On October 22, 2025, 2025年10月22日,Maxvax Biotechnology Co., Ltd. (“Maxvax”) announced that its wholly owned subsidiary, Shanghai Maxvax Biotechnology Co., Ltd., has officially initiated the Phase III clinical trial for its Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell). The first group of participants has been successfully enrolled in Xianning, Hubei Province.. 麦克斯瓦克斯生物技术有限公司(“麦克斯瓦克斯”)宣布,其全资子公司上海麦克斯瓦克斯生物技术有限公司已正式启动重组呼吸道合胞病毒(RSV)疫苗(CHO细胞)的III期临床试验。首批受试者已在湖北省咸宁市成功入组。RSV: The “Invisible Threat” to Public Health 呼吸道合胞病毒:对公共健康的“隐形威胁”Respiratory Syncytial Virus (RSV) is a single-stranded RNA virus that can infect individuals of all ages. Older adults are particularly at risk due to declining immunity and underlying health conditions, which significantly increase the likelihood of severe RSV disease. Infection can lead to serious lower respiratory tract infections, cardiac complications, and worsening of chronic conditions such as COPD, asthma, and chronic heart failure, sometimes resulting in pneumonia, hospitalization, or even death.. 呼吸道合胞病毒 (RSV) 是一种单链 RNA 病毒,可以感染所有年龄段的人。老年人由于免疫力下降和基础健康问题,感染风险尤其高,这显著增加了严重 RSV 疾病的可能性。感染可能导致严重的下呼吸道感染、心脏并发症,并加重慢性阻塞性肺病 (COPD)、哮喘和慢性心力衰竭等慢性疾病,有时甚至引发肺炎、住院或死亡。Studies have shown that RSV and influenza are major causes of respiratory infection–related mortality in older populations. According to research conducted in Guiyang between 2016 and 2020, the mortality rate of RSV infection in patients over 60 years old was 5.8%, higher than that of influenza, and hospitalized elderly patients infected with RSV had a . 研究表明,RSV和流感是导致老年人群呼吸道感染相关死亡的主要原因。根据2016年至2020年在贵阳进行的研究,60岁以上患者中RSV感染的死亡率为5.8%,高于流感,且因RSV感染住院的老年患者具有 。5.4-fold 5.4倍higher risk of death 更高的死亡风险than those not infected. 比那些未感染的人。RSV is characterized by high infectivity and a high rate of severe illness. Natural infection does not provide lasting immunity, and reinfection is common, making RSV a serious global public health concern. At present, no specific antiviral treatment for RSV is available, and clinical management primarily relies on supportive care. RSV具有高传染性和高重症率的特点,自然感染后无法产生持久的免疫力,再感染普遍,是严重的全球公共卫生问题。目前尚无特效抗病毒治疗方法,临床上主要以支持治疗为主。Therefore, vaccination is recognized as the most effective preventive measure. Vaccination, therefore, has become the most promising and preferred strategy for the prevention and control of RSV disease. However, no RSV vaccine has yet been approved for marketing in China.. 因此,接种疫苗被认为是最有效的预防措施。因此,疫苗接种已成为预防和控制RSV疾病的最有前途和首选的策略。然而,目前在中国尚无RSV疫苗获批上市。Recombinant RSV Vaccine (CHO Cell): Innovation Driving Progress 重组RSV疫苗(CHO细胞):创新驱动进步The recombinant RSV vaccine developed by Maxvax is the first domestically developed RSV recombinant protein vaccine to receive clinical trial approval from China’s Center for Drug Evaluation (CDE). The vaccine uses a recombinant protein technology platform, with RSV Pre-F protein as the antigen, combined with the company’s proprietary MA103 adjuvant system. 麦克斯维生物研发的重组RSV疫苗是中国首个获批临床试验的国产RSV重组蛋白疫苗,该疫苗采用重组蛋白技术平台,以RSV Pre-F蛋白为抗原,搭配企业自主研发的MA103佐剂系统。It is designed to . 它是被设计用来。