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Member Profile

Established in June 2010, TWi Biotechnology focuses on the development of new drugs for innate immunity-related diseases, especially in the areas of rare and dermatological disorders. Leveraging its extensive experience in clinical, pre-clinical and pharmacology/toxicology studies, local and international regulations, and deep knowledge of global patent protection and business licensing, as well as track record of specialty drugs development in the US, TWi Biotechnology assumes a leading position in clinical research and drug development.
The mission of TWi Biotechnology is to fulfil the unmet medical needs, where effective or novel treatment is still not available, for example serious rare diseases. In addition, there is high demand for development of new treatments due to changes in disease management and breakthrough research in disease pathogenesis. In order to achieve innovation and to create value for the company rapidly, TWi Biotechnology has adopted a drug repositioning strategy with the aim to efficiently develop safe and effective new drugs for these patients.


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Company Milestones

   2010 TWi Biotechnology Inc. formed in Taiwan as the fully owned subsidiary of TWi Pharmaceuticals Inc., and acquired the IP assets of Anchen Lab from Anchen Inc.
   2012 Obtained US FDA IND approval for conducting a clinical trial of AC-201 for gout indication.
   2013 TFDA IND approval for conducting clinical trial of AC-701 for EGFRI-induced skin rash indication.
   2014 Obtained USFDA orphan drug designation for AC-203 for epidermolysis bullosa(EB) indication.
   2015 Obtained USFDA orphan drug designation for AC-203 for EB indication.
   2015 Obtained TFDA orphan drug designation for AC-203 for Epidermolysis bullosa (EB)
   2015 Entered into partnership with Castle Creek Pharmaceuticals, LLC.(CCP) USA to develop and commercialize AC-203 topical use for Epidermolysis Bullosa(EB) in worldwide except Asia.
   2016 AC-203 passed US IND.
   2016 Emerging exchange listing, stock code: 6610
   2017 Received CFDA CTA for AC-201CR clinical trial.
   2017 The first patient enrollment for AC-203 globe clinical trial.
   2018 AC-203 receives US FDA Rare Pediatric Disease Designation.
   2020 Obtained Canada Health Approval for AC-1101 Phase 1 CTA.
   2020 Obtained US FDA IND approval for conducting AC-1101 Phase 1 clinical trial.