Enimmune announced that its Enterovirus 71 (EV71) vaccine, produced at its parent company ADIMMUNE’s Tanzi facility, has received approval from the Taiwan Food and Drug Administration (TFDA) for process scale-up, allowing each batch to be produced at more than three times the original volume. Enimmune’s EV71 vaccine, EnVAX-A71, is being developed in collaboration with Vietnam’s state-owned VABIOTECH, which submitted a new drug registration application to Vietnam on July 18, supported by the expanded production capacity.
Enimmune explained that, given the anticipated demand for EV71 vaccines in Southeast Asia, process scale-up was initiated last year at ADIMMUNE’s Tanzi cell factory. The scale-up involved transitioning from small-batch to large-batch production through three Process Performance Qualification (PPQ) batches and completing over six months of product stability testing. Comparative analysis confirmed that the quality of the scaled-up vaccine matches that of small-batch production. The process scale-up application was submitted in April and received TFDA approval by the end of August.
ADIMMUNE’s cell culture facility uses advanced bioreactor processes to manufacture EV71 vaccines, providing both stable quality and higher production capacity. The successful scale-up further validates the advantages of the bioreactor process. Enimmune CEO Chih-Wei Chang noted that, according to VABIOTECH, the Vietnamese government places high importance on vaccine supply capacity for epidemic prevention. The approved scale-up confirms that Enimmune’s production can meet Vietnam’s regulatory requirements, providing strong support for the vaccine’s entry into Southeast Asia.
EnVAX-A71, developed independently by Enimmune, was submitted for new drug registration to the Drug Administration of Vietnam (DAV) by VABIOTECH on July 18. With bioreactor production at ADIMMUNE’s Tanzi facility, annual output is secured at a minimum of one million doses, sufficient to meet both Taiwan and Vietnam’s public health needs while positioning for broader Southeast Asian market expansion.
Enimmune’s EV71 vaccine has completed Phase III multicenter clinical trials, showing a vaccine efficacy (VE) of 99.21%, meeting critical benchmarks for protective efficacy and immune durability. The company has begun GMP scale-up for 200- and 1,000-liter production to ensure adequate supply for the Vietnamese market, with further plans for expansion across Southeast Asia.
The global EV71 vaccine market is estimated at US$340 million in 2024, projected to grow to US$570 million by 2033 at a compound annual growth rate of 5.8%. If Vietnam incorporates the vaccine into its national immunization program, the market potential there is about US$40 million annually, with the ASEAN market expected to exceed US$300 million.
Resource: 安特羅腸病毒疫苗獲准製程放大，進軍東南亞最佳後盾
