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Member Profile

In the field of protein drug design, the process of pegylation of the therapeutic protein preserves its biologic activity by targeting the PEG polymer (polyethylene glycol) at a specific and a defined region on the protein. PharmaEssentia’s pegylation technology platform is designed to increase the protein drug’s efficacy by prolonging its circulation in the blood stream. Utilizing its innovative 40K PEG and its novel pegylation technology platform by combining protein engineering and PEG-related chemistry, PharmaEssentia creates novel product- Ropeginterferon alfa-2b for better disease treatment. Compared with similar drugs on the market, the long-acting, mono-pegylated proline interferon with improved pharmacokinetic properties allowing once every two weeks administration offering improved tolerability and convenience. The marketing authorization for Ropeginterferon alfa-2b for treatment of Polycythemia Vera (PV) is granted by EMA in 2019 and Taiwan in May 2020.


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Company Milestones

   2017 PharmaEssentia approves EMA’s PAI (Pre-Approval Inspection) for PV.
   2018 The data of P1101 (Ropeginterferon alfa-2b) for PV in Phase III shows superiority in Durable Response for HU patients.
   2018 AOP, the partner of PharmaEssentia in EU, has submitted the D120 LoQ to EMA and is expected to obtain the approval at the end of 2018.
   2019 The Marketing Authorization For Ropeginterferon alfa-2b (Besremi) is granted by EMA.