On October 14, 2025, the registration application for the Adjuvanted Recombinant Herpes Zoster Vaccine (CHO Cell) independently developed by Shanghai Maxvax Biotechnology Co., Ltd. (hereinafter referred to as “Shanghai Maxvax”), a wholly-owned subsidiary of Chengdu Maxvax Biotechnology Co., Ltd. (“Maxvax Biotech”), has been officially accepted by Chinese national regulatory authorities(Acceptance No. CXSS2500114). Earlier, Shanghai Maxvax obtained its Drug Manufacturing License for Preventive Biological Products, marking a significant milestone in Maxvax’s transformation from an R&D-driven company to a fully integrated biopharmaceutical enterprise with industrial-scale operations.

Innovative Breakthrough — A New Choice for National Health Protection

Herpes zoster (shingles) is an acute infectious disease of the nerve ganglia caused by the reactivation of the varicella-zoster virus (VZV). Its incidence increases significantly with age, with people over 50 at particularly high risk. However, recent years have seen a growing number of cases among younger adults as well. Both herpes zoster and its complications, such as postherpetic neuralgia, severely affect patients’ quality of life and impose a heavy healthcare burden on society.

Maxvax’s recombinant herpes zoster vaccine is classified as a Category 1.3 new drug. It adopts a recombinant protein technology route and incorporates the company’s proprietary adjuvant system MA105—the first domestically developed composite adjuvant vaccine with independent intellectual property rights in China. The vaccine is intended for the prevention of herpes zoster in adults aged 40 and above caused by the varicella-zoster virus.

The Phase III clinical trial employed a rigorous, multicenter, randomized, double-blind, placebo-controlled design, led by the Henan Provincial Center for Disease Control and Prevention (CDC), with Yunnan, Hebei, and Hubei CDCs serving as sub-centers. The study aimed to evaluate the vaccine’s safety, efficacy, and immunogenicity in individuals aged 40 years and older, successfully enrolling 25,000 participants.
Preliminary clinical analysis indicated that the vaccine’s primary efficacy endpoint met the predefined success criteria, demonstrating strong protection against herpes zoster across all age groups ≥40, along with an excellent safety and reactogenicity profile. Based on these positive results, Maxvax has submitted a marketing authorization application for the product. Once approved, the vaccine is expected to provide a safe, effective, and affordable new option for the prevention and control of herpes zoster in China.

Building Compliance Foundations — Accelerating Industrialization

Shanghai Maxvax has established a modern GMP-compliant vaccine manufacturing facility, designed as an intelligent factory that meets the requirements for digitalized production and quality management. The facility features an integrated information platform encompassing data acquisition (SCADA), manufacturing execution (MES), laboratory information management (LIMS), warehouse management (WMS), and quality systems (QMS, DMS, TMS), ensuring full traceability and verification across the entire production and quality control process.

The company has also built a GMP-standard quality management system, continuously improved through multiple rounds of on-site audits by domestic and international experts. Within this facility, Maxvax successfully completed Phase III clinical-scale production of both the recombinant herpes zoster vaccine and its respiratory syncytial virus (RSV) vaccine candidates, laying a strong foundation for future commercialization.

Message from the Founder

Dr. Dexiang Chen, Founder and General Manager of Maxvax, commented:

“The successful acceptance of our herpes zoster vaccine registration application and the granting of the production license demonstrate Maxvax’s innovation capabilities in novel adjuvants, recombinant protein platform technologies, quality management systems, and clinical development. It also showcases the growing industrialization capacity of domestic vaccine enterprises striving for high-quality development.”

“We are deeply grateful for the strong support from government agencies at all levels, particularly the Shanghai Municipal Medical Products Administration, which provided continuous policy guidance, inspections, and professional supervision throughout the project. Their efforts have been instrumental in facilitating our license approval and registration process.”

“Looking ahead, we will continue to uphold a spirit of scientific rigor, working closely with the National Medical Products Administration (NMPA) during the technical review and on-site verification stages, while steadily advancing commercial production and market readiness. At the same time, Maxvax will actively explore global collaboration opportunities to bring China’s innovative vaccines to the international stage.”

About Maxvax

Maxvax is a global biopharmaceutical company committed to the research, development, production, and commercialization of innovative vaccines and novel adjuvants. Guided by the values of Integrity, Innovation, Collaboration, and Global Service, the company envisions providing effective solutions to major global public health challenges and advancing disease prevention worldwide.

Maxvax focuses on the development of innovative human and veterinary (including companion animal) vaccines, leveraging its cutting-edge adjuvant, recombinant protein, and immune evaluation platforms. The company has established a rich R&D pipeline addressing infectious, allergic, and oncological diseases, with three vaccine candidates currently in clinical trials.