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Bio B2BPharmaEssentia Corp. 〉Pegylation Platform

Pegylation Platform

Pegylation Platform

The process of pegylation of the therapeutic protein preserves its biological activity by targeting the PEG polymer (polyethylene glycol) at a specific and defined region on the protein.

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Overview
Core Technology: Pegylation Platform
In the field of protein drug design, the process of pegylation of the therapeutic protein preserves its biological activity by targeting the PEG polymer (polyethylene glycol) at a specific and 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 bloodstream. Utilizing its innovative 40K PEG and its novel pegylation technology platform by combining protein engineering and PEG-related chemistry, PharmaEssentia creates novel products for better disease treatment. Compared with the similar drugs on the market, the long-acting protein drugs produced by the technology possess the most effective PK/PD data as well as reduced side effects, as these PEG-proteins are designed as predominantly single forms without other isomers which may induce severe side effects. 

Pipeline
•MPN (Abnormal growth of blood cells)
- Polycythemia Vera (PV)  - EU (NDA), US (FDA meeting)
- Essential Thrombocythemia (ET) – applied Phase III in US, 2017 H2
- Chronic myeloid leukemia (CML) – IIT in US ongoing
- Myeloid Fibrosis (MF) - IIT in US ongoing
 
•Hepatitis (Combo with small molecule drugs)
- Chronic Hepatitis C (HCV) – Phase III in Taiwan and Korea
- Chronic Hepatitis B (HBV) – Phase II in Taiwan, Global Phase III in 2017 H2
 
•Cancer (Combine with PD1/PDL-1)
- HCC – will be in Phase I in 2018
Application
Ropeginterferon alfa 2b (P1101)
PharmaEssentia's novel pegylation technology platform has yielded our lead product, Ropeginterferon alfa-2b, which is a novel, long-acting, mono-pegylated proline interferon with improved pharmacokinetic properties allowing once every two weeks administration offering improved tolerability and convenience.


Ropeginterferon alfa-2b offers the following advantages:
  • Single-site PEGylation technology
  • Purest PEG-P-IFN P1101
  • Long-acting
  • Less frequent/ serious AE
  • Much higher MTD
  • Will apply for various indications
  • Flexible dosing adjustment

Ropeginterferon alfa-2b is designed to be the most purer interferon alpha designed; other interferon alphas on the market currently include PEG-Intron (Merck) and Pegasys (Roche).

Ropeginterferon alfa-2b has Orphan Drug designation in the United States of America and the European Union. We plan to commercialize Ropeginterferon alfa-2b in North and South America, as well as Asia. We have exclusively licensed the rights to Ropeginterferon alfa-2b to AOP Orphan for European, Commonwealth of Independent States (CIS), and Middle Eastern markets for the development and commercialization in the field of Myeloproliferative Neoplasms (MPNs).

 
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