Milestone

2018

2017

2016

2015

2014

2013

2011

2008

2006

2005

2018
  • Received the "Asia's Best CMO" awarded by Biologics Manufacturing Asia (BMA).
  • EG12014 was approved for phase III clinical trial by US FDA and Taiwan FDA.
2017
  • Held beam-raising ceremony for Zhubei plant
  • Received "2017 Biomarker Industry Potential Benchmark Award" by Taiwan Bio Industry Organization
  • EG12014 European Phase I clinical trial study showed positive results.
  • Received "Grand Winner of Best Bioprocess Excellence in Taiwan” by Biologics Manufacturing Asia (BMA)
  • Antibody Drug Conjugate platform received excellence award by Biologics Manufacturing Asia (BMA)
  • Received official certificate from Japan MHLW of foreign manufacturer of biologics, which granted biologics manufactured by EirGenix in Taiwan.
2016
  • EG12014 was approved for the European Phase I clinical trial.
  • Received financial support around NT$850 million for Zhubei plant
  • Began Zhubei plant’s construction
  • EirGenix cooperate stock was officially listed on Stock Exchange (6589).
2015
  • Completed follow-up inspection by Taiwan FDA
  • Applied EG12014 for the European Phase I clinical trial.
  • Received the Gold Prize for in "Biomedical and New Agricultural Industry Award".
2014
  • EirGenix's received PIC/S GMP certificate from Taiwan FDA.
2013
  • Predecessor's (DCB-Biopharmaceutical Pilot Plant) microbial production facility received cGMP certificate from Taiwan FDA.
  • Acquired DCB-biopharmaceutical pilot plant.
  • Updated the US FDA Type V Drug Master File and Taiwan FDA registration information.
  • Completed follow-up inspection by the Taiwan FDA
2012
  • EirGenix Inc. was founded.
2011
  • Predecessor (DCB-Biopharmaceutical Pilot Plant) received BioPharm 2011 Asia Best CMO Award.
  • Predecessor (DCB-Biopharmaceutical Pilot Plant) completed follow-up inspection by Taiwan FDA.
2008
  • Predecessor (DCB-Biopharmaceutical Pilot Plant) completed follow-up inspection by Taiwan FDA.
2006
  • Predecessor (DCB-Biopharmaceutical Pilot Plant) registered Drug Master File to US FDA (DMF no. 19164).
    NOTE: Type V DMF is used for sterile manufacturing plants and contract facilities for biotech products.
2005
  • Predecessor (DCB-Biopharmaceutical Pilot Plant) received cGMP certificate from Taiwan FDA.