The first vaccine product approved after the implementation of the vaccine management law! Kexing biological varicella vaccine was approved by National Drug Administration (nmpa)!
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Last Update: 2019-12-28
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Source: Internet
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Author: User
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December 28, 2019 / BIOON / -- Sinovac biotechnology Ltd., a Beijing based biopharmaceutical company, is currently listed on the NASDAQ Global Select Market (NASDAQ GS: SVA), the first Chinese vaccine company to be listed in North America Recently, the company announced that the National Drug Administration (nmpa) has approved the company's varicella vaccine product registration application for the prevention of varicella zoster virus infection in children aged 1-12 years Mr Yin Weidong, chairman, President and CEO of Kexing company, said: "the approval of the company's varicella vaccine will enable us to provide another high-quality product to meet the unmet medical needs of the Chinese population This is the first vaccine product approved by the Chinese government after the promulgation and implementation of the vaccine management law Since the government promulgated the vaccine management law and implemented strict management on the vaccine industry, our ability to continue to obtain product approval has proved our business strength and product quality In addition, there are about 40 countries that have included varicella vaccines in their government funded national immunization programs We have a positive outlook on our ability to provide varicella vaccines to markets outside China and create additional sources of growth " Varicella is a highly infectious disease caused by varicella zoster virus The disease is spread by direct contact or through respiratory droplets and is characterized by continuous, breakable and scabby lesions on the skin and mucous membranes Varicella usually affects children and is relatively benign, but complications can occur in the form of pneumonia and encephalitis After infection, the virus may be reactivated and develop into herpes zoster in the elderly Kexing's varicella vaccine is extracted from Oka strain and carried out in the company's proprietary human diploid cells Kexing company completed the preclinical study of varicella human vaccine and was approved to conduct human clinical trials in October 2015 Phase I clinical trials were completed in 2016 In 2017, the phase III efficacy study in 6000 subjects showed that the vaccine protection rate was 87.1%, which was published in the Journal of clinical microbiology and infection Original source: Sinovac announcements approval of variella vaccine for prevention of variella zoster virus (chickenpox) in children
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