Milestone
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2023
- JUN
-
The cell therapy pilot plant started construction.
- MAR
-
Establishment of a Subsidiary in the U.S.
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2022
- SEP
-
Invest in Krisan Biotech Co., Ltd. to build a one-stop service platform for ADC. (Antibody Drug Conjugate)
- JUL
-
Awarded the Best CDMO of Taiwan Biopharma Excellence Awards 2022.
- JAN
-
GMP Plant 2 (Zhunan) commences operation.
-
2021
- AUG
-
Mycenax Biotech Inc. and Cytiva announced their partnership to enable Taiwan’s first continuous manufacturing process development satellite laboratory.
- JUN
-
Mycenax signs an MOU with CHO PHARMA . Mycenax will become the world's first contract development and manufacturing organization (CDMO) partner of CHO Pharma to provide commercialized manufacturing services.
- MAY
-
Mycenax becomes Taiwan’s first CDMO company to complete the CHO-S and CHOZN® GS Cell Line Development with the Beacon® Optofluidic System.
-
2020
- AUG
-
Initiated the construction of the second GMP facility.
-
Expanded production lines of mammalian and microbial cells.
- MAY
-
Initiated the development of manufacturing automation.
- APR
-
Signed the agreement with Gedeon Richter Plc. (one of the top 100 global pharmaceutical companies) for the sale of LusiNEX.
-
2019
- FEB
-
Acquired the CRO segment (originally TPG Biologics, Inc.) from Lumosa Therapeutics Co., Ltd.
- JAN
-
TuNEX was approved by the NHIA and covered by the National Health Insurance.
-
2018
- OCT
-
Business of CDMO services expands to Korea market.
- JAN
-
TuNex (ENIA11) is the first biological product which TFDA granted license approval.
-
2017
- MAY
-
Business of CDMO services expands to China market.
-
Fill/Finishing line was upgraded, and increased a new container cartridge aseptic line.
- MAR
-
Business of CDMO services expands to the US market.
-
2016
- NOV
-
Mycenax in-house MBICHO medium has been innovated for improving the competitive capacity of CDMO services.
- SEP
-
The third manufacturing line started to construct.
- MAR
-
Succeeded in unblinding phase III clinical trial of TuNEX (TW).
- JAN
-
Established the production line of 50L turbo (microbial).
-
2015
- OCT
-
Completed enrollment of 180 participants in phase III clinical trial of TuNEX (TW).
- JUN
-
Mycenax signed an agreement of contract manufacturing biologics with an Australian biopharma. Business of CDMO services expands to Australia market.
-
2014
- DEC
-
Development project of LusiNEX received grants from MEA.
- OCT
-
Mycenax signed an agreement of contract manufacturing biologics with Japanese biopharma. CDMO services expand to Japan market.
- APR
-
Completed construction of 2000L bioreactor as the first in Taiwan.
-
2013
- DEC
-
Mycenax Cooperate stock was officially listed on Stock Exchange at Dec. 25, 2013.
- NOV
-
Mycenax began the development project of LusiNEX.
- OCT
-
Mycenax received PIC/S GMP certificate from TFDA.
- SEP
-
TuNEX received a silver award of Pharmaceutical Technology Research and Development Award from TFDA.
- MAR
-
Mycenax signed an agreement of contract manufacturing biologics with European biopharma. CDMO services expanded to the EU market.
-
2012
- DEC
-
Mycenax partnered with TSH Biopharm, for TSH to be responsible for phase III clinical trial and NDA submission, and Mycenax was responsible for the manufacture of TuNEX.
-
Established 200/500L SUB (single-use bioreactors).
-
2011
- DEC
-
TFDA approved phase III clinical trial of TuNEX in Taiwan.
-
2010
-
Completed phase I/II clinical trials of TuNEX.
-
2009
- OCT
-
TuNEX received approval to enter phase III clinical trial from Korea FDA.
-
2008
- NOV
-
Mycenax received a bronze award of Taiwan Biotech industry Awards.
- OCT
-
Mycenax was registered as the listed company at the emerging stock market. Mycenax was categorized formally as biopharmaceutical company by MEA.
- AUG
-
Started to conduct the second tier of MEA Industrial TDP, from Aug. 2008 to March 2010.
-
2007
- NOV
-
TuNEX was approved to enter phase I/II clinical trial.
- APR
-
The development project of GranNEX started to conduct and was supported by MEA Industrial TDP.
-
2006
- APR
-
Issued the IPO (4726).
-
2005
- AUG
-
Mycenax conducted Follow-on Biologics project granted by MEA for TuNEX pre-clinical development from Aug. 2005 to Jul. 2007.
- JAN
-
Registered DMF to FDA (DMF no.17981)
-
2004
-
First pharmaceutical company in Taiwan to utilize single-use bioreactors; Introduced opinercept (TuNEX®) production cell line.
-
2003
- OCT
-
Completed construction of biologics plant in Jhunan Science Park.
-
2002
- MAY
-
Established and installed in Jhunan Science Park.
-
2001
- SEP
-
Myceanx was established in Xindian Dist., New Taipei City.