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About PharmaEssentia

PharmaEssentia Corporation (Taipei Exchange:6446) is a fully integrated global biopharmaceutical company delivering efficacious, safe and cost-effective therapeutic products for the treatment of human diseases while aiming to bring long lasting value to stakeholders

PharmaEssentia was founded in 2003 by a group of Taiwanese-American executives and high-ranking scientists from leading U.S. biotechnology and pharmaceutical companies in order to develop treatments for myeloproliferative neoplasms, hepatitis and other diseases. The company is committed to the improvement of health and quality of life for patients suffering from these diseases.

 The Company’s world-class cGMP biologics facility in Taichung is certified by the Taiwan Food and Drug Administration (TFDA) and is designed and operated to be compliant with all U.S. FDA and EMA requirements.

 

Company History

2018

  • Jan PharmaEssentia Taipei Laboratory receives GMP Certificate approved by EMA.
  • Jan PharmaEssentia Taichung Plant receives GMP Certificate approved by TFDA and EMA.
  • May TGA permits the Phase I trial for P1101 in Japan.

2017

  • Mar AOP Orphan Pharmaceuticals AG announces start of EMA marketing authorization application procedure for Ropeginterferon alfa-2b in Polycythemia Vera.
  • Mar “MPN Asia” The 2nd Annual International Symposium on Myeloproliferative Neoplasms, hosted by JSH (Japanese Society of Hematology) and co-sponsored by and PharmaEssentia.
  • Apr Approval for KX01 Phase I clinical trial for Gastric, Gastro-esophageal, or Esophageal Cancers received from TFDA.
  • May Approval for compassionate Use of Ropeginterferon alfa-2b /P1101 for treatment of patients stably controlled on Pegasys received by USFDA.
  • Aug The topic “Ropeginterferon, Welcome to the US” presented by Dr. Srdan Verstovsek at US Focus on Myeloproliferative Neoplasms and Myelodysplastic Syndromes 2017.
  • Sep Ropeginterferon alfa-2b listed in Priority Review by CFDA.
  • Sep Pre-Approval Inspection (PAI) in PharmaEssentia Taichung Plant was given by EMA, and no critical observations occurred.

2016

  • Jan “MPN Asia” The 1st Annual International Symposium on Myeloproliferative Neoplasms, co-sponsored by the Hematology Society of Taiwan and PharmaEssentia.
  • Jul Publicly listed on Taipei Exchange in Taiwan on 19 July, 2017.

2015

  • Jan Received US FDA approval to conduct clinical trial of Ropeginterferon alfa-2b on primary myelofibrosis in the United States.
  • Mar Completed the recruitment of Phase III study of Ropeginterferon alfa-2b for the treatment of Polycythemia Vera (PV).
  • May Received TFDA approval to conduct Phase III clinical trial of Ropeginterferon alfa-2b for HCV-GT2.
  • May Submitted application of Investigational New Drug (IND) to TFDA in December 2014 after obtaining the licensing rights from Kinex Pharmaceuticals for development of new drug KX01 in Asian territories, and received approval on May 27, 2014.

2014

  • Mar Listed on the Emerging Stock Market.
  • Jul Received notice of IND acceptance from US FDA about Phase III trial of Ropeginterferon alfa-2b for PV with IND number 119047.