Adimmune (國光生技) subsidiary Enimmune (安特羅) announced on the 14th that its EnVAX-A71 (Enterovirus 71 vaccine), produced at the Tanzi cell culture plant, has officially received Vietnam GMP certification. The approval was published by the Drug Administration of Vietnam (DAV).

Market Expansion & Production:

• Regulatory Gateway: Following its Thailand GMP achievement, the Vietnam certification is a prerequisite for a New Drug Application (NDA). General Manager Jerry Chang expressed optimism regarding the imminent approval of the vaccine in Vietnam.
• Clinical Performance: The vaccine completed a multi-center Phase III trial in Vietnam, demonstrating a Vaccine Efficacy (VE) of 99.21% with high immune persistence.
• Capacity: Adimmune’s high-specification bioreactor-based cell culture facility is prepared to supply over 1 million doses annually to the Taiwan and Southeast Asian markets. Applications are also currently pending in Macau and Thailand.

Resource: 安特羅疫苗獲越南認證