalent influenza virus subunit vaccine, Hui Er Kang Xin, which has shown remarkable commercial success and a reduction in losses compared to the previous year [1][2]. Financial Performance - The company achieved a revenue of 71.12 million yuan in the first half of the year, representing a year-on-year increase of 918.91% [1]. - Sales costs decreased by 18.3% year-on-year, leading to a gross margin increase to 85.5% [1]. - Losses narrowed by 22% year-on-year, indicating ongoing improvements in profitability [1]. Product Development and Market Penetration - The quadrivalent influenza virus subunit vaccine, Hui Er Kang Xin, is the first and only approved quadrivalent influenza subunit vaccine in China, with a 100% pass rate for batch release since its commercialization began in September 2023 [2]. - The product's market penetration has expanded to 30 provinces, with over 1,100 collaborations with district-level disease control centers [2]. - The company is advancing its full population coverage strategy, with plans for a vaccine targeting infants aged 6-35 months expected to receive approval by Q3 2025 [2]. Research and Development Pipeline - The company has a diverse pipeline of 11 vaccines, structured in a gradient development model from late-stage to preclinical [4]. - The rabies vaccine is in the final clinical stage, having completed Phase I trials with promising safety results [3]. - The company is also progressing in other high-demand areas, including the 23-valent pneumococcal polysaccharide vaccine and recombinant RSV vaccine, with various clinical trials underway [4]. Global Expansion Strategy - The company is building its international sales network, with plans to enter markets in Indonesia, Thailand, Uruguay, Canada, Singapore, Mexico, and Hong Kong by 2026 [5]. - In 2024, the company received registration in Macau and is progressing with registration in the Philippines [5]. - The company aims to leverage seasonal differences in flu outbreaks across regions to optimize production capacity [5]. Future Outlook - With the anticipated approval of the low-age indication for the influenza vaccine and the rabies vaccine entering Phase III clinical trials, the company is positioned to strengthen its competitive advantage in the high-growth vaccine sector [5].