Milestones
2023
Approved facility from US FDA
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.