Core Viewpoint - The approval of the first therapeutic HPV vaccine PRGN-2012 fills a treatment gap in the RRP field and is expected to enhance the overall market for innovative therapeutic vaccines [1] Industry Summary - The overseas therapeutic vaccine pipeline is progressing rapidly, with multiple technology platforms emerging, indicating a vibrant and competitive landscape [1] - Significant data releases are anticipated in the near future (1-2 years), suggesting that the industry is entering a phase of intensive catalysts [1] - With the integration of AI, the efficiency of antigen design is expected to improve, potentially accelerating vaccine research and production [1] - There is a recommendation to pay attention to companies involved in therapeutic vaccine development [1]

Financial Data and Key Metrics Changes - The company expects to generate over $300 million in revenue for FY 2025, with guidance between $315 million to $325 million, indicating a significant growth trajectory for its lead asset, HEPLISAV B [52][53]. Business Line Data and Key Metrics Changes - HEPLISAV B has seen increased market share due to its differentiated product profile, requiring only two doses compared to three doses for competitor vaccines, and achieving higher levels of seroprotection in Phase III trials [8][11]. - The retail segment is projected to grow significantly, potentially doubling in size by 2030, with the company currently holding nearly 60% market share in that space [10][11]. Market Data and Key Metrics Changes - The adult hepatitis B vaccine market is expanding, particularly after the ACIP recommended vaccination for all adults, creating a large addressable population [5][6]. - The company has successfully captured market share across key settings, including Integrated Delivery Networks (IDNs) and retail, with a focus on driving growth in these areas [12][15]. Company Strategy and Development Direction - The company aims to leverage its novel adjuvant technology to enhance vaccine efficacy and expand its pipeline, while maintaining a strong financial position to evaluate high-value business development opportunities [3][45]. - The strategy includes focusing on derisked assets and advancing products that have established biological efficacy, which sets the company apart from many other biotech firms [52][53]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to drive growth through HEPLISAV B and the emerging pipeline, emphasizing the importance of executing plans amidst a supportive public health environment for hepatitis B vaccination [22][23]. - The competitive landscape is viewed positively, with the company controlling the narrative in the market due to its focused approach on hepatitis B vaccines [25][27]. Other Important Information - The company is exploring additional opportunities in its pipeline, including a shingles vaccine and a plague vaccine in collaboration with the Department of Defense, which could provide further revenue streams [37][40]. - The company maintains a strong balance sheet and is open to returning capital to shareholders when appropriate, while also considering business development investments [45][48]. Q&A Session Summary Question: What is the company's long-term growth outlook? - The company anticipates significant revenue growth driven by HEPLISAV B and a robust pipeline, with expectations of over $300 million in revenue for FY 2025 [52][53]. Question: How does the company plan to capture market share in the retail segment? - The company projects that the retail segment will represent approximately 50% of the adult hepatitis B market by 2030, leveraging its strong product profile and commercial execution [10][11]. Question: What is the competitive environment like for the company? - The company believes it has a strong position in the market, controlling the narrative and focusing solely on its hepatitis B vaccine, which allows it to effectively compete against larger portfolios of competitors [25][27].

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]

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 ...