prevent both lower and upper respiratory tract diseases caused by RSV 预防由RSV引起的上下呼吸道疾病, reducing morbidity and mortality in high-risk populations. ,降低高危人群的发病率和死亡率。Results from Phase I and Phase II clinical studies have demonstrated excellent safety, tolerability, and immunogenicity. The Phase III study will be conducted in accordance with international and national regulatory guidelines, using a multicenter, randomized, double-blind, placebo-controlled design. 第一阶段和第二阶段临床研究的结果表明,其安全性、耐受性和免疫原性极佳。第三阶段研究将按照国际和国家监管指南进行,采用多中心、随机、双盲、安慰剂对照的设计。A total of 25,000 eligible participants will be recruited across multiple clinical sites in China to further evaluate the vaccine’s safety, immunogenicity, and protective efficacy, providing key data to support future marketing authorization.. 在中国的多个临床中心招募总共25,000名符合条件的参与者,以进一步评估该疫苗的安全性、免疫原性和保护效力,为未来的上市授权提供关键数据。Collaborative Innovation Accelerating Translation 协同创新加速翻译As China’s first RSV vaccine based on a recombinant protein platform, this clinical trial represents a complex and pioneering effort in design and implementation. Maxvax continues to leverage its leading adjuvant and recombinant protein technology platforms to optimize manufacturing processes, enhance product quality, and ensure safety.. 作为中国首个基于重组蛋白平台的RSV疫苗,其临床试验在设计和执行上代表了一项复杂且开创性的努力。Maxvax持续利用其领先的佐剂和重组蛋白技术平台,优化生产工艺,提升产品质量,并确保安全性。The company collaborates with research institutions and medical centers nationwide to establish rigorous clinical trial protocols and quality control systems, ensuring full oversight throughout the trial process. Maxvax has also engaged domestic and international experts to provide technical guidance and solve challenges in real time, while maintaining close communication with regulatory authorities to ensure compliance and efficient progress.. 公司与全国各研究机构和医疗中心合作,建立严格的临床试验方案和质量控制系统,确保对整个试验过程的全面监督。迈科维克斯还聘请了国内外专家提供技术指导,实时解决出现的挑战,同时与监管机构保持密切沟通,确保合规及高效进展。Through deep integration of industry, academia, clinical research, and regulatory collaboration, Maxvax aims to accelerate the translation of scientific innovation into real-world health solutions—bringing effective, high-quality vaccines to protect public health as soon as possible. 通过产业、学术、临床研究和监管协作的深度融合,Maxvax 致力于加速科学创新向现实健康解决方案的转化,尽快提供有效且高质量的疫苗以保护公共健康。About Maxvax 关于MaxvaxMaxvax 最大疫苗接种量is a global biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative vaccines and novel adjuvants. Guided by the values of 是一家全球生物制药公司,致力于创新疫苗和新型佐剂的研究、开发、生产和商业化。秉承Integrity, Innovation, Collaboration, and Global Service 诚信、创新、协作、全球服务, Maxvax is committed to addressing global public health challenges and delivering solutions for major infectious and chronic diseases. ,Maxvax 致力于应对全球公共卫生挑战,并为重大传染性疾病和慢性疾病提供解决方案。The company focuses on developing innovative vaccines for humans and animals (including companion animals), powered by cutting-edge adjuvant, recombinant protein, and immune evaluation platforms. Maxvax has established a robust vaccine pipeline targeting infectious, allergic, and oncological diseases, with three vaccine candidates currently in clinical development.. 该公司致力于为人类和动物(包括伴侣动物)开发创新疫苗,依托前沿的佐剂、重组蛋白和免疫评估平台。Maxvax 已建立了一个强大的疫苗管线,针对传染性疾病、过敏性疾病和肿瘤疾病,目前有三种疫苗候选药物处于临床开发阶段。