每经记者｜陈星 实习生 范芊芊 每经编辑｜文多 4月10日，2021全国疫苗与健康大会在成都召开。会上，国家卫健委医药卫生科技发展研究中心主任、 国务院联防联控机制科研攻关组疫苗研发工作组组长郑忠伟参与了"由新冠疫苗看中国疫苗创新"为主题 的圆桌访谈。 国家卫健委医药卫生科技发展研究中心是在应急状态下成立的，随着一些疫苗进入三级临床试验以及上 市等阶段，后续研究中心的工作逐渐进入常态化。 那如何弥补不足？他说，"十四五"期间，国家大概要投入40亿元左右用于推进病原学和防疫技术体系方 面的研发项目。其次，重大传染病防治专项也会在"十四五"期间尽早投入。另外，目前一些疫苗方面的 突破得益于企业的储备。"俗话说，宁可备而不用，只有这样，我国的科技进步才真正能够追上全球领 先的机构、国家等。"他说。 目前，国内开始推进对大规模人群的中国新冠疫苗接种，但一些公众由于担忧疫苗的安全性、有效性等 而犹豫。 对此，郑忠伟指出，我们要对中国新冠疫苗充满信心。 他介绍，到昨天为止，中国新冠疫苗在全球的使用已经接近2.5亿剂次。从安全性的横向对比来看，中 国新冠肺炎疫苗的安全性非常良好。纵向数据来看，中国新冠肺炎疫苗实际使用的不良 ...

Financial Data and Key Metrics Changes - Total revenues reached EUR 127 million for the nine months ended September 30, 2025, representing a growth of almost 9% compared to EUR 112.5 million in the same period of 2024 [4][16] - Product sales increased to EUR 119.4 million, up 6.2% from EUR 112 million in the first nine months of 2024 [14][16] - Operating loss reported at EUR 53.9 million compared to an operating profit of EUR 34.2 million in the prior year, primarily due to the sale of a priority review voucher in 2024 [18] Business Line Data and Key Metrics Changes - IXIARO sales reached EUR 74.3 million, increasing 12.5% year-over-year, driven by sales to the U.S. Department of Defense and increased sales in Europe [14] - Ducoral sales decreased from EUR 22.3 million to EUR 21.5 million, impacted by foreign currency fluctuations and a transition to a new distributor in Germany [14][15] - Exchange sales significantly increased to EUR 7.6 million from EUR 1.8 million, including the supply of doses to combat chikungunya outbreaks [15] Market Data and Key Metrics Changes - The company is focusing on expanding into low- and middle-income countries (LMICs) for IXIARO, leveraging its differentiated product profile [22] - The chikungunya vaccine, VLA1553, is being positioned for growth in endemic regions and travel sectors, although the U.S. market remains suspended pending FDA review [10][46] Company Strategy and Development Direction - The company aims to achieve sustainable profitability post-approval and commercialization of the Lyme disease vaccine, VLA15, expected to be a major growth driver [21][22] - Valneva is actively identifying new opportunities for its R&D pipeline, aiming to build a coherent strategy for future vaccine candidates [24] - The company is focusing on operational efficiency and reducing cash burn, with a cash position of EUR 143.5 million as of September 30, 2025 [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming Lyme vaccine data, which is anticipated to be a significant catalyst for the company [22][56] - The company is preparing for potential growth in product sales and is focused on strategic investments in R&D [21][24] - There is uncertainty regarding funding for the Zika vaccine candidate, which may affect its development moving forward [51][54] Other Important Information - The company successfully completed debt refinancing, enhancing its financial flexibility [5] - Cash used in operating activities decreased significantly to EUR 28.4 million from EUR 76.7 million in the first nine months of 2024 [20] Q&A Session Summary Question: Timeline for FDA response regarding the chikungunya vaccine - Management indicated there is no predefined process for the FDA response and hopes for collaborative interaction, but no specific timeline can be provided [29] Question: Impact of currency and distributor shift on Ducoral sales - Management acknowledged currency impacts and noted a technical delay in sales due to the transition to a new distributor in Germany, expecting continued growth for Ducoral [30][31] Question: Timing of Lyme phase 3 readout and potential delays - Management stated that Pfizer controls the process and is taking steps to ensure timely results, with no major delays anticipated [36][37] Question: Proposed remedies for the exchange BLA suspension - The response to the FDA focused on medical evidence and positive risk-benefit ratios, with ongoing pharmacovigilance reviews [40] Question: Launch timeline for VLA15 and IXIARO growth drivers - Management confirmed timelines for VLA15 support a launch in late 2027, while IXIARO's growth is expected to continue through expansion in endemic regions and travel markets [45][46] Question: Funding considerations for the Zika vaccine candidate - Management highlighted uncertainty around funding and regulatory pathways, indicating that substantial funding would be necessary to proceed with development [53][54]

