2025Q1疫苗行业跟踪报告（附批签发） 西南证券研究院 2025年5月 分析师：杜向阳 执业证号：S1250520030002 电话：021-68416017 邮箱：duxy@swsc.com.cn 联系人：雷瑞 邮箱：leir@swsc.com.cn 2012.08.13 10287 Hib疫苗：2025Q1批签发7批次(-50%)。 肠道病毒疫苗：2025Q1，EV71疫苗批签发4批次(-69%) 。 数据来源：医药魔方，中检院，西南证券整理，备注：本篇报告括号内均为同比变化数据，后续不一一指出，数据整理截至2025.4.7 1 2025Q1疫苗批签发批次情况 重点疫苗批签发情况： 多联苗：2025Q1，四联苗无批签发，五联苗同比下滑，赛诺菲巴斯德五联苗批签发17批次(+0%)。 肺炎疫苗：2025Q1，肺炎疫苗批累计签发23批次(-30%) ，其中13价肺炎疫苗批签发19批次(+0%)，其中 沃森生物9批次，民海生物6批次，辉瑞4批次。23价肺炎疫苗批签发4批次(-71%)。 HPV疫苗：2025Q1批签发57批次(+63%)。其中双价HPV疫苗批签发42批次（+367%），双价苗需求快速 增长，全部 ...

Total revenues of €49.2 million compared to €32.8 million in the first quarter of 2024Cash and cash equivalents of €153.0 million at end of March 2025Further clinical and regulatory progress2025 financial outlook confirmed Saint-Herblain (France), May 7, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported its financial results for the first quarter ending March 31, 2025, provided key corporate updates and confirmed its 2025 financial guidance. The condensed co ...

Core Viewpoint - Valneva SE reported strong financial results for Q1 2025, with significant revenue growth and reduced operational cash burn, while confirming its financial guidance for the year [3][5][6]. Financial Performance - Total revenues for Q1 2025 were €49.2 million, a 50.3% increase from €32.8 million in Q1 2024 [5][6]. - Product sales reached €48.6 million, up 51.2% from €32.1 million in the same period last year [6][31]. - The company reported a net loss of €9.2 million compared to a net profit of €58.9 million in Q1 2024, which included €90.8 million from the sale of a Priority Review Voucher [6][45]. - Operating cash burn was reduced by 71% to €8.1 million in Q1 2025 from €28.4 million in Q1 2024 [6][47]. - Cash and cash equivalents stood at €153.0 million as of March 31, 2025, down from €168.3 million at the end of 2024 [6][50]. Product Sales and Market Developments - IXIARO®/JESPECT® sales increased by 65.5% to €27.5 million, driven by demand from travelers and the U.S. Department of Defense [10][32]. - DUKORAL® sales grew 9.4% to €12.3 million, supported by a supply agreement with the French government [12][33]. - IXCHIQ® sales surged to €3.0 million from €0.2 million in Q1 2024, with initial sales related to a chikungunya outbreak response [13][34]. - Third-party product sales increased to €5.8 million from €4.1 million, reflecting recovery from previous supply constraints [18][35]. Research and Development Highlights - Valneva is advancing its Lyme disease vaccine candidate, VLA15, with primary vaccinations completed and data expected by the end of 2025 [20][21]. - The company is also developing a tetravalent Shigella vaccine candidate, S4V2, with ongoing Phase 2 studies [23][24]. - A Phase 1 trial for a Zika vaccine candidate, VLA1601, is currently underway, with results anticipated this year [28][29]. Strategic Partnerships and Regulatory Progress - Valneva secured a $32.8 million supply contract for IXIARO® with the U.S. Department of Defense [7][11]. - The company received marketing authorization for IXCHIQ® in the UK and Brazil, marking significant milestones for its chikungunya vaccine [7][14][15]. - Valneva has entered into a licensing agreement with the Serum Institute of India to expand access to its chikungunya vaccine in Asia [15][61]. Financial Outlook - The company expects product sales to grow to €170-180 million in 2025, with total revenues projected to reach €180-190 million [6][5]. - R&D investments are anticipated to be between €90-100 million in 2025, partially offset by grant funding and tax credits [6][5].

