UPDATE : Monday, August 10, 2020
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HOME Pharma
GC gets item license from regulator
  • By Shim Hyun-tai
  • Published 2020.03.04 17:21
  • Updated 2020.03.04 17:21
  • comments 0

GC Pharma said Wednesday that it has won the chickenpox vaccine Varicella shot’s item license from the Ministry of Food and Drug Safety.

Varicella injection went through an attenuation process like existing chickenpox vaccines but with improved quality and productivity. GC Pharma said it upgraded Varicella's production yield by improving productivity and upgraded its stability by increasing live virus content.

The company said Varicella had proved its efficacy and stability by demonstrating non-inferiority against contrast drug in phase 3 multinational clinical trials on children aged more than 12 months and less than 13 years in both Korea and Thailand.

GC said it is the only company in the world to produce chickenpox vaccine without antibiotics via a virus-free process system.

The company plans to advance to global chickenpox vaccine markets sized at about $2.3 billion. GC has exported its existing chickenpox vaccine Suduvax to Latin America, Asia, and elsewhere for 20 years. Suduvax has topped the bidding market of the Pan American Health Organization under the World Health Organization (WHO). The company is confident of its marketability if the quality is added to its global marketing network.

"We want to contribute to reducing social burdens and expenses resulting from chickenpox outbreaks on the globe with our upgraded vaccine, Varicella," said Lee Jae-woo, head of GC Pharma’s Development Headquarters. "In the future, we will target the global market after winning WHO's pre-qualification certificate along with the domestic supply."

shim531@docdocdoc.co.kr

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