February 22, 2024 Source: drugdu 96
On February 20, the recombinant herpes zoster vaccine, a Class I new drug independently developed by Shanghai Institutes for Biological Products of China, received a notice of approval for clinical trial from the State Drug Administration.
Herpes zoster is a common viral infectious disease caused by the reactivation of varicella-zoster virus latent in the human sensory ganglia, with severe nerve pain and skin herpes as the main symptoms. According to relevant data, there are about 1.56 million new cases of herpes zoster in people aged 50 years and above every year in China. Herpes zoster and its complications seriously affect the work and life of patients.
Vaccination against herpes zoster is an important measure for the prevention of herpes zoster and postherpetic neuralgia, but at present there are limited varieties of herpes zoster vaccine available in China.
Shanghai Institutes for Biological Products (SIBI) has independently developed a recombinant herpes zoster vaccine supplemented with a new immune adjuvant by adhering to the clinical value-oriented approach and focusing on the unmet clinical needs. Preclinical studies have shown that the vaccine has good immunogenicity, can induce a high level of antibody response and cellular immune response, and has good preclinical safety.
Shanghai Research Institute of Biological Products (SRIB) will always adhere to innovation-driven development, and will continue to promote clinical development and registration by continuously increasing investment in scientific research and building a complete R&D technology and industrialization platform. In the future, Shanghai Research Institute of Biological Products will rely on the scale of industry-wide technical capabilities, efficiently promote the clinical trials of the vaccine, and strive for the early launch of the product to better meet the demand for herpes zoster prevention in the context of China's aging population.
https://mp.weixin.qq.com/s/G9G3NVlVsHQzgW723IYEDw
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