Core Insights - Bavarian Nordic A/S has received an additional contract option from BARDA valued at USD 143.6 million for the supply of freeze-dried JYNNEOS smallpox vaccine [1][10] - The new contract options will support the manufacturing and supply of the freeze-dried formulation, which has an extended shelf life, with deliveries planned for 2026 [2][8] Financial Guidance - Bavarian Nordic's financial guidance for 2025 remains unchanged, projecting total revenues between DKK 5,700 million and DKK 6,700 million, with an EBITDA margin of 26-30% [3] - Revenue from the Public Preparedness business is expected to be between DKK 3,000 million and DKK 4,000 million, with DKK 2,650 million already secured, reflecting an increase of DKK 150 million due to the exercise of the options [3] Product Development and Approval - The freeze-dried formulation of JYNNEOS was approved by the FDA in March 2025, offering advantages in transportation, storage, and shelf life compared to the liquid-frozen version [8] - JYNNEOS is the first smallpox vaccine developed under Project BioShield, which aims to enhance the availability of medical countermeasures against various threats [6] Historical Context - Bavarian Nordic has been collaborating with the U.S. government since 2003 for the development and supply of smallpox vaccines, including the liquid-frozen formulation supplied since 2010 [5][7] - The company has a ten-year contract awarded in 2017, which includes options valued at USD 299 million for the fill and finish of freeze-dried vaccines, of which USD 284 million has been exercised to date [7]

COPENHAGEN, Denmark, May 2, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in the United Kingdom (UK) for VIMKUNYA® (recombinant, adsorbed) for active immunization for the prevention of disease caused by chikungunya virus in individuals 12 years and older. The vaccine was approved following MHRA review under the international recognition procedure, which is a targeted assessment that recognize ...

Core Viewpoint - 康希诺 has shown significant improvement in its financial performance, with a notable reduction in losses and a positive revenue growth trajectory, indicating a potential recovery from the impacts of the COVID-19 pandemic [2][3][4]. Financial Performance - In Q1 2025, 康希诺 reported revenue of 1.074 billion yuan, a year-on-year increase of 20.02%, while the net loss attributable to shareholders was 11.55 million yuan, down from a loss of 170 million yuan in the same period last year [2]. - The company achieved a substantial reduction in losses due to several factors, including the absence of one-time special losses from the previous year, increased market share of its meningococcal products, and additional government subsidies [2][4]. - For the full year 2024, 康希诺's revenue grew by 137.01% to 846 million yuan, with a narrowed net loss of 379 million yuan [3]. Market Position and Competitiveness - 康希诺's performance stands out in a challenging vaccine market, where most domestic vaccine manufacturers reported declines in revenue [4][3]. - The company’s meningococcal vaccine, 曼海欣, has become a key revenue driver, contributing significantly to its Q1 2025 revenue [7][10]. - Despite the overall decline in the meningococcal vaccine market, 康希诺's products have shown growth, with 曼海欣's approval and sales expected to continue expanding [9][10]. Product Pipeline and Future Prospects - 康希诺 has two approved meningococcal vaccines, with 曼海欣 being the primary revenue contributor, and is actively pursuing market expansion both domestically and internationally [6][10]. - The company is also awaiting approval for its 13-valent pneumococcal conjugate vaccine, which could further enhance its product portfolio, although competition in this segment is strong [11]. - The future growth potential of 康希诺 remains uncertain, as its current and upcoming products may not provide significant long-term growth opportunities [11].

