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中慧生物-B(02627):重组呼吸道合胞病毒疫苗(CHO细胞)(佐剂)的IND获中国CDE及美国FDA批准
智通财经网· 2025-08-17 11:30
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]
中慧生物-B(02627) - 自愿性公告 -重组呼吸道合胞病毒疫苗(CHO细胞)(佐剂)的IND获...
2025-08-17 11:15
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 ...
中慧生物暴涨背后:中国真的需要319元/针的流感疫苗?
Guan Cha Zhe Wang· 2025-08-15 14:13
Group 1: Company Overview - Jiangsu Zhonghui Yuantong Biotechnology Co., Ltd. (Zhonghui Bio) successfully listed on the Hong Kong Stock Exchange on August 11, with an initial price of HKD 12.90, surging 164% on the first day to close at HKD 33.28, marking a 158% increase and setting a record for new stock listings in 2025 [1][3] - The company’s market capitalization approached HKD 17.2 billion after two days of trading, with a cumulative increase of over 238% [1] - Zhonghui Bio's core product, the four-valent influenza virus subunit vaccine "Hui Er Kang Xin®," received approval in May 2023 and is positioned as a high-purity alternative to traditional vaccines, boasting a significant technological advantage [1][5] Group 2: Market Dynamics - Despite the initial capital enthusiasm, the influenza vaccine market in China faces challenges, with a vaccination rate stagnating at 3.8%, significantly lower than the U.S. [2][8] - The market is saturated with 26 listed influenza vaccines and 19 in development, leading to intense competition and price wars, which have resulted in significant revenue declines for major players [2][11] - The industry is experiencing a structural dilemma, with high production costs and low vaccination rates creating a challenging environment for companies like Zhonghui Bio [8][12] Group 3: Financial Performance - Zhonghui Bio reported a net loss of CNY 425 million in 2023, with projections of a reduced loss of CNY 259 million in 2024 [12][13] - The company’s revenue is heavily reliant on its single product, which is priced significantly higher than the industry average, leading to challenges in market penetration [12][14] - High research and development expenditures have been a double-edged sword, with R&D costs constituting a substantial portion of total expenses [12][15] Group 4: Future Prospects - Zhonghui Bio is exploring international markets as a strategy to mitigate domestic market pressures, with plans to register in regions like Macau and the Philippines, and to enter markets such as Canada and Singapore [15][16] - The company’s success in international expansion will depend on overcoming patent barriers and adapting to local production requirements [15][16] - The ongoing transition in the vaccine industry from imitation to innovation presents both challenges and opportunities for Zhonghui Bio as it seeks to establish a competitive edge [16]
中慧生物暴涨背后:3%接种率的中国,需要319元/针的流感疫苗?
Guan Cha Zhe Wang· 2025-08-15 10:07
Core Viewpoint - Jiangsu Zhonghui Yuantong Biotechnology Co., Ltd. (Zhonghui Bio) successfully listed on the Hong Kong Stock Exchange, with an initial price of HKD 12.90, and saw its stock price surge by 158% on the first day, setting a record for new IPOs in Hong Kong in 2025 [1][5]. Company Performance - On the second day of trading, Zhonghui Bio's stock continued to rise, with a cumulative increase of over 238% within two days, bringing its market capitalization close to HKD 17.2 billion [1]. - The public offering was oversubscribed by over 4,000 times, with frozen funds reaching HKD 210 billion, making it the hottest IPO project under the 18A clause this year [1]. Product and Technology - The capital market's enthusiasm for Zhonghui Bio is attributed to its core technology, the domestically exclusive quadrivalent influenza virus subunit vaccine "Hui Er Kang Xin®," which was approved in May 2023 [1]. - This vaccine utilizes a subunit technology route, which has a 35% global market share, offering significant advantages over traditional split vaccines in terms of purity and lower adverse reactions [1][7]. - The vaccine has shown superior immunogenicity, with a GMT ratio of 1.52 and an adverse reaction rate of 9.7%, compared to 18.3% for the control group [7]. Market Context - Despite the initial success, the long-term outlook for the influenza vaccine market in China is concerning, with a vaccination rate stagnating at 3.8%, only one-tenth of that in the U.S. [2][4]. - The market is crowded, with 26 listed influenza vaccines and 19 in development, leading to price wars and financial pressure on many companies [3][2]. Financial Background - Zhonghui Bio reported a net loss of RMB 259 million for 2024, highlighting the financial challenges in a competitive market [3]. - Prior to its IPO, the company underwent significant capital raising, including a total of RMB 1.3 billion in A-round financing in April 2019, RMB 1.75 billion in A+ round financing in August 2020, and RMB 6.9 billion in B-round financing in August 2021 [7]. Shareholding Structure - After listing, Zhonghui Bio's shareholding structure is characterized by a controlling shareholder group and diversified institutional investors, with the controlling group holding approximately 41.68% of shares [8]. - Institutional investors include various funds with significant holdings, such as Yingke Innovation and Guohai Innovation [8].