Core Viewpoint - 百克生物's performance has significantly declined in 2024, primarily due to poor sales of its shingles vaccine, leading to a substantial drop in revenue and net profit [1][2]. Group 1: Financial Performance - In the first half of 2025, 百克生物 reported revenue of 285 million yuan, a year-on-year decrease of 53.93%, and a net profit of -73.57 million yuan, down 153.47% [1]. - The shingles vaccine sales in 2024 were only 251 million yuan, a dramatic decline of 71.54%, contributing to a 32.64% drop in overall revenue [2]. - The company produced 898,600 doses of the shingles vaccine in 2024 but sold only 200,400 doses, resulting in a 69.8% decrease in sales volume [2]. Group 2: Product Performance - 百克生物's revenue heavily relies on core products such as the chickenpox vaccine, shingles vaccine, and freeze-dried nasal flu vaccine [1]. - The shingles vaccine, which was launched in early 2023, initially contributed significantly to revenue, generating 883 million yuan in its first year [1]. - However, the sales of the shingles vaccine have faced challenges due to low public awareness and willingness to get vaccinated, leading to increased inventory levels by 79.97% [2][3]. Group 3: Market Challenges - The vaccine industry in China is facing multiple challenges, including a decline in the number of vaccine batches approved for non-immunization planning vaccines, with some products seeing a drop of over 50% [3]. - The market for traditional vaccines is becoming increasingly competitive, with more companies entering the market and price reductions for some vaccines [3]. - 百克生物 is also facing pressure from a declining birth rate, which reduces the market capacity for childhood vaccines [3]. Group 4: Future Prospects - 百克生物 is advancing the development of a restructured shingles vaccine amidst intense competition from over ten other companies [3]. - The company has a pipeline of 13 vaccines and 3 monoclonal antibodies, with R&D investment reaching 98.2 million yuan in the first half of the year, accounting for 34.47% of revenue [5]. - A new liquid formulation of the nasal flu vaccine has been approved, which could potentially boost sales if launched in time for the flu season [6].

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 - Baike Biotech (688276) held a performance briefing on September 1, 2025, to discuss its operating results and financial status for the first half of 2025, highlighting challenges in vaccine sales and strategies for recovery [1][2]. Financial Performance - In the first half of 2025, Baike Biotech achieved revenue of 285 million yuan, with a net loss of 73.57 million yuan and a non-recurring net loss of 82.23 million yuan [2]. - The decline in revenue and profit was attributed to external factors, intensified market competition, and decreased willingness among vaccine recipients to get vaccinated [2]. Research and Development - The company has established five core technology platforms for vaccine development, including virus large-scale culture technology, formulation and adjuvant technology, genetic engineering technology, bacterial vaccine technology, and mRNA vaccine technology [3]. - R&D investment in the first half of 2025 was 98.20 million yuan, accounting for 34.47% of revenue, a significant increase from 13.83% in the same period last year [3]. Pipeline Projects - Baike Biotech is focusing on 13 vaccine projects and 3 human monoclonal antibodies for infectious disease prevention [4]. - Key projects include the liquid nasal influenza vaccine, which has received production approval, and the DTP vaccine (three-component), currently in Phase III clinical trials [4]. - The company is also advancing several other vaccines and monoclonal antibodies through various stages of clinical trials, including rabies monoclonal antibody and HSV-2 vaccine [4].

Investment Rating - The report provides a positive outlook on the MASH non-invasive diagnosis technology, suggesting it could accelerate new drug development in the pharmaceutical and biotechnology sector [2]. Core Insights - The pharmaceutical and biotechnology sector experienced a decline of 0.65% from August 25 to August 29, underperforming compared to the Wind All A index (1.9%) and the CSI 300 index (2.71%). Only the medical research outsourcing (4.9%) and other biological products (0.14%) sectors saw gains, while in vitro diagnostics (-4.12%), raw materials (-3.34%), and vaccines (-0.59%) faced significant declines [2][7]. - The FDA has accepted the proposal for using VCTE-LSM as a reasonable alternative endpoint for clinical trials in adults with MASH and moderate to advanced fibrosis. This non-invasive method is expected to enhance patient compliance and could lead to a surge in drug development in the MASH area within the next two to three years [2][13]. - The report emphasizes the potential for domestic companies in China to leverage their cost advantages and forward-looking strategies in the field of non-invasive companion diagnostics, particularly in the MASH drug development competition [2]. Market Weekly Review - The pharmaceutical and biotechnology sector's performance was notably weaker than the broader market indices, with specific sub-sectors like medical research outsourcing and other biological products showing resilience [7][8]. - Individual stocks such as Tianchen Medical (30.1%), Ailis (25.6%), and Maiwei Biotech-U (22.4%) performed well, while stocks like Lifang Pharmaceutical (-13.9%), Yuekang Pharmaceutical (-11.9%), and Kanghua Biotech (-11.1%) faced significant losses [10][12]. Industry News and Key Company Announcements - On August 28, Kangfang Biotech announced that its drug AK112 received approval for treating advanced non-squamous non-small cell lung cancer, with promising clinical trial results expected to be presented at an international conference [12]. - The report highlights various companies' financial performances, with notable revenue changes and profit margins, indicating a mixed outlook across the sector [16][17].

