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 to fulfill the unmet medical need, especially focusing on the severe and no approved treatment of rare diseases such as epidermolysis bullosa simplex.

Product Pipelines

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Company Milestones

   2010 TWi Biotechnology Inc. was founded.
   2015 TWiB’s new drug AC-203 for treatment of Epidermolysis Bullosa, licensed to Castle Creek Pharmaceuticals, LLC for the global rights except Asia.
   2016 Listed in Taipei Exchange, stock code: 6610
   2017 First Patient Enrolled in pivotal study of AC-203 for treatment of Epidermolysis Bullosa Simplex.
   2018 AC-203 received US FDA Orphan Drug Designation、Rare Pediatric Disease Designation and Fast Track Designation.
   2019 First Patient Enrolled in Phase 2 POC Study of AC-701 for EGFRI-induced skin rash.
   2020 TWiB obtained the TWiP’s global authorization to develop Tofacitinib Citrate Topical Gel.
   2020 AC-1101 for treatment of vitiligo was approved by the U.S. FDA and Health Canada to enter Phase I human clinical trial.
   2020 TWiB received notice of patent allowance by USPTO for topical formulations comprising tofacitinib. (AC-1101)
   2020 TWiB entered exclusive agreement with Minophagen Pharmaceutical Co.,Ltd for rights to AC-203 in Japan.
   2021 TWiB entered exclusive agreement with Hong Kong Winhealth Pharma Group Co., Limited for rights to AC-203 in Mainland China, Hong Kong and Macau.
   2021 TWiB obtained the authorization from Shenzhen Salubris Pharmaceuticals Co., Ltd to expend Enarodustat (JTZ-951) market in Taiwan.
   2021 TWiB reported positive results from Phase I trial of AC-1101.