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].

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® [1] 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, while gross margin improved to 85.5% [1] - Losses narrowed by 22% compared to the previous year, indicating ongoing improvement 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% batch release qualification rate since its commercialization began in September 2023 [2] - The product's market coverage has expanded to 30 provinces, with over 1,100 county-level CDC collaborations, enhancing market penetration [2] - The vaccine's strategy for full population coverage has made significant progress, with an application for infants aged 6-35 months expected to be approved by Q3 2025 [2] Research and Development Pipeline - The lyophilized human rabies vaccine has entered the final clinical stage, showing good safety characteristics in Phase I trials [3] - The company has a diversified pipeline of 11 vaccines, with multiple key milestones expected between 2025 and 2026 [4] - The 23-valent pneumococcal polysaccharide vaccine has entered Phase III clinical sample preparation, while the recombinant shingles vaccine has commenced Phase II trials [4] Global Expansion Strategy - The company is building a global sales network, with plans to enter markets in Indonesia, Thailand, and Uruguay by 2025, and expand to Canada, Singapore, Mexico, and Hong Kong by 2026 [5] - The company has received registration certificates in Macau and is progressing smoothly with registration in the Philippines [5] - The R&D team is well-supported, with a significant portion of staff holding advanced degrees, ensuring robust pipeline advancement [5]

Group 1: Market Overview - The market is experiencing increased expectations for a Federal Reserve interest rate cut in September, which is likely to attract more global capital into the Hong Kong pharmaceutical sector, particularly as valuations are being revised upward [1] - Recent updates in domestic pharmaceutical policies signal an optimization of the payment system, which is expected to further unlock the commercial potential of quality pharmaceutical companies [1] - The valuation recovery of the Hong Kong pharmaceutical sector is anticipated to be a strong and long-term process due to multiple favorable catalysts [1] Group 2: Company Performance - Zhonghui Biopharma-B (02627) has established a comprehensive structure integrating research, production, and sales, along with international development capabilities, which has garnered significant market attention [1] - The company’s stock price surged nearly 170% on its debut on August 11, 2023, setting a record for the highest first-day gain for a Hong Kong IPO in 2025, with a market capitalization exceeding HKD 20 billion within half a month [1] - Zhonghui Biopharma reported a revenue increase of over 900% year-on-year for the first half of 2025, indicating substantial growth potential for its stock price and market capitalization [1][2] Group 3: Product Development - The company’s core product, the quadrivalent influenza virus subunit vaccine, Hui Er Kang Xin, has shown significant clinical value and market acceptance, with a reported revenue of CNY 71.12 million for the first half of 2025, a year-on-year increase of 919.25% [2][3] - Hui Er Kang Xin is the first and only approved quadrivalent influenza vaccine in China, demonstrating high purity and low adverse reaction risks, with seroprotection rates exceeding EU standards [3] - The company is also developing a freeze-dried rabies vaccine using human diploid cells, which is expected to be a safer alternative to traditional vaccines, with Phase I clinical trials completed and Phase III trials planned for Q3 2025 [4] Group 4: Research and Development - Zhonghui Biopharma has invested CNY 98.84 million in R&D in the first half of the year, supporting its innovative product pipeline, which includes 11 other vaccines targeting various diseases [6] - The company has received IND approval for a recombinant respiratory syncytial virus vaccine, marking a significant milestone in its R&D efforts [7] - The vaccine's pre-F antigen structure offers excellent thermal stability, enhancing its commercial viability and potential market returns [7] Group 5: Production and Market Expansion - The company is actively enhancing its production capacity, with a facility in Jiangsu Taizhou covering over 48,000 square meters and equipped with multiple GMP-compliant production lines [8] - Hui Er Kang Xin has been approved for use in over 30 provinces in China, with a 100% product qualification and approval rate [8] - The company is pursuing international market registrations and plans to submit applications in several countries, including Thailand and Canada, to establish a global sales network [8][9] Group 6: Strategic Opportunities - Zhonghui Biopharma is exploring strategic acquisition opportunities, with over 10% of its IPO funds allocated for horizontal integration [9] - The company’s impressive revenue growth of over 900% in the first half of the year indicates a maturing model for innovative vaccine development and commercialization [9] - The integration of its R&D, production, and sales capabilities is expected to drive the intrinsic value of Zhonghui Biopharma continuously [9]

