History

Ropeginterferon alfa-2b was approved for treatment of PV in Malaysia and China.

Ropeginterferon alfa-2b was approved for treatment of PV in Singapore.

Publicly listed of stock in Taiwan on 25 Jan, 2024.

Ropeginterferon alfa-2b was approved for treatment of PV in Japan.

PharmaEssentia hold the groundbreaking ceremony of the Zhubei plant.

PharmaEssentia honored at the National Organization of Rare Disorders (NORD®) 2022 Rare Impact Awards for the introduction of BESREMI® (ROPEGINTERFERON ALFA-2B-NJFT) for Polycythemia Vera.

Ropeginterferon alfa-2b was included in the U.S. NCCN Guidelines as a recommended therapeutic option for both high-risk and low-risk adult with PV, regardless of their previous therapies.

The marketing authorization for Ropeginterferon alfa-2b for treatment of Polycythemia Vera (PV) was granted by U.S FDA.

The marketing authorization for Ropeginterferon alfa-2b for treatment of Polycythemia Vera (PV) was granted by U.S FDA.

Ropeginterferon alfa-2b was approved for treatment of PV in Korea.

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.

Ropeginterferon alfa-2b was approved for treatment of PV in Israel.

The pivotal Phase III clinical trial of Ropeg vs. Anagrelide in Essential Thrombocythemia (ET) patients (SURPASS ET) started.

Ropeginterferon alfa-2b was approved for treatment of PV in Switzerland.

Panco Healthcare Co. Ltd. was merged by PharmaEssentia; Panco will be responsible for Besremi® commercialization in Taiwan.

The marketing authorization for Ropeginterferon alfa-2b for treatment of Polycythemia Vera (PV) was granted by TFDA.

US BLA filed.

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

CHMP (The Committee for Medicinal Products for Human Use) Recommended Granting Marketing Authorization For Repeginterferon By MPN Research Foundation.

PharmaEssentia Aseptic Filling & Package Plant Opening.

TGA permits the Phase I trial for P1101 in Japan.

PharmaEssentia Taipei Laboratory received GMP Certificate approved from EMA.

PharmaEssentia Taichung manufacturing site received GMP Certificate approved from TFDA and EMA.

Ropeginterferon alfa-2b listed in Priority Review by CFDA.

Pre-Approval Inspection (PAI) in PharmaEssentia Taichung Plant was given by EMA, and no critical observations occurred.

The topic “Ropeginterferon, Welcome to the US” presented by Dr. Srdan Verstovsek at US Focus on Myeloproliferative Neoplasms and Myelodysplastic Syndromes 2017.

Approval for Compassionate Use of Ropeginterferon alfa-2b (P1101) for treatment of patients stably controlled on Pegasys received by US FDA.

Approval for KX01 Phase I clinical trial for Gastric, Gastro-esophageal, or Esophageal Cancers received from TFDA.

AOP Orphan Pharmaceuticals AG announces start of EMA marketing authorization application procedure for Ropeginterferon alfa-2b in Polycythemia Vera.

“MPN Asia” The 2nd Annual International Symposium on Myeloproliferative Neoplasms, hosted by JSH (Japanese Society of Hematology) and co-sponsored by and PharmaEssentia.

Publicly listed on Taipei Exchange in Taiwan on 19 July, 2016.

“MPN Asia” The 1st Annual International Symposium on Myeloproliferative Neoplasms, co-sponsored by the Hematology Society of Taiwan and PharmaEssentia.

Received TFDA approval to conduct Phase III clinical trial of Ropeginterferon alfa-2b for HCV-GT2.

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.

Completed the recruitment of Phase III study of Ropeginterferon alfa-2b for the treatment of Polycythemia Vera (PV) in Europe.

Received US FDA approval to conduct clinical trial of Ropeginterferon alfa-2b on primary myelofibrosis in the United States.

Received notice of IND acceptance from US FDA about Phase III trial of Ropeginterferon alfa-2b for PV with IND number 119047.

Listed on the Emerging Stock Market.

Listed as a public company.

Received Certificate of Good Manufacturing Practice for Ropeginterferon alfa-2b (P1101).