Core Viewpoint - The company has initiated Phase I clinical trials for its inhaled tuberculosis vaccine in Indonesia, marking a significant step in its development process [1] Group 1: Clinical Trial Details - The Phase I clinical trial aims to explore the safety and immunogenicity of a single dose of the inhaled tuberculosis vaccine in adults aged 18-49 [1] - The first subject has been enrolled in the Phase I clinical trial in Indonesia [1] Group 2: Vaccine Background - Currently, the BCG vaccine is the only vaccine available globally for tuberculosis prevention, widely administered and crucial for preventing tuberculosis in infants [1] - The effectiveness of the BCG vaccine diminishes over time, and it cannot be enhanced through booster vaccinations [1] - The company has developed a first-generation innovative tuberculosis booster vaccine for individuals who have received the BCG vaccine, which has completed Phase Ia and Ib clinical trials in Canada [1] Group 3: Clinical Data and Efficacy - Clinical data from the trials in Canada have demonstrated the safety of the candidate vaccine and its effectiveness as a booster for the BCG vaccine, highlighting its superiority in mucosal immunity [1]

Core Viewpoint - The company has no plans for acquisition and is focused on its long-term development while enhancing its core competitiveness in the vaccine sector [2] Group 1: Company Strategy - The company emphasizes high-quality development and is actively advancing its research, production, and sales efforts [2] - The company is committed to improving its product pipeline, particularly in adult vaccines, multi-valent vaccines, and mRNA vaccines [2] Group 2: Market Environment - The company acknowledges the opportunities and challenges presented by an aging population and the emergence of new technologies and products [2] - The company aims to enhance its investment value and shareholder return capabilities based on quality improvement [2]

Core Viewpoint - 康希诺生物's stock rose over 5%, reaching HKD 46.38, with a trading volume of HKD 16.1181 million, following the announcement of the initiation of Phase I clinical trials for its inhaled tuberculosis vaccine in Indonesia [1] Group 1: Clinical Development - 康希诺生物 has officially launched Phase I clinical trials for its inhaled tuberculosis vaccine (5-type adenovirus vector) in Indonesia, with the first subject enrolled [1] - The Phase I trial aims to explore the safety and immunogenicity of a single dose of the inhaled tuberculosis booster vaccine in adults aged 18 to 49 [1] Group 2: Financial Performance - 瑞银 has adjusted 康希诺生物's revenue forecasts for 2026 and 2027, increasing the 2026 forecast by 22% and decreasing the 2027 forecast by 9% [1] - 康希诺生物's management reported that the MCV4 vaccine generated revenue of RMB 662 million in the first three quarters of this year, representing a year-on-year growth of approximately 28%, attributed to an expanded age group and ongoing channel penetration [1] - The MCV4 vaccine began exporting to Indonesia in the third quarter, with estimated sales in the millions for this year [1] - The PCV13i vaccine, launched mid-year, has entered approximately 12 provinces, with management aiming to cover half of the provinces by year-end and expand to other markets next year [1]

