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Milestone

Milestone

  • 2023

    • JUN

    • The cell therapy pilot plant started construction.

    • MAR

    • Establishment of a Subsidiary in the U.S.

  • 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.

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