Green Cross has won the approval of phase 1 clinical trial plan of BCG vaccine, GC3107, which prevents tuberculosis.
The trial evaluates the vaccine’s safety and effectiveness by injecting GC3107 in 20 healthy adults.
The tuberculosis vaccines approved in Korea are six products, including Onco-TICE Injection by MSD Korea한국MSD, Hd-sol BCG Sol. by Green Cross Medical Science녹십자엠에스, BCG Vaccine SSI by Accesspharm엑세스파마, Dried BCG Vaccine by Korea Vaccine Corp.한국백신상사.
There are two types of tuberculosis vaccines -- an injectable vaccine and a patch vaccine. People get injection vaccine from the government free of charge. As Korea imports all tuberculosis vaccines, however, their supply has frequently been delayed and suspended. And the government has pushed for its localization to solve the supply shortage of BCG vaccine.
Green Cross began to localize tuberculosis vaccine in 2008 when the government consigned the national project to it. The company built a BCG production facility in Hwasun, South Jeolla Province, with the government funding of 8.7 billion won ($7.6 million) in 2011. In 2014, it made a contract with Korea Centers for Disease Control and Prevention (KCDC) 질병관리본부 to develop the BCG vaccines and received 1.95 billion won from it.
Green Cross completed non-clinical trial in 2016 and will develop the vaccines in earnest after the approval.
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