Phase II 1-year-data from AOP2014/ropeginterferon alfa-2b PV clinical trials presented by AOP at The 54th America Society of Hematology (ASH) Annual Meeting and Exposition.

Production plant for protein new drugs at Central Taiwan Science Park opened.

Approval for Ropeginterferon alfa-2b Phase I/II clinical trial for hepatitis B treatment received from TFDA.

Completed plant construction for protein new drugs manufacturing at Central Taiwan Science Park.

Application for approval to conduct Ropeginterferon alfa-2b Phase I/II clinical trial of Hepatitis B treatment submitted to TFDA.

Approval for Ropeginterferon alfa-2b HCV-GT2 Phase II clinical trial received from TFDA.

Ropeginterferon alfa-2b received Orphan Drug Designation from US FDA.

Application for approval to conduct Ropeginterferon alfa-2b Phase II clinical trial for hepatitis C, Genotype II treatment submitted to TFDA.

Chinese patent for 'Ropeginterferon alfa-2b Polymer conjugates' issued (patent number:ZL200680053048.2)

AOP presented Phase I/II 6-month-data of AOP2014/ Ropeginterferon alfa-2b for Polycythemia Vera at the 53rd America Society of Hematology (ASH) Annual Meeting and Exposition.

KX01 compound for psoriasis is in-licensed from Kinex Pharmaceuticals

US patent for " Ropeginterferon alfa-2b N-terminal modified interferon alpha" issued (patent number: US 8,106,160).

Orphan Drug Designation received from EMA for AOP2014/ Ropeginterferon alfa-2b for the treatment of Polycythemia Vera (PV).

US patent for "Ropeginterferon alfa-2b Protein-Polymer Conjugates" issued (patent number: US 8,143,214).

Enrolls first patient in Phase II trial for Ropeginterferon alfa-2b hepatitis C, Genotype I treatment.

Ropeginterferon alfa-2b G1-HCV Phase II clinical trial approval received from FDA.

Application for approval to conduct Ropeginterferon alfa-2b Phase II clinical trial for treatment of hepatitis C, Genotype I submitted to TFDA.

Application for approval to conduct Ropeginterferon alfa-2b Phase II clinical trial for treatment of hepatitis C, genotype I submitted to FDA.

The drug license of Gemcitabine API received from TFDA.

The results of Phase I trial demonstrated Ropeginterferon alfa-2b is a much more stable product with fewer side effects than Pegasys.

Filed a DMF (No.24278) for Gemcitabine API at US FDA.

Phase I trial of Ropeginterferon alfa-2b completed.

Ropeginterferon alfa-2b formally began testing in humans.

Initiated "1st in human" Phase I clinical trial of Ropeginterferon alfa-2b with Anapharm Inc. of Canada.

Company's SBIR2+ project for Gemcitabine GMP production receives NTD5.2 million grant from the DOIT, Ministry of Economic Affairs.

Company's SBIR2+ project for PEG-P-Inf-β receives NTD2.6 million grant from the DOIT, Ministry of Economic Affairs.

Out-licenses Ropeginterferon alfa-2b (P1101) to AOP Orphan Pharmaceutical (AOP) of Austria for the treatment of Polycythemia Vera (PV), Essential Thrombocythemia (ET), Myeloid Fibrosis (MF) and Chronic Myeloid Leukemia (CML).

Ropeginterferon alfa-2b Phase I clinical trial for the treatment of hepatitis C approved by BGTD in Canada.

Ropeginterferon alfa-2b Phase I clinical trial for the treatment of hepatitis C approved by FDA.

Ropeginterferon alfa-2b (P1101) Phase I clinical trial for the treatment of hepatitis C approved by Taiwan's drug regulatory authorities.

Export license of Gemcitabine API received by Taiwan's Department of Health (DOH).

US patent of 'Stereoselective synthesis of β-nucleosides of Gemcitabine' granted (patent number: US 7,485,716).

US patent of 'Stereoselective synthesis of β-nucleosides of Gemcitabine' granted (patent number: US 7,485,716).

PharmaEssentia's second SBIR2 project received NTD4 million grant from DOIT, Ministry of Economic Affairs, for next generation PEG-IFN drug development.

Filed international patents for PharmaEssentia's next-generation PEG-IFN drugs and the corresponding synthetic manufacturing method.