About

Founded in 1965, Adimmune is the first in Taiwan to comply with GMP standards of the FDA and the EU

History

The Cell Culture Production Plant received Taiwan Food and Drug Administration (FDA) PIC/S GMP certificate in 2022.

0
2020s
2020s

2023

  • EnVAX-A71, developed by Enimmune, was granted Marketing Authorization in Taiwan

2022

  • The Cell Culture Plant received Taiwan Food and Drug Administration (FDA) PIC/S GMP certificate
  • AdimFlu-S (QIS), quadrivalent influenza vaccine, received marketing authorization in China

2021

  • Adimmune signed a memorandum of understanding with Becton Dickinson

In January 2020, Adimmune extended the partnership with Sanofi Pasteur untill 2027

1
2015-2020
2015-2020

2020

  • Extension of partnership with Sanofi Pasteur untill 2027
  • Enimmune’s rapid test kits for COVID-19 received European CE Marking for In Vitro Diagnostic certificate

2019

  • AdimFlu-S (QIS), quadrivalent influenza vaccine, received marketing authorization in Thailand

2017

  • The Fill and Finish Plant received the Brazilian PIC/S GMP certificate
  • AdimFlu-S (QIS), quadrivalent influenza vaccine, received marketing authorization in Taiwan

2016

  • The Fill and Finish Plant received the U.S. FDA PIC/S GMP certificate

Adimmune signed a Cooperation Framework Agreement with Kitasato Daiichi Sankyo Co. in September 2015.

2
2010-2015
2010-2015

2015

  • Adimmune signed a Cooperation Framework Agreement with Kitasato Daiichi Sankyo Co., Ltd.
  • The Fill and Finish Plant received the EU GMP certificate
  • AdimFlu-S (TIS), trivalent influenza vaccine, received marketing authorization in China
  • Adimmune received Taiwan FDA validation for GDP standard of excellent pharmaceutical transportation

2014

  • Enimmune Corporation was established as a subsidiary of Adimmune
  • The Flu Antigen Production Plant and the Fill and Finish Plant received Taiwan FDA PIC/S GMP certificate
  • Adimmune partnered with Sanofi Pasteur in providing aseptic fill and finish services
  • Adimmune was awarded the Talent Quality-Management System Review Copper Award from the Taiwan Workforce Development Agency

2013

  • Licensure of Phase I clinical trial of enterovirus 71 vaccines between the National Health Research Institute and Adimmune was launched
  • Adimmune partnered with Techdow Pharm Co., Ltd. for a sterile filling service
  • Adimmune cooperated with UMN, a global leader in recombinant protein vaccine manufacturing

2012

  • The aseptic pre-filled syringe line received the Taiwan FDA PIC/S GMP certificate

2011

  • Adimmune was awarded the National Biotech-Medical Quality Gold Award
  • The Flu Antigen Production Plant received the EU GMP certificate

In June 2009, Adimmune inaugurated the Flu Antigen Production Plant.

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2005-2010
2005-2010

2010

  • Adimmune was awarded the Merit Medal Award from Executive Yuan for pandemic control of H1N1
  • The Deloitte Asia-Pacific High-Tech High-Growth Evaluation ranked Adimmune as the 8th in Taiwan, 64th in the Asia-Pacific region

2009

  • Under the New Biotechnology Ordinance, Adimmune was certificated as a biotechnology company by the Ministry of Economic Affairs
  • Adimmune inaugurated the Flu Antigen Production Plant

2008

  • The Japanese Encephalitis DNA vaccine received Taiwan patent

2007

  • Crucell B.V. (The Netherlands) became a strategic stakeholder

The ground-breaking ceremony of the Flu Antigen Production Plant in 2002.

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2000-2005
2000-2005

2005

  • Adimmune signed a technology transfer agreement with Kitasato Institute
  • Received the “Sullivan & Frost Award for Growth Strategy”
  • Received the grant from Ministry of Economic Affairs for “Industrial Technology Development Plan for Cell Culture Process Platform of Japanese Encephalitis Vaccine”

2002

  • Licensure of the human biological agent manufacturing technology between Taiwan Centers for Disease Control and Adimmune was launched
  • Construction of the Flu Antigen Production Plant began

2001

  • The name of the company was changed to “Adimmune Corporation”

In 1965, “Kuo Kwang Serum and Vaccine Manufacture Co., Ltd.” was founded in Shulin Township, Taipei County

5
1960s-1990s
1960s-1990s

1998

  • Received the Ministry of Economic Affair’s “Industrial Technology Development Plan for Production of Japanese Encephalitis Vaccine by Cell Culture Process” grant (Early stage)
  • Received “the 8th Annual Award for Biotechnology Industry Development” by Taiwan Bio Industry Organization

1967

  • Kuo Kwang signed official technical support and import/export agreement with Kitasato Institute

1965

  • “Kuo Kwang Serum and Vaccine Manufacture Co., Ltd.” was founded in Shulin Township, Taipei County