Core Points - Valneva SE's chikungunya vaccine IXCHIQ has faced updated recommendations from France's Haute Autorité de Santé (HAS) due to serious adverse events reported in elderly individuals with comorbidities during the vaccination campaign in La Reunion and Mayotte [1][2] - The French health authorities have suspended the use of IXCHIQ for individuals aged 65 and older while maintaining its recommendation for those aged 18 to 64 [2] - Valneva has supplied 40,000 doses of IXCHIQ to La Reunion amid a significant chikungunya outbreak with approximately 40,000 confirmed cases since the start of 2025 [1][4] Company Overview - Valneva is a specialty vaccine company focused on developing, manufacturing, and commercializing vaccines for infectious diseases, addressing unmet medical needs [7] - The company has a strong track record in advancing vaccines from early research and development to approvals, currently marketing three proprietary travel vaccines [8] - Valneva's revenues from its commercial business support the advancement of its vaccine pipeline, which includes candidates for Lyme disease, Shigella, Zika virus, and other public health threats [9] Industry Context - Chikungunya virus (CHIKV) is a mosquito-borne disease that has been identified in over 110 countries, with significant medical and economic burdens expected to grow due to climate change [6] - The World Health Organization (WHO) has recognized chikungunya as a major public health problem, highlighting the need for effective vaccines and interventions [6]

Urges Stockholders to Vote "FOR" All Four Dynavax Director Nominees on the GOLD Proxy Card Highlights Record Financial and Operational Results, Balanced Capital Allocation Strategy andMeaningful Board Refreshment Underscores Deep Track's Value Destructive, Short-Term Focus and Unnecessary Proxy Contest EMERYVILLE, Calif., April 17, 2025 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX) ("Dynavax" or the "Company"), a commercial-stage biopharmaceutical company developing and commercializing inn ...

Core Insights - Valneva SE has received marketing authorization from Brazil's ANVISA for its single-dose chikungunya vaccine IXCHIQ®, marking the first approval of a chikungunya vaccine in an endemic country [1][2] - The vaccine is part of Valneva's strategy to enhance access in low- and middle-income countries (LMICs), supported by CEPI and the EU [1][6] - The approval allows for large-scale clinical trials in Brazil, including Phase 4 trials to gather additional data on vaccine effectiveness [3] Company Developments - IXCHIQ® is already approved in the EU for individuals aged 12 and older and in the U.S., Canada, and the U.K. for those aged 18 and older [2] - Valneva is collaborating with Instituto Butantan for local manufacturing and distribution of the vaccine in Brazil, with potential approval for another vaccine candidate, VLA1555, expected in mid-2025 [4] - The company aims to ensure rapid access to its vaccines in Brazil and other regional markets, addressing a significant public health need as Brazil reported over 1 million chikungunya cases since 2019 [5][6] Clinical Trials and Research - Valneva is conducting a Phase 2 trial in children aged 1 to 11 years in the Dominican Republic and Honduras, with positive results reported in January 2025 [7] - A pivotal Phase 3 study in children is expected to begin in Q4 2025, with plans to evaluate the vaccine in pregnant women in outbreak-affected countries [8] Public Health Context - Chikungunya virus, transmitted by Aedes mosquitoes, has caused significant outbreaks globally, with over 720,000 cases reported in the Americas from January to July 2023 [5][10] - The World Health Organization has identified chikungunya as a major public health issue, with the disease's economic impact expected to grow due to climate change [10]

Core Insights - Valneva SE and LimmaTech Biologics AG have initiated a Phase 2 infant safety and immunogenicity study for Shigella4V2 (S4V2), a tetravalent bioconjugate vaccine candidate against shigellosis, marking a significant step in vaccine development [1][3][4] Industry Overview - Shigellosis is the second leading cause of fatal diarrheal disease globally, with an estimated 165 million infections annually, of which 62.3 million occur in children under five years [2][6] - The disease results in approximately 600,000 deaths each year, highlighting the urgent need for an effective vaccine [6] Study Details - The Phase 2 study (Identifier: NCT06523231) will involve around 110 nine-month-old infants to determine the optimal vaccine dosage for future Phase 3 trials [3] - The study is randomized, controlled, and blinded, taking place at a single site in Kenya, with results expected in the second half of 2025 [3] Company Statements - Dr. Juan Carlos, Chief Medical Officer of Valneva, emphasized the unacceptable mortality rates from shigellosis and the company's commitment to developing vaccines for unmet medical needs [4] - Dr. Patricia Martin, COO of LimmaTech, highlighted the trial's initiation as a significant milestone in their collaboration with Valneva to address this global health threat [4] Regulatory Status - The U.S. FDA has granted Fast Track designation to S4V2, recognizing its potential to address a serious health condition and fill an unmet medical need [5]