The application for registration of recombinant herpes zoster vaccine (CHO cell) drug has been accepted

Herpes zoster is an acute ganglion infectious diseases caused by reactivation of varicella zoster virus (VZV). The incidence rate increases significantly with age. People over 50 years old have a high incidence of herpes zoster. However, the incidence of herpes zoster shows a younger trend, and cases of herpes zoster also gradually appear in young people. Herpes zoster and its postherpetic neuralgia not only seriously affect the quality of life of patients, but also bring a heavy social and medical burden.

The herpes zoster vaccine product developed by Maikokang Biotechnology is a Class 1.3 new drug, using recombinant protein technology route and equipped with a newly developed adjuvant system MA105. It is the first domestically developed composite adjuvant system innovative vaccine with independent intellectual property rights, suitable for preventing herpes zoster caused by varicella zoster virus in people over 40 years old.

The Phase III clinical trial of this product adopts a scientifically rigorous multicenter, randomized, double-blind placebo-controlled design, with the Henan Provincial Center for Disease Control and Prevention as the leading unit and the disease control and prevention centers in Yunnan, Hebei, and Hubei provinces as sub centers. The aim is to evaluate the safety, efficacy, and immunogenicity of this product after vaccination in the population aged 40 years or older, and ultimately successfully enrolled 25000 subjects. At present, clinical analysis data shows that the main protective efficacy has reached the predetermined threshold of the protocol, and the vaccine has demonstrated good herpes zoster prevention effect in all age groups aged ≥ 40, while also having good safety. Based on the positive clinical research results mentioned above, Maikokang Biotechnology has submitted a drug marketing registration application. The promotion and launch of this product will provide a safe, effective, and affordable new option for the prevention and control of herpes zoster.

Shanghai MAXVAX has established a modern vaccine production base that meets GMP standards, with the goal of building an intelligent factory to meet the requirements of information technology control for vaccine production and inspection. It has built a comprehensive information platform covering data acquisition (SCADA), production (MES), inspection (LIMS), warehousing (WMS), and quality management (QMS, DMS, TMS), ensuring traceability and verifiability of the entire production and quality management process. Simultaneously building a quality management system that complies with Chinese GMP standards, and continuously improving the quality system through multiple rounds of on-site audits by domestic and foreign experts. And successfully completed the commercial production of Phase III clinical samples for recombinant herpes zoster vaccine and respiratory syncytial virus (RSV) vaccine at this base.