Milestones

 

2021

  • Positive results from Phase III clinical trial and applying for BLA

2020

  • Successfully developed COVID-19 rapid test kit with AEP alliance.

  • Approved facility from Japan PMDA

2019

  • Secured a global licensing deal with Sandoz for EG12014.
  • Zhubei facility officially operates.
  • IPO on TPEx (Code: 6589)

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 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.