Financial Data and Key Metrics Changes - For the nine months ended September 30, 2025, the company reported revenues of $2.5 million, down from $3.1 million in 2024, primarily due to the termination of the BARDA Project NextGen contract [13][15] - Research and development expenses for Q3 2025 were $5 million, compared to $7.4 million in 2024, with a nine-month total of $15.1 million versus $16.1 million in 2024 [13][14] - The overall net loss for Q3 2025 was $6.3 million, compared to $5.8 million in 2024, and the year-to-date net loss was $17 million versus $16.7 million in 2024 [15] Business Line Data and Key Metrics Changes - The company is advancing multiple product candidates, including GEO-MVA, GEO-CM04S1, and Gadeptin, with a focus on addressing unmet healthcare needs [4][11] - GEO-MVA has received guidance from the European Medicines Agency for an expedited development path, allowing the company to bypass earlier clinical trial phases [5][6] - GEO-CM04S1 is recognized as a critical vaccine for immunocompromised adults, with ongoing studies focusing on this population [7][8] Market Data and Key Metrics Changes - There is significant government interest in U.S.-based supply chains for vaccines, reflecting a shift towards onshoring initiatives [6] - The company is experiencing increased interest from industry partners and funding organizations, particularly in relation to its vaccine candidates [4][5] Company Strategy and Development Direction - The company aims to develop innovative cancer therapies and infectious disease vaccines, with a focus on expedited registration pathways [11][12] - Strategic partnerships and collaborations are being pursued to support the development and commercialization of its product candidates [11][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress and outlook for its product portfolio, highlighting the potential for GEO-MVA to address global vaccine needs [4][5] - The company is actively engaging with stakeholders, including government entities and international organizations, to advance its vaccine programs [6][38] Other Important Information - The company is exploring various funding strategies to support its clinical programs, including strategic partnerships and non-dilutive funding [15] - The focus remains on advancing clinical evaluations for GEO-MVA and GEO-CM04S1, as well as Gadeptin for oncology applications [11][12] Q&A Session Summary Question: Is there a scenario that could lead to MVA being used by governments before clinical trials? - Management indicated that emergency use licensing through WHO may be possible, but not prior to clinical evaluation [19][20] Question: Can you provide insights on potential collaborations or partnerships? - Management stated that they hold worldwide rights for their product assets and are open to proposals from potential partners, focusing on global registration [27][28] Question: What are the plans for the needle-free administration method for GEO-MVA? - The company is evaluating non-traditional delivery methods in collaboration with Vaxxas and is in discussions regarding manufacturing plans [32][34] Question: Which regions are most supportive of the vaccine programs? - Management highlighted significant interest in the Southern Hemisphere for GEO-MVA and ongoing concerns regarding mpox outbreaks in various regions [38][40] Question: Will there be a biosimilar version of Pembro available by the time Gadepin is approved? - Management expressed uncertainty but noted potential interest in developing Gadepin with various immune checkpoint inhibitors [43]

Group 1 - Jiangsu Zhonghui Yuantong Biotechnology Co., Ltd. and its subsidiary Yihui Biotechnology (Shanghai) Co., Ltd. have successfully initiated Phase I clinical trials for two new influenza vaccines: "Influenza Virus Subunit Vaccine (Adjuvant)" and "Quadrivalent Influenza Virus Subunit Vaccine (Adjuvant)" in Hubei province [1] - The World Health Organization (WHO) reports that there are approximately 3 to 5 million severe cases of influenza globally each year, with an average of about 88,000 excess deaths due to respiratory diseases caused by influenza in China from 2010 to 2015 [3] - The overall vaccination rate for influenza in China remains low, with only 3.84% during the 2022-2023 flu season, indicating a significant challenge in establishing an effective immune barrier against influenza [3] Group 2 - The "Adjuvanted Influenza Virus Subunit Vaccine" is designed to meet the vaccination needs of different populations, particularly targeting individuals aged 65 and older, utilizing the company's established platform technology and new adjuvants [4] - The vaccine is administered via intramuscular injection in the deltoid muscle, with low-dose and high-dose groups receiving 0.25ml and 0.5ml per dose, respectively, over a total of one dose on day 0 [4] - Preclinical studies indicate that the adjuvanted influenza virus subunit vaccine significantly enhances antibody levels and neutralizing antibody titers, providing a superior option for the elderly population to combat influenza [4] Group 3 - Zhonghui Biotechnology is focused on the research, development, manufacturing, and commercialization of innovative vaccines and traditional vaccines using new technologies, with a continuous increase in R&D investment [5] - The company has received clinical approval for several products, including recombinant zoster vaccine, adjuvanted influenza virus subunit vaccine, and lyophilized human rabies vaccine, with multiple innovative vaccine pipelines under development [6] - The company has established large-scale production capabilities, with a first-phase facility covering approximately 68 acres and equipped with international-level GMP production lines for influenza raw materials and formulations [6]

