This important milestone will provide countries with an additional option for affordable HPV vaccination and will contribute to sustainable supply of HPV vaccine—ensuring more girls are reached by this lifesaving vaccine.

Walrinvax™, a bivalent human papillomavirus (HPV) vaccine, has been prequalified by the World Health Organization (WHO). Walrinvax is manufactured by Yuxi Zerun Biotechnology Co., Ltd. in Yuxi City, Yunnan Province, China, a fully owned subsidiary of Shanghai Zerun Biotechnology under Walvax Biotechnology Co., Ltd. Walrinvax is designed to protect against HPV types 16 and 18, the most common virus types that lead to cervical cancer. Countries facing barriers to national introduction or struggling to expand their HPV vaccine program due to price or supply constraints will now have another option for affordable, sustainable access.

“There is currently a significant gap in the existing HPV vaccine supply worldwide,” says Mr. Yunchun Li, Board Chairman of Walvax. “With the achievement of WHO prequalification, and our commitment to supplying more than half our HPV production capacity to the global market, Walrinvax can be a great help in the global effort to fill that supply gap.”

HPV is extremely common worldwide. Of the more than 100 types of the virus, at least 14 are cancer causing—including types 16 and 18, which cause about 70 percent of cervical cancers globally. Cervical cancer is a leading cause of cancer death among women in countries with low- and middle-income economies.

HPV vaccines are highly effective. Since their introduction, they have significantly reduced vaccine-type HPV infections and precancerous cervical lesions. WHO’s global strategy to accelerate the elimination of cervical cancer calls on countries to, by the year 2030, fully vaccinate 90 percent of girls against HPV by age 15. WHO recommends one or two doses of HPV vaccine in girls and women between 9 and 20 years of age.

WHO prequalification—which ensures a vaccine meets strict international quality, safety, and efficacy standards—allows Walrinvax to be procured by United Nations agencies and Gavi, the Vaccine Alliance. Walrinvax was licensed for use in China on March 22, 2022, and has been widely administered to girls and women locally, but prequalification allows it to enter the global public vaccine market—a critical step in expanding vaccine access.

PATH has been providing technical assistance to Zerun Bio to support the product development and prequalification process since 2017. Activities included improving the quality management and pharmacovigilance systems and providing chemistry, manufacturing, and controls; quality; and clinical advice for the prequalification dossier.

“The prequalification of Walrinvax will help move the world closer to its HPV vaccination goals, and we are encouraged by Zerun and Walvax’s commitment to serving the global market,” says Yuan Yuan, PATH China country representative. “The addition of another HPV vaccine to the global toolkit will help ensure equitable vaccination for girls in low- and middle-income countries.”

Only four other HPV vaccines are currently prequalified by WHO. Merck International manufactures GARDASIL®, a quadrivalent vaccine that covers HPV types 6, 11, 16, and 18, first licensed in the United States in 2006; and GARDASIL 9, a nonavalent vaccine that covers HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, first licensed in the United States in 2014. GlaxoSmithKline manufactures a bivalent HPV vaccine, Cervarix®, that protects against HPV types 16 and 18, first licensed in Europe in 2007. Xiamen Innovax Biotech Co., Ltd. manufactures Cecolin®, a bivalent vaccine that covers HPV types 16 and 18, first licensed in China in 2019, and to which PATH also provided technical assistance prior to prequalification. GARDASIL 9 is not currently available for Gavi-eligible markets.

About Zerun Bio

Zerun Bio is an innovative biopharmaceutical company focusing on the research, development, and manufacturing of new recombinant human vaccines. The company was founded in 2003 with its R&D facility located in Zhanjiang Hi-Tech Park, Pudong New District, Shanghai, China and its manufacturing operations, which is called Yuxi Zerun Biotechnology Co., Ltd., in Yuxi City, Yunnan Province, China. Zerun Bio is a majority owned subsidiary of Walvax, a company listed on Shenzhen Stock Exchange of China. For more information, please visit https://www.zerunbio.com and https://.

About PATH

PATH is a global nonprofit dedicated to achieving health equity. With more than 40 years of experience forging multisector partnerships, and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world’s most pressing health challenges. For more information, visit https://www.path.org.

