Adimmune Corp (國光生技) has an upbeat outlook for its flu vaccine business next year, chairman Steve Chan (詹啟賢) told a media briefing in Taipei yesterday.
The company expects to obtain marketing approval from the Chinese regulator for its quadrivalent flu vaccine in the first quarter of next year, with more approvals likely from regulators in Jordan and Pakistan later in the year, Chan said.
An application for market approval typically takes 12 to 18 months in those countries, Adimmune said.
Chan said he expects the company to receive orders for 5 million doses from China, which is a large market for flu vaccines.
Adimmune aims to expand in Russia by supplying more of the substance used in its quadrivalent flu vaccine to local biopharmaceutical company NPO Petrovax Pharm LLC, Chan said.
Adimmune is also preparing an application for market approval in Mexico, which would be its first market in South America, he said.
While the WHO recommends a different composition for influenza vaccines used in the northern hemisphere than for those used in the southern hemisphere, Adimmune, whose vaccines are currently only used in the north, is confident that it could produce vaccines for the south, as it would only involve adjusting the strain, Chan said.
Chan also told reporters that the company has begun recruiting participants in Indonesia for phase 2 clinical trials of a COVID-19 vaccine candidate.
Participants would receive a first vaccine dose next month and an interim analysis could be conducted in June next year, Chan added.
If the phase 2 human trials proceed smoothly, the company would apply to conduct phase three clinical trials in Indonesia, which would involve recruiting 30,000 participants and might cost NT$2 billion (US$71.84 million), Chan said.
Some conglomerates in Southeast Asia have shown interest in investing in the project, he added.
Adimmune said it would not seek emergency use authorization for the vaccine, but would instead apply for marketing approval.
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