Adimmune held a press conference where Chairman Chi-Shean Chan said that there will be progress on the three key vaccines next year. The quadrivalent influenza vaccine has been submitted to Brazil for regulatory approval and is expected to be approved in the fourth quarter of next year; the enterovirus vaccine phase III will be unblocked in the third quarter of next year at the earliest and the statistical data will be even more meaningful; and finally, the tetanus vaccine will be back in mass production and will be used in the Southeast Asian and China where there is a shortage of production capacity.
Influenza vaccine, according to Chan, this year has successfully completed the production of 3.5 million doses of publicly-funded influenza vaccine shipments, and sold to Eastern Europe, China and Thailand, and further filed application in Brazil in November this year.
Chan noted that in the past Adimmune's influenza vaccine production line was only supplied to the northern hemisphere, resulting in the plant being idle for six months. As a result, the company is expected to begin filing for regulatory approval in Brazil to expand production capacity throughout the year.
Chan said that in terms of tetanus vaccine, Taiwan's annual demand for 800,000 doses, is currently listed as one of the CDC shortage of drugs, but since the resumption of production of Adimmune on the market, the problem of drug shortage in hospitals has been approved, but because of the tetanus vaccine anaerobic environment, the threshold of a single production line is relatively high, resulting in the Southeast Asian countries and China are also facing shortage of supply.
Adimmune added that China's recent announcement that rabies vaccination is mandatory for standard medical treatment of dog bites, coupled with tetanus vaccine, has led to a widening gap in the tetanus vaccine market: the current annual demand for tetanus vaccine in China is 60 million doses, but there are only two manufacturers in China producing the vaccine, which is clearly insufficient capacity.
As the new Adimmune tetanus vaccine plant complies with PIC/S GMP and U.S. FDA standards, with an annual production capacity of at least 5 million doses, and in response to the needs of medical personnel, Adimmune has developed a single-dose injection tetanus vaccine, which can shorten the vial-opening and extraction steps, making it more convenient to be used by emergency physicians and clinicians, and supplying a large amount of production capacity in Taiwan for export, it is expected that sales of tetanus vaccine will grow significantly next year.
As for the enterovirus vaccine part, Adimmune's General Manager Vic Chang said that Adimmune's production capacity in the Zhunan plant is limited, and this year's output is only 1~15,000 doses. However, Adimmune has already initiated the conversion of the enterovirus vaccine production line and applied for a factory inspection by the TFDA, and it is expected that in the fourth quarter of next year, the enterovirus vaccine production line will be able to move back to Adimmune's Tamzi cell culture facility, which will result in a multiple increase in production capacity.
Vic Chang noted that the phase III clinical trial of Enimmune's enterovirus vaccine in Vietnam is progressing well, with 2,470 participants recruited, and an efficacy evaluation report is expected by the third quarter of next year. Although only 12 efficacy investigators were originally required, there are now 70, and the larger the statistics, the greater the value of the vaccine's true significance.
Based on past CDMO performance and on-site inspection experience in the EU, Canada and Brazil, Adimmune has established a reputation with international OEMs and has attracted new OEM collaborations, with well-known Korean and French manufacturers currently in discussion for new OEM business to be confirmed in the first quarter of next year.
Following a strategic partnership with BD, a major international syringe manufacturer, and the signing of a strategic alliance with WEGO, an international medical device manufacturer, Adimmune will initially promote sales of Influenza, Tetanus and Enterovirus vaccines in Southeast Asia and will consider further collaborations for the establishment of factories in Southeast Asia in the future to achieve the goal of internationalisation.