Core Points - The National Immunization Program Expert Advisory Committee has been officially disclosed for the first time since its establishment in 2017, consisting of 30 experts from various fields [1][2] - The committee's role is to ensure independent decision-making based on scientific evidence regarding vaccine safety and efficacy, balancing fiscal and supply-demand considerations [1][2] - The new committee includes an increase of 2 members compared to the previous one, with Wang Junzhi as the chairperson, who has significant experience in vaccine research [2][4] Group 1 - The committee's members come from diverse fields such as epidemiology, microbiology, clinical medicine, health policy, and immunology [2][6] - The committee has previously approved and rejected various vaccination programs based on evidence, indicating a systematic decision-making process [1][2] - The new committee aims to enhance transparency, as this is the first time the member list and working regulations have been publicly shared [2][6] Group 2 - The committee's establishment is seen as a potential opportunity to update the national immunization program, which has not included new vaccines for several years [6][9] - There is a discussion on adjusting the funding model for the immunization program to reduce reliance on government finances, especially in light of declining birth rates [6] - The WHO recommends 10 vaccines for national immunization programs, of which China has not included four, highlighting a gap in vaccine coverage compared to developed countries [7][8]

Core Viewpoint - The report highlights the financial performance and operational challenges faced by Liaoning Chengda Biotechnology Co., Ltd. in the first half of 2025, indicating a significant decline in revenue and profit due to market competition and changes in vaccine demand [3][4][13]. Company Overview and Financial Indicators - Liaoning Chengda Biotechnology Co., Ltd. is primarily engaged in the research, production, and sales of human vaccines, classified under the pharmaceutical manufacturing industry [3][4]. - The company reported a revenue of approximately 706.78 million yuan, a decrease of 19.75% compared to the same period last year [4][13]. - The total profit for the period was approximately 145.96 million yuan, down 46.37% year-on-year, with net profit attributable to shareholders at approximately 122.29 million yuan, a decline of 44.47% [4][13]. - The company's net assets decreased by 2.16% to approximately 9.36 billion yuan, and total assets fell by 2.64% to approximately 9.79 billion yuan [4][13]. Industry Context - The vaccine industry in China is undergoing structural adjustments and upgrades, with a dual management system focusing on public health strategies [6][7]. - The global vaccine market is experiencing rapid growth, with a projected compound annual growth rate of 9.5% due to increased demand and technological advancements [5][6]. - The domestic vaccine market is characterized by intense competition, with over 70 licensed companies, contrasting sharply with the oligopolistic structure seen in the international market [7][9]. Business Operations and Market Position - The company maintains a leading position in the domestic and international markets for human rabies vaccines, supported by a robust sales network and strategic marketing initiatives [11][12][13]. - The company is the only domestic producer of inactivated Japanese encephalitis vaccine, which is gaining market traction through enhanced promotion and distribution efforts [10][12][17]. - The company has a strong research and development pipeline, focusing on various vaccine products, including human diploid rabies vaccine and multi-valent influenza vaccines, to meet market demands [12][17]. Strategic Initiatives - The company is implementing a dual-driven model for domestic and international market expansion, leveraging a self-operated sales team and local partnerships [11][12][15]. - The marketing strategy emphasizes channel consolidation and terminal expansion, with a focus on increasing penetration in community hospitals and health clinics [15][16][17]. - The company is actively pursuing international market opportunities, particularly in developing countries, supported by the "Belt and Road" initiative [11][12][15].