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About Us

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

2021

  • Nov The marketing authorization for Ropeginterferon alfa-2b for treatment of Polycythemia Vera (PV) was granted by U.S FDA.
  • Sep The US FDA completed the GMP inspection of PharmaEssentia Taichung manufacturing site from September 20th to 28th, and no major concerns occurred of the inspection.

2020

  • Jun Panco Healthcare Co. Ltd. was merged by PharmaEssentia; Panco will be responsible for Besremi® commercialization in Taiwan.
  • May The marketing authorization for Ropeginterferon alfa-2b for treatment of Polycythemia Vera (PV) was granted by TFDA.
  • Mar US BLA filed.

2019

  • Feb The Marketing Authorization For Ropeginterferon alfa-2b was granted by EMA.

2018

  • Dec CHMP (The Committee for Medicinal Products for Human Use) Recommended Granting Marketing Authorization For Repeginterferon By MPN Research Foundation.
  • Dec PharmaEssentia Aseptic Filling & Package Plant Opening.
  • May TGA permits the Phase I trial for P1101 in Japan.
  • Jan PharmaEssentia Taipei Laboratory received GMP Certificate approved from EMA.
  • Jan PharmaEssentia Taichung manufacturing site received GMP Certificate approved from TFDA and EMA.

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.
  • Aug The topic “Ropeginterferon, Welcome to the US” presented by Dr. Srdan Verstovsek at US Focus on Myeloproliferative Neoplasms and Myelodysplastic Syndromes 2017.
  • May Approval for Compassionate Use of Ropeginterferon alfa-2b (P1101) for treatment of patients stably controlled on Pegasys received by US FDA.
  • Apr Approval for KX01 Phase I clinical trial for Gastric, Gastro-esophageal, or Esophageal Cancers received from TFDA.
  • 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.

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, 2016.