Core Viewpoint - Zhonghui Biotech-B (02627) saw a stock increase of over 7%, currently trading at 50.6 HKD with a transaction volume of 13.64 million HKD, following the announcement of its new drug clinical trial approval for a recombinant respiratory syncytial virus vaccine [1] Group 1 - The company announced that its self-developed recombinant respiratory syncytial virus vaccine (CHO cells) has received approval for its Investigational New Drug (IND) application from the National Medical Products Administration (NMPA) in China [1] - The vaccine's IND application has also been approved by the U.S. Food and Drug Administration (FDA) [1] - The vaccine utilizes CHO cells to express modified pre-F proteins, and the company has developed a high-yield monoclonal cell line capable of stably expressing pre-F proteins [1] Group 2 - In preclinical studies, the vaccine demonstrated higher pre-F expression levels, better thermal stability, and superior immunogenicity compared to existing recombinant RSV vaccines on the market [1]

Group 1: Market Overview - The market is anticipating interest rate cuts, supported by domestic personal loan interest subsidy policies, leading to increased capital inflow [1] - The Hang Seng Index is expected to trend upwards, with the probability of a bullish market outlook [1] - The Federal Reserve is expected to adopt a dovish stance in upcoming meetings, which may influence market sentiment [1][8] Group 2: Solar Industry Insights - Multiple photovoltaic companies are set to participate in a meeting to discuss issues such as "anti-involution" and capacity reduction, with potential for storage solutions to be implemented [1] - The price of photovoltaic glass has been adjusted upwards to 11 yuan/m², indicating a rebound in pricing after a period of low prices [5][6] - The industry is experiencing a reduction in effective production capacity, with a cumulative cold repair capacity of 7,750 tons per day, leading to expectations of inventory reduction and price recovery [6] Group 3: Biotechnology Sector - Zhonghui Biotech has received IND approval for its recombinant respiratory syncytial virus vaccine from both the National Medical Products Administration (NMPA) and the FDA [3][4] - The global RSV drug market is projected to grow from $1.8 billion in 2020 to $12.8 billion by 2030, with a compound annual growth rate of 21.4% [4] - Zhonghui Biotech has a comprehensive product pipeline, including 11 vaccines in development, indicating strong growth potential in the biotech sector [4]

Core Viewpoint - Jiangsu Zhonghui Yuantong Biotechnology Co., Ltd. (referred to as "Zhonghui Bio") has achieved a significant milestone in its research and development by obtaining IND approval for its recombinant respiratory syncytial virus (RSV) vaccine from the National Medical Products Administration (NMPA) in China, marking the first dual approval for clinical trials in both China and the United States for the company [1][5] Company Developments - The RSV vaccine has also received clinical approval from the U.S. Food and Drug Administration (FDA), showcasing the company's research capabilities and marking a key breakthrough in its drug development [1] - The vaccine utilizes innovative technology with fully independent intellectual property rights and has shown promising results in preclinical studies, including the ability to stimulate high-titer neutralizing antibodies against RSV A2 and B strains [7] - The vaccine's pre-F antigen structure exhibits excellent thermal stability, allowing for long-term storage in liquid form at 2-8°C, which optimizes production processes and reduces costs, enhancing product accessibility [7] Market Potential - The global RSV drug market, including treatment and prevention, is projected to grow from $1.8 billion in 2020 to $12.8 billion by 2030, with a compound annual growth rate (CAGR) of 21.4%, indicating a significant market opportunity for Zhonghui Bio's RSV vaccine [6] - The World Health Organization (WHO) has elevated RSV to a global public health intervention priority, further stimulating interest in RSV immunization solutions [6] Financial Performance - Zhonghui Bio's recent IPO on the Hong Kong Stock Exchange received overwhelming market response, with over 190,000 subscriptions and an oversubscription rate exceeding 4,000 times, raising over HKD 200 billion [8] - The company's core product, Huiru Kangxin®, is the first and only approved quadrivalent influenza virus subunit vaccine in China, contributing to projected sales revenue of CNY 260 million in 2024 [8] - The company has a robust pipeline with 11 other vaccines under development, covering various diseases, and has received multiple new drug clinical approvals [8]

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 ...

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]

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].

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)。 ...