中慧生物-B(02627.HK)拟8月28日举行董事会会议以审批中期业绩
Ge Long Hui· 2025-08-15 09:01
格隆汇8月15日丨中慧生物-B(02627.HK)公告,公司将于2025年8月28日(星期四)举行董事会会议,藉以 (其中包括)考虑及批准公司及其附属公司截至2025年6月30日止6个月未经审核中期业绩及其刊发,以及 考虑派发中期股息建议(如有)。 ...
三大指数周线两连阳 中慧生物等医药股表现抢眼
Xin Lang Cai Jing· 2025-08-15 08:57
Market Performance - The three major indices in Hong Kong stock market rose collectively, with the Hang Seng Index increasing by 1.65% to close at 25,270.07 points, the Tech Index rising by 1.52% to 5,543.17 points, and the National Enterprises Index up by 1.62% to 9,039.09 points [2] - The Hang Seng Index rose from 24,775.73 points at the beginning of the week to above 25,000 points, reaching a historical high of 25,766.62 points during the week [4] Earnings Reports - Tencent reported revenue of 184.5 billion yuan, a year-on-year increase of 15%, with gross profit of 105 billion yuan, up 22%, and operating profit of 69.2 billion yuan, up 18% [6] - JD Group achieved total revenue of 356.7 billion yuan, a 22.4% year-on-year increase, marking a three-year high, but net profit fell by 51% to 6.2 billion yuan [7] - NetEase reported total revenue of 27.9 billion yuan, a 9.4% year-on-year increase, with net profit of 8.6 billion yuan, up 27.25% [8] - Tencent Music had total revenue of 8.44 billion yuan, a 17.9% year-on-year increase, with adjusted net profit of 2.64 billion yuan, up 33% [9] Sector Performance - Pharmaceutical stocks performed strongly, with notable gains from companies like Zhonghui Biological, which surged by 265.74% [10] - Zhonghui Biological's stock price increased by 157.98% on its first day of trading, with oversubscription of 4,007 times [11] - Other pharmaceutical stocks like Silver诺医药 and派格生物科技医药 also saw significant increases, with Silver诺医药 rising by 206.48% [13][14] Broker and Semiconductor Stocks - Broker stocks strengthened, with CITIC Securities, China Galaxy, and CICC rising by 10.98%, 9.48%, and 8.50% respectively, supported by increased trading volumes in the A-share market [15][16] - Semiconductor stocks gained attention, with InnoTech rising by 17.38%, supported by positive outlooks on domestic supply chains and AI applications [17][18] Weakness in Banking and Gaming Stocks - Banking stocks showed slight weakness, with Minsheng Bank, Postal Savings Bank, and Industrial and Commercial Bank falling by 3.60%, 3.29%, and 3.09% respectively [19] - Gaming stocks experienced profit-taking, with IGG, Boyaa Interactive, and Xindong Company declining by 6.63%, 5.80%, and 4.93% respectively [21]
中慧生物-B(02627) - 董事会会议日期
2025-08-15 08:34
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) 董事會會議日期 江蘇中慧元通生物科技股份有限公司(「本公司」)董事(「董事」)會(「董事會」)謹 此宣佈,本公司將於2025年8月28日(星期四)舉行董事會會議,藉以(其中包括) 考慮及批准本公司及其附屬公司截至2025年6月30日止六個月之未經審核中期業 績及其刊發,以及考慮派發中期股息之建議(如有)。 承董事會命 江蘇中慧元通生物科技股份有限公司 執行董事、董事長兼總經理 安有才先生 香港,2025年8月15日 於本公告日期,董事會成員包括:(i)執行董事安有才先生、李潤香女士及何一鳴 先生;(ii)非執行董事程千文先生、于建林先生及杜沐先生;及(iii)獨立非執行董 事李向明先生、李曉青女士及陳乘貝先生。 ...
