Enimmune Corp. (TPEx: 6564), an Adimmune Corporation’s subsidiary, announced yesterday through a material information disclosure that it has obtained Vietnam GMP certification for its Enterovirus 71 (EV71) vaccine, EnVAX-A71, which is manufactured at Adimmune’s Tanzi Cell Culture Plant. The certification has been officially published on the website of the Drug Administration of Vietnam (DAV) and Adimmune (TWSE: 4142) is included in the list of GMP-compliant foreign manufacturing facilities.   

As GMP certification is regarded as a prerequisite for marketing authorization, this approval marks a significant milestone toward regulatory approval in Vietnam as well as underscores Adimmune’s proven capability in advanced bioreactor-based manufacturing processes that ensure stable large-scale production capacity and consistent product quality.   

The GMP application for the enterovirus vaccine in Vietnam was submitted in late May 2025 through Enimmune’s local partner, VABIOTECH, to the DAV. The application was formally received by DAV on June 5, and the results of the overseas manufacturing facility GMP compliance assessment were announced in Official Letter No. 140/QLD-CL, issued on January 12 this year. As a result, Adimmune’s Tanzi Cell Culture Plant, which produces Enimmune’s enterovirus vaccine, was granted Vietnam GMP certification.   

Adimmune has made substantial investments to build a high-specification cell culture manufacturing facility utilizing advanced bioreactor technology. Since obtaining Taiwan FDA GMP certification in June 2022, the facility received Thailand GMP certification in 2025 and Vietnam GMP certification in early 2026. These achievements demonstrate that Adimmune’s bioreactor-based manufacturing technology has successfully surpassed key technical thresholds, reinforcing confidence in supplying at least one million doses annually to Taiwan and Southeast Asian markets with stable quality.   

Enimmune President Vic Chang stated that the successive acquisition of GMP certifications across multiple countries has significantly strengthened the company’s strategic positioning in Southeast Asia. He noted that Enimmune’s EV71 vaccine, independently developed and manufactured in Taiwan, has completed a Phase III multicenter clinical trial in Vietnam, with results showing a vaccine efficacy (VE) of 99.21%, meeting critical benchmarks for protective efficacy and immune durability. Enimmune has already submitted marketing authorization applications in Vietnam, Macau, and Thailand, and expects to see tangible progress within the year. To further expand its presence in Southeast Asia, the company continues to seek strategic partners in Indonesia, Malaysia, and other countries, accelerating public health initiatives related to enterovirus prevention.   

Enimmune further explained that over the past decade, the incidence of hand, foot, and mouth disease (HFMD) has shown an upward trend worldwide, particularly in Asia-Pacific regions such as Mainland China, Japan, Singapore, and Vietnam. According to World Health Organization (WHO) data, Vietnam reports approximately 50,000 to 100,000 HFMD cases annually, including several fatal cases. Other studies indicate an average of around 80,000 cases per year in recent years, while no EV71 vaccine is currently commercially available in Vietnam.   

The global enterovirus vaccine market was valued at approximately USD 340 million in 2024 and is projected to grow to USD 570 million by 2033, representing a compound annual growth rate (CAGR) of approximately 5.8%. If Vietnam incorporates the vaccine into its national immunization program, the annual market value could reach approximately USD 40 million, with the total ASEAN market expected to exceed USD 300 million.   

Given that enterovirus has been prevalent in Southeast Asia for more than two decades—particularly EV71, which is associated with a higher rate of severe complications affecting children—Enimmune has prioritized Vietnam, Thailand, Malaysia, and Indonesia as key high-risk markets. The company aims to effectively reduce disease burden and meet regional public health needs through proactive vaccine deployment.