Le Lézard
Classified in: Health, Science and technology, Business
Subject: FDA

Adimmune's Quadrivalent Flu Vaccine Approved by TFDA


TAIPEI, Taiwan, May 10, 2017 /PRNewswire/ -- Taiwan-based vaccine provider Adimmune (4142.TT) successfully obtained approval of its quadrivalent flu vaccine (ADIMFLU-S(QIS)) from Taiwan FDA. Adimmune will start the commercial production of quadrivalent flu vaccine in 2017 and supply the domestic out-of-pocket flu vaccine market. ADIMFLU-S(QIS) will provide superior protection and the company expects that the Taiwan government will subsequently begin procurement of quadrivalent flu vaccine for its annual vaccination plan.

Quadrivalent flu vaccine will provide more comprehensive protection, by including an additional strain of influenza B virus, compared with trivalent flu vaccine (designed to protect against three different flu viruses; two influenza A viruses and one influenza B virus). It is expected to replace trivalent flu vaccine and become the predominant product in the flu vaccine market. Adimmune sold over 3 million doses of trivalent flu vaccine in Taiwan in 2016.

ADIMFLU-S(QIS) also completed its 3,000 subject Phase III clinical trial in Europe and Adimmune is planning to begin marketing in Europe once approval is obtained in 2018.

Adimmune is also planning to kick off its ADIMFLU-S(QIS) clinical trial in China after TFDA's approval, and launch marketing campaigns once the China approval is obtained. Currently Adimmune's trivalent flu vaccine is approved by China FDA and has obtained market access to over 16 province/cities. ADIMFLU-S(QIS) will also be a key product to penetrate other emerging markets.

Adimmune's 2016 revenue was up 109% and 3-month revenue for 2017 was up 67% YoY. The strong growth is on the back of its new business line of the aseptic prefilled syringe of Enoxaparin Sodium shipping to Europe.

About Adimmune: Adimmune is the No.1 flu vaccine provider in Asia to obtain Taiwan, US, EU, and China cGMP. The Company has ample capacity in flu vaccine of 25mn doses/year and pre-filled syringe (PFS) of 25mn doses/year. Its solid capability in high-quality commercial scale human vaccine manufacturing has enabled Adimmune to expand its business to China, Europe and the US. Currently Adimmune is the largest provider of trivalent flu vaccine and sole provider of Tetanus vaccine and Bacillus Calmette-Guerin Vaccine in Taiwan. Adimmune is listed on the Taiwan Stock Exchange (4142 TT). For more information, please visit http://www.adimmune.com.tw or contact Peter Pan at [email protected].

SOURCE Adimmune


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