Core Viewpoint - The market's expectation for the Federal Reserve to lower interest rates in September is increasing, which is likely to attract more global capital into the Hong Kong pharmaceutical sector, particularly benefiting companies like Zhonghui Biopharma [1] Company Performance - Zhonghui Biopharma reported a revenue of 71.12 million yuan for the first half of 2025, representing a significant year-on-year increase of 919.25%, indicating strong market recognition of its core product, the Huili Kangxin® vaccine [2] - In contrast, competitors such as Wantai Biologics and Kanglaite reported declines in revenue and net profit, highlighting Zhonghui's strong performance amidst a challenging industry environment [2] Product Innovation - Huili Kangxin® is the first and only approved quadrivalent influenza virus subunit vaccine in China, showing high purity and low adverse reaction risks, with seroprotection rates exceeding EU standards [3] - The vaccine has demonstrated strong immune response capabilities, with seroprotection rates against various virus strains ranging from 89.41% to 97.98% [3] Research and Development - Zhonghui Biopharma has invested 98.84 million yuan in R&D in the first half of the year, supporting its innovative vaccine development and enhancing its product pipeline, which includes 11 other vaccines in various stages of research [6] - The company has received IND approval for a recombinant respiratory syncytial virus vaccine, marking a significant milestone in its R&D efforts [7] Production Capacity - The company is expanding its production capacity with a facility in Taizhou, Jiangsu, featuring multiple GMP-compliant production lines for various vaccines, ensuring sufficient capacity for future growth [8] - Huili Kangxin® has been adopted in over 30 provinces in China, with a 100% approval rate for product quality and registration [8] Strategic Expansion - Zhonghui Biopharma is pursuing international market registrations and strategic acquisitions, with plans to submit applications in several countries, including Thailand and Canada, to enhance its global footprint [9] - The company has allocated over 10% of its IPO funds for strategic acquisitions, aiming to shorten market entry timelines in Southeast Asia [9]

Core Viewpoint - Zhonghui Biotech-B (02627) experienced a significant stock price increase of 1.35%, closing at 52.5 HKD, following the release of its interim results for the six months ending June 30, 2025, which showed a remarkable revenue growth of 919.25% year-on-year [1] Financial Performance - The company's revenue for the reporting period reached 71.123 million RMB, marking a substantial increase compared to the same period last year [1] - Gross profit amounted to 60.781 million RMB, indicating strong profitability [1] - Research and development expenditures were significantly increased, totaling 98.848 million RMB [1] Company Overview - Zhonghui Biotech is a China-based vaccine company focused on the research, development, manufacturing, and commercialization of innovative vaccines and traditional vaccines using new technologies [1] - The company's product pipeline includes two core products: a quadrivalent influenza virus subunit vaccine and an investigational freeze-dried human rabies vaccine, along with 11 other vaccines in development [1] - All vaccine products and those under development are classified as Category II vaccines in China [1] Development Platforms - The company has established three comprehensive vaccine development support platforms: a gene engineering and protein expression and purification platform, an mRNA vaccine research platform, and an adjuvant development and production platform [1] - As of June 30, 2025, Zhonghui Biotech successfully obtained IND approvals for nine investigational vaccines from the National Medical Products Administration [1]

Core Viewpoint - Zhonghui Biotech-B (02627) reported a significant increase in revenue for the six months ending June 30, 2025, with total revenue reaching RMB 71.123 million, representing a year-on-year growth of 919.25% [1] Financial Performance - The company's gross profit for the same period was RMB 60.781 million [1] - Research and development expenses amounted to RMB 98.848 million [1] Company Overview - Established in 2015, the company is a vaccine manufacturer based in China, focusing on innovative vaccines and traditional vaccines using new technological methods [1] - The vaccine pipeline includes products that meet domestic needs and comply with global standards, featuring two core products: a quadrivalent influenza virus subunit vaccine and an investigational freeze-dried human rabies vaccine [1] - The company has an additional 11 investigational vaccines targeting various diseases with high vaccination demand [1] Research and Development Capabilities - The company has established three comprehensive vaccine development support platforms: a gene engineering and protein expression and purification platform, an mRNA vaccine research platform, and an adjuvant development and production platform [1] - Unique proprietary technology platforms, including large-scale amplification, polysaccharide conjugation, and microbiology and immunology research platforms, enhance the company's R&D capabilities [1] - As of June 30, 2025, the company successfully obtained IND approvals for nine investigational vaccines from the National Medical Products Administration [1]