中慧生物港股上市第4个交易日跌14%
Zhong Guo Jing Ji Wang· 2025-08-14 09:13
Core Viewpoint - Jiangsu Zhonghui Yuantong Biotechnology Co., Ltd. (stock code "Zhonghui Bio", 02627.HK) has experienced a significant decline in its stock price, closing at 44.88 HKD on its fourth trading day, reflecting a drop of 14.02% from its initial offering price [1] Summary by Categories Company Overview - Zhonghui Bio's global offering included a total of 33,442,600 H shares, with 3,996,000 shares allocated for the Hong Kong offering and 29,446,600 shares for international offering [1] Financial Performance - The final offering price was set at 12.90 HKD per share, resulting in total proceeds of 431.4 million HKD. After deducting estimated listing expenses of 48.7 million HKD, the net proceeds amounted to 382.7 million HKD [1] Use of Proceeds - The net proceeds from the global offering will be allocated as follows: approximately 63.6% for the development and registration of core products; about 18.1% for the development and registration of other vaccines in research; around 8.4% for improving processes and commercialization capabilities; approximately 4.9% for the development of technology platforms; and about 5.0% for working capital and other general corporate purposes [1]
港股上新205亿“疫苗新秀” 创始人首谈为何不卷
经济观察报· 2025-08-13 12:57
Core Viewpoint - The article highlights the rapid IPO of Zhonghui Biotech, which achieved a listing on the Hong Kong Stock Exchange in just 10 months, setting a record for the fastest project handled by intermediary institutions [2][4]. Company Overview - Zhonghui Biotech, founded by An Youcai, is a newcomer in the vaccine industry, having been established only 10 years ago and currently offering one vaccine on the market [2][6]. - The company’s flu vaccine is the only quadrivalent subunit vaccine available in the domestic market, priced at 319 yuan per dose, making it the most expensive flu vaccine in China [10][11]. Financial Aspects - The IPO raised approximately 383 million HKD, which will alleviate the company's financial pressure, especially as it faces a bank loan repayment of about 400 million yuan within a year [4]. - As of the end of Q1 2025, Zhonghui Biotech had a cash balance of only 115 million yuan [4]. Market Position and Strategy - Zhonghui Biotech aims to position itself as an international company focused on innovation in the vaccine sector, distinguishing itself from competitors by not participating in the price-cutting trend for flu vaccines [3][10]. - The company is expanding its market reach internationally, particularly targeting Southeast Asia and Latin America, and has formed a strategic partnership with Watson Bio for overseas sales [11]. Product Development - Currently, Zhonghui Biotech has 11 vaccines in its pipeline, with 10 in development and one already on the market [10]. - The company is also working on a human diploid rabies vaccine and other products aimed at replacing imported vaccines and leading globally in vaccine technology [12][13]. Leadership and Expertise - An Youcai, the founder, transitioned into the vaccine industry from a non-biological background, leveraging 15 years of entrepreneurial experience to enhance his expertise in immunology and vaccine development [6][8]. - The company has attracted experienced scientists to its team, including those who have previously worked on significant vaccine projects [7].
港股上新205亿“疫苗新秀” 创始人首谈为何不卷
Jing Ji Guan Cha Wang· 2025-08-13 12:38
Core Viewpoint - Zhonghui Biotech-B (02627.HK) has made a significant debut on the Hong Kong Stock Exchange, with its stock price rising by 158% on the first day, marking the highest first-day gain for a new stock since 2025. The company's market capitalization reached HKD 20.5 billion, ranking fifth among 18 domestic vaccine companies [2][3]. Company Overview - Zhonghui Biotech is a relatively new player in the vaccine industry, having been established only 10 years ago and currently offering just one vaccine on the market, which has been available for less than two years [2]. - The founder, An Youcai, transitioned into the vaccine sector from a non-biological background, emphasizing a commitment to maintaining pricing integrity for its flu vaccine amidst market competition [2][4]. IPO and Financials - The company raised approximately HKD 383 million from its IPO, which will help alleviate its financial pressures, especially considering it had only HKD 115 million in cash at the end of Q1 2025 and needed to repay around HKD 400 million in bank loans within a year [3]. Product and Market Position - Zhonghui Biotech's flu vaccine is the only quadrivalent subunit flu vaccine available in the domestic market, priced at HKD 319 per dose, making it the most expensive flu vaccine in China [8]. - The company has chosen not to participate in the recent price cuts initiated by competitors, focusing instead on a market segment that prioritizes safety and high-quality vaccines [8]. - The flu vaccine generated sales of approximately HKD 259 million in 2024, and the company plans to expand its production capacity from 2 million doses to between 10 million and 15 million doses as it enters international markets [8][9]. Research and Development - Zhonghui Biotech has a pipeline of 11 vaccines, with 10 currently in development. The company is also working on a human diploid rabies vaccine, which is expected to have fewer adverse reactions compared to traditional vaccines [9]. - The company aims to differentiate its products through unique positioning and targeting specific consumer groups, with plans to develop vaccines that can compete with imported products and lead in global technology [10].