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Pegberon - Peginterferon alfa-2b injection, Y-shape

 

 

 

 

Pegberon® is the first 40kD PEG modified interferon alfa-2b medicine in the world, and it is indicated for chronic hepatitis C (CHC) and chronic hepatitis B (CHB). Comparing with other peginterferon alfa products modified by 12kD linear PEG or 40kD U-shape branched PEG in the market, Pegberon® has following advanced features:


      Exclusive international patent Y-shape