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Mycenax Biotech Inc.




Chairman
  • LIN RONG JIN
Date Established
  • 2001/09/28
TWSE Stock ID
  • 4726
Market Valuation
  • USD  146,000,000.0
Phone Number
  • +886-37-58-6988
Address
  • 4F., No.50-7, Keyan Rd., Zhunan Township, Miaoli County 350, Taiwan 35053
Website Theraputic Fields
  • Immunology
  • Oncology
Product Classification
  • Biologics
  • Biosimilars
  • Technology Platform
Top Products
  1. TuNEX®
  2. CDMO services

Mycenax Biotech Inc. (MBI), the CMC-based biopharmaceutical company, was established in 2001. In addition to offering process development and manufacturing services to clients, we focus on bionovel and biosimilar development. MBI featured in utilizing the most advanced single-use technology in its USFDA DMF registered and TFDA PIC/S GMP certified biomanufacturing facility, and conducting microbial fermentation and cell culture in 50L fermenter and 2,000 L bioreactor, respectively.
We support clients with cell clone construction, process development, formulation and aseptic fill/finishing, GMP manufacturing, analytical method development, and characterization. Based on its advanced infrastructure and experience, MBI provides high quality, cost-effective, time-efficient and international quality service for developing and manufacturing cGMP drug substance and finished product. As to in-house pipeline, TuNEX® is the first product launched in early 2018 in Taiwan. So far it is in discussion with foreign companies for overseas development and marketing. LusiNEX (tocilizumab; Actemra®-similar) is finished phase I study and will be start the phase III study at 2019 Q4. In the meantime, MBI also embarks on the development of bionovels and is keen to collaborate with co-developer or marketing and sales partner for regional or global development.

Product Pipelines

Please move your mouse cursor over abbreviations with periods to see their full names.

Company Milestones

   2005 Registration of USFDA Drug Master File (DMF) for biomanufacturing facility (DMF number 17981)
   2007 TuNEX phase I/II IND approved by TFDA.
   2011 TuNEX phase III IND approved by TFDA.
   2013 Agreement with European pharmaceutical company for the development of biologics.
   2013 As the contract service provider, MBI debuted in Europe.
   2013 Initiation of the LusiNEX development project.
   2013 IPO in Taiwan GreTai Securities Market.
   2013 MBI was inspected and certified CGMP by TFDA as per PIC/S GMP guidelines.
   2014 First 2,000L mammalian cell bioreactor in Taiwan was implemented in MBI’s biomanufacturing facility.
   2014 Agreement with Japanese pharmaceutical company for the development of biologics.
   2014 As the contract service provider, MBI debuted in Japan.
   2015 Agreement with Australian pharmaceutical company for the development of biologics.
   2015 As the contract service provider, MBI debuted in Australia.
   2017 The new drug application of TuNEX approved by TFDA.
   2018 TuNEX (ENIA11) acquired the new drug application (NDA) approved and obtained a drug license from the Food and Drug Administration of the MOHW of Taiwan and will be produced and sold in Taiwan.
   2018 Acquired the Accreditation certificate of foreign drug manufacturer issued by the Ministry of Health and Welfare of Japan, and the category identified is “Biological products of pharmaceutical biology”.