2026-
2026
- TWiB announced the results of interim analysis on the EBShield Study on February 4, 2026.
2025-2021
2025
- TWiB completed the merger with Dukang Pharmaceuticals, Inc. on September 30, 2025.
2024
- First Patient Enrolled for the EBShield Study, an international, multicenter, randomized, double-blind, vehicle-controlled, Phase 2/3 study with open-label extension study on AC-203 for the treatment of EBS.
- TWiB concluded the US Phase 1b trial of AC-1101 for GA with satisfactory results, demonstrating favorable safety, tolerability, and PK profiles, alongside a preliminary therapeutic trend.
2023
- TWiB received approval from the US FDA to conduct a Phase 2/3 clinical trial on AC-203 for the treatment of EBS.
2022
- TWiB completed End-of-Phase 2 (EOP2) meeting with US FDA for the continuing development of AC-203 in treating EBS.
- TWiB completed a scientific consultation meeting with the European Medicines Agency (“EMA”) for the development of AC-203 in treating EBS.
- TWiB received an IND approval from US FDA on AC-1101 for the treatment of granuloma annulare (“GA”).
- TWiB initiated a Phase 1b trial on AC-1101 in treating GA in the U.S.
2021
- TWiB terminated the exclusive licensing agreement on the global (excluding Asia) rights of AC-203 with CCP, which had been renamed as Castle Creek Biosicences, Inc.
- TWiB completed Phase 1 pharmacokinetics (PK) and safety study for AC-1101 on healthy subjects in Canada, showing satisfactory safety and tolerability results.
2020-2016
2020
- TWiB signed an exclusive license agreement with TWi Pharmaceuticals, Inc. for the in-licensing of all rights in connection with AC-1101, a topical gel of Tofacitinib Citrate (a Janus Kinase inhibitor).
- TWiB received approval from Health Canada for the Phase 1 Clinical Trial Application on AC-1101.
- TWiB obtained an Investigational New Drug (“IND”) approval from US FDA on AC-1101 in treating vitiligo.
2018
- US FDA granted Rare Pediatric Disease Designation for AC-203 in the treatment of EBS.
- TWiB received Fast Track Designation from US FDA for AC-203 in treating EBS.
- CCP discontinued the DELIVERS Study due to unsatisfactory interim analysis results.
2017
- First Patient Enrolled in DELIVERS Study, a double-blind, placebo-controlled, international Phase 2 clinical trial conducted and sponsored by CCP, on AC-203 in treating EBS.
2016
- TWiB was listed as an Emerging Company in Taiwan's GreTai Securities Market (6610.TWO).
2015-2011
2015
- TWiB obtained Orphan Drug Designation from Taiwan Food and Drug Administration (“TFDA”) for AC-203 in treating EBS.
- TWiB entered into an exclusive license agreement with Castle Creek Pharmaceuticals, LLC., a US-based biopharmaceutical company, for the global rights (excluding Asia) to develop and commercialize AC-203 for the treatment of EBS.
2014
- TWiB obtained Orphan Drug Designation from US Food and Drug Administration (“US FDA”) for AC-203, a diacerein 1% ointment, in the treatment of epidermolysis bullosa simplex (“EBS”), a rare genetic skin disease caused by genetic mutation, resulting in fragile epidermal cells that lead to blisters and ulcers.
2010-2006
2010
- Anchen Lab was spun off from Anchen Inc. as TWi Pharmaceuticals, Inc., which later became Taiwan’s leading manufacturer of high entry-barrier generic drugs for the U.S. market ;
- TWi Biotechnology, Inc.(“TWiB”) was spun off from TWi Pharmaceuticals, Inc. as a wholly owned subsidiary to engage in the development of repurposed new drugs.
2006
- Anchen Lab was established in Taiwan as a research & development center of Anchen Inc. set up in Taiwan.
2005-2001
2002
- Dr. Chih-Ming Chen, our founder and controlling shareholder, founded Anchen Pharmaceuticals, Inc. (“Anchen Inc.”) as a specialty pharmaceutical company, in Irvine, California.