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泽润生物的HPV疫苗获得WHO预认证

这一重要里程碑将为各国提供一种可负担的HPV疫苗选择，并有助于确保HPV疫苗的可持续供应——确保更多女孩能够接种这款拯救生命的疫苗。

Walrinvax™ 是一款二价人乳头瘤病毒（HPV）疫苗，已获得世界卫生组织（WHO）预认证。Walrinvax由中国云南省玉溪市的玉溪泽润生物技术有限公司生产，该公司是云南沃森生物技术股份有限公司旗下上海泽润生物技术有限公司的全资子公司。Walrinvax旨在预防16型和18型HPV，这是导致宫颈癌的最常见病毒类型。那些因价格或供应限制而面临国家引进障碍或难以扩展HPV疫苗项目的国家，现在将有另一个可负担、可持续的选择。

“目前，全球现有的HPV疫苗供应存在着显著的缺口，”沃森生物董事长李云春表示。“凭借WHO的预认证成就，以及我们承诺将超过一半的HPV生产能力供应给全球市场，Walrinvax将在填补全球这一供应缺口的努力中发挥重要作用。”

HPV在全球范围内极为普遍。在超过100种HPV病毒类型中，至少有14种是致癌的，其中16型和18型这两种型别导致了全球约70%的宫颈癌。宫颈癌是中低收入国家女性癌症死亡的主要原因之一。

HPV疫苗具有很高的有效性。自推出以来，它们显著减少了疫苗覆盖的HPV类型引起的感染和宫颈癌前病变。WHO的全球策略旨在加速消除宫颈癌，呼吁各国到2030年之前，为90%的女孩在15岁之前接种HPV疫苗。WHO建议9至20岁女孩和女性接种一到两剂HPV疫苗。

WHO预认证——确保疫苗符合严格的国际质量、安全性和有效性标准——允许Walrinvax被联合国机构和Gavi（全球疫苗免疫联盟）采购。Walrinvax于2022年3月22日在中国获得使用许可，并已在中国广泛接种，但预认证使其能够进入全球公共疫苗市场，这是扩大疫苗接种的重要一步。

自2017年起，PATH一直为泽润生物提供技术支持，协助产品开发和预认证过程。这些活动包括提高质量管理和药物警戒系统，提供化学、生产和控制过程、质量、以及预认证文件的临床建议。

“Walrinvax的预认证将有助于推动全球实现HPV疫苗接种目标，我们对泽润生物和沃森生物致力于服务全球市场感到鼓舞，”PATH中国代表袁媛表示。“新一款HPV疫苗的加入将有助于确保中低收入国家女孩的公平接种。”

目前，除Walrinvax外，只有其他四种HPV疫苗获得了WHO的预认证。默克公司生产的GARDASIL®是一种四价HPV疫苗，涵盖6型、11型、16型和18型HPV，2006年首次在美国获得许可；GARDASIL 9，是一种九价HPV疫苗，涵盖HPV 6型、11型、16型、18型、31型、33型、45型、52型和58型，2014年首次在美国获得许可。葛兰素史克公司生产的Cervarix®，是一种二价HPV疫苗，预防HPV 16型和18型，2007年首次在欧洲获得许可。厦门万泰沧海生物技术有限公司生产的Cecolin®，是一种二价HPV疫苗，涵盖HPV 16型和18型，2019年首次在中国获得许可，PATH在其预认证前也提供了技术支持。GARDASIL 9目前在Gavi资助的市场上尚不可用。

关于泽润生物

泽润生物是一家创新型生物制药公司，专注于新型重组人疫苗的研发和生产。公司成立于2003年，其研发设施位于中国上海浦东新区的张江高科技园区，生产实体为玉溪泽润生物技术有限公司，位于中国云南省玉溪市。泽润生物是沃森生物的控股子公司，沃森生物在深圳证券交易所上市。更多信息，请访问 https://www.zerunbio.com和 https://。

关于PATH

PATH是一个致力于实现健康公平的全球非营利组织。拥有超过40年的多部门合作经验，并在科学、经济、技术、倡导等多个领域具有专业知识，PATH开发并推广创新解决方案，以应对全球最紧迫的健康挑战。更多信息，请访问 https://www.path.org。

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