Core Viewpoint - The company, CanSino Biologics, has initiated Phase I clinical trials for its inhaled tuberculosis vaccine in Indonesia, marking a significant step in its vaccine development efforts [1] Group 1: Vaccine Development - The inhaled tuberculosis vaccine (5-type adenovirus vector) has officially started Phase I clinical trials in Indonesia, with the first subject enrolled [1] - Currently, the only vaccine available for tuberculosis prevention globally is the BCG vaccine, which has limitations in long-term efficacy and cannot be enhanced through booster shots [1] - The company has developed a first-generation innovative tuberculosis booster vaccine aimed at BCG-vaccinated populations, which has completed Phase Ia and Ib clinical trials in Canada, demonstrating safety and efficacy as a booster [1] Group 2: Technology and Delivery Method - The company has leveraged technology from its inhaled COVID-19 vaccine development to establish a comprehensive inhalation pharmaceutical and quality control system, enhancing the first-generation product and adding antigen components [1] - The inhaled tuberculosis booster vaccine is designed to be delivered via nebulization, which is expected to stimulate pulmonary immune responses to eliminate tuberculosis bacteria and control latent infections [1] Group 3: Clinical Trial Objectives - The Phase I clinical trial aims to investigate the safety and immunogenicity of a single dose of the inhaled tuberculosis booster vaccine in adults aged 18 to 49 [1]

Core Viewpoint - The company has initiated Phase I clinical trials for its inhaled tuberculosis vaccine in Indonesia, marking a significant step in its development of a novel vaccine to enhance protection against tuberculosis [1] Group 1: Vaccine Development - The inhaled tuberculosis vaccine, developed using a 5-type adenoviral vector, has officially started its Phase I clinical trials in Indonesia, with the first subject enrolled [1] - The existing BCG vaccine is the only globally available vaccine for tuberculosis prevention, but its efficacy diminishes over time and cannot be enhanced through booster shots [1] - The company has developed a first-generation innovative tuberculosis booster vaccine aimed at individuals who have received the BCG vaccine, which has shown safety and efficacy in previous clinical trials conducted in Canada [1] Group 2: Technological Advancements - The company has leveraged its technology from the development of inhaled COVID-19 vaccines to establish a comprehensive inhalation pharmaceutical and quality control system [1] - The upgraded inhaled tuberculosis booster vaccine includes additional antigen components and is designed to be delivered via nebulization, potentially stimulating pulmonary immune responses to eliminate tuberculosis bacteria and control latent infections [1]

Core Viewpoint - The company has initiated Phase I clinical trials for its inhaled tuberculosis vaccine in Indonesia, marking a significant step in its vaccine development efforts [1] Group 1: Vaccine Development - The inhaled tuberculosis vaccine, developed using a 5-type adenovirus vector, aims to enhance immunity in individuals previously vaccinated with the BCG vaccine [1] - The BCG vaccine is currently the only vaccine available for tuberculosis prevention, but its efficacy diminishes over time, necessitating the development of a booster vaccine [1] - The company has successfully completed Phase Ia and Ib clinical trials in Canada, demonstrating the safety and efficacy of the tuberculosis booster vaccine [1] Group 2: Technological Advancements - The company has leveraged its experience from developing inhaled COVID-19 vaccines to establish a comprehensive inhalation pharmaceutical and quality control system [1] - The upgraded inhaled tuberculosis booster vaccine includes additional antigen components and is designed to be delivered via nebulization, potentially stimulating pulmonary immune responses [1] - This innovative delivery method aims to clear tuberculosis bacteria, control latent infections, and provide preventive effects against the disease [1]