商业化生产能力再获认可！药明海德原液生产厂登革热疫苗项目获巴西ANVISA GMP认证

药明海德 2026-05-26

药明海德（WuXi Vaccines）为药明生物全资子公司，专注于疫苗合同定制研发和生产（CDMO）业务。公司今日宣布其苏州基地的生物药原液生产厂（MFG23）获得巴西国家卫生监督管理局（ANVISA）就布坦坦研究所（Instituto Butantan）登革热疫苗（Butantan-DV）生产项目颁发的GMP认证。

中国苏州，

2026年5月26日

此次GMP认证基于ANVISA对MFG23的全面现场检查，包括质量保证（QA）、质量控制（QC）、生物制药科技(MSAT)、仓库及公用设施。此前，位于同一基地的生物制剂灌装生产厂（DP17）已于2026年2月获得巴西国家卫生监督管理局的登革热疫苗生产项目的GMP认证。

董健先生

药明海德首席执行官

本次原液生产厂的GMP认证，是药明海德第二次获得巴西国家卫生监督管理局认证，也是我们与布坦坦研究院携手推进登革热疫苗项目的重要里程碑，并为我们实现双方共同承诺，提升高质量登革热疫苗可及性打下坚实基础。秉持最高质量标准，依托一体化解决方案和技术平台，药明海德将继续为全球公共卫生赋能，不断提升安全、有效、可负担疫苗的可及性。

根据与布坦坦研究所及布坦坦基金会签署的商业化生产协议，药明海德将为布坦坦研究所提供5剂登革热疫苗的原液与制剂生产，以及质量控制的端到端服务，以快速提升疫苗产能，为巴西民众构筑抵御登革热的防线。该合作预计将为巴西市场提供数千万剂的登革热疫苗。单剂Butantan-DV在2025年11月已获得ANVISA批准，适用于12至59岁人群。

关于药明海德

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药明海德（WuXi Vaccines）为药明生物全资子公司，专注于提供人用疫苗和预防性抗体的合同定制研发和生产（CDMO）业务。公司通过一体化能力和技术平台，赋能合作伙伴加速疫苗与预防性抗体研发和商业化进程。无论是预防性单抗、重组蛋白疫苗、病毒类疫苗、病毒载体疫苗、病毒样颗粒（VLP）疫苗、外膜囊泡（OMV）疫苗、核酸疫苗还是结合疫苗，公司都能够通过精深的技术专长、广泛的监管知识、一流的质量体系、先进的CMC开发能力、多元化的技术平台（如哺乳动物细胞、微生物、病毒、蛋白结合技术）以及充沛的GMP产能，为合作伙伴提供从开发到大规模商业化生产的端到端服务，在全球市场交付疫苗和预防性抗体产品，为公众健康保驾护航。

如需了解更多信息，请访问 https://wuxivaccines.com。

WuXi Vaccines' Drug Substance Facility Receives Brazil ANVISA GMP Certification for Dengue Vaccine Manufacturing

Suzhou, China,

May 26, 2026

WuXi Vaccines, a wholly-owned subsidiary of WuXi Biologics, dedicated to vaccine Contract Development and Manufacturing Organization (CDMO), announced today that its drug substance facility (MFG23) located in Suzhou has received Good Manufacturing Practices (GMP) certification from Brazil's Agência Nacional de Vigilância Sanitária (ANVISA). The facility is providing integrated manufacturing services for Instituto Butantan's dengue vaccine (Butantan-DV) production project.

GMP certification was granted following comprehensive on-site inspections of MFG23, a commercial drug substance manufacturing facility, as well as its QA, QC, MSAT, warehouse, and utilities. Previously, the drug product manufacturing facility (DP17) at the same site received ANVISA GMP certification for the dengue vaccine project in February 2026.

Mr. Jian Dong

CEO of WuXi Vaccines

The GMP certification of our DS facility, our second certification from ANVISA, represents a pivotal step in advancing our dengue vaccine project with Instituto Butantan and establishing a solid foundation to deliver on our shared commitment to expand access to high-quality dengue vaccines. Adhered to premier quality standards and powered by our integrated solutions and technologies, we remain committed to driving greater access to safe, effective, and affordable vaccines worldwide.

Based on the commercial manufacturing agreement with Instituto Butantan and Fundação Butantan, WuXi Vaccines will provide end-to-end services, including drug substance and drug product manufacturing and quality control for the 5-dose dengue vaccine. The partnership will rapidly scale up vaccine capacity, aiming to deliver millions of doses to shield Brazil's population from dengue. In November 2025, the single-dose Butantan-DV received ANVISA approval for use with individuals aged 12 to 59.

About WuXi Vaccines

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WuXi Vaccines, a wholly-owned subsidiary of WuXi Biologics, is a leading contract development and manufacturing organization (CDMO) that focuses on vaccine and preventive antibody’s development and manufacturing. It provides world-class, integrated development and manufacturing platforms to expedite partners’ vaccines and preventive antibodies to the clinical stage and the market, regardless of the modality (i.e., recombinant protein, viral, viral vectored, VLP, OMV, nucleic acid, conjugated vaccines). With its technical expertise, broad regulatory knowledge, premium quality system, advanced CMC development capabilities, multiple production platforms (cell culture, viral, microbial, polysaccharide and protein conjugation), and extensive GMP manufacturing capacities, WuXi Vaccines provides an end-to-end service – from vaccine development to large-scale commercial production and distribution. The company can enable global clients to deliver critical vaccines and preventive antibodies anywhere in the world, making it an essential partner in protecting public health.

For more information about WuXi Vaccines, please visit: https://wuxivaccines.com.

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