Sinovac Dalian has received approval from the China Food and Drug Administration (CFDA) to start human clinical trials on its varicella vaccine candidate.
The clinical trial application for the varicella vaccine was officially accepted by CFDA in January 2013 following a preclinical study.
As part of preparation for human clinical trials, Sinovac Dalian is currently finalising the trial protocol, confirming the site, training staff and preparing for volunteer screening.
Sinovac Dalian intends to complete the human clinical trial of the varicella vaccine candidate in 2017.
Development of the company’s varicella vaccine candidate started in 2010. It is a live attenuated vaccine derived from a human cell line.
The company expects to be able to commercialise its varicella vaccine by the end of 2019.
Simultaneously, the company is renovating an existing building on its Dalian campus to serve as the commercial production plant for the varicella vaccine.
The manufacturing plant will have a designed annual capacity of five million doses.
Eventually, the company intends to develop a measles-mumps-rubella-varicella (MMRV) combination vaccine.
Additionally, the company has licensed a mumps vaccine for sale in China and a clinical trial approval for its internally-developed rubella vaccine. It also plans to start development of a measles vaccine.
The varicella vaccine is currently sold exclusively in the private-pay market in China by four domestic producers. In some regions the vaccine is included in the emergency immunisation programmes of several provinces for free vaccination due to outbreaks.
Sinovac chairman, president and CEO Weidong Yin said: "Obtaining the clinical trial approval marks a significant step in the R&D process for our varicella vaccine candidate.
"Once commercialised, this vaccine will be supplied to the existing market demand, support Sinovac Dalian for its asset utilisation, cash flow and profitability in the near future, and position us to capture share with the potential market expansion in the coming years.
"Meanwhile, there is a meaningful opportunity for an MMRV vaccine in the private-pay market in the future. This represents another milestone as we further develop our vaccine product portfolio to fulfill China’s unmet medical needs."
According to the China Centres for Disease Control and Prevention (CCDCP), the varicella vaccine is recommended to children over 12 months, with different immunization schedules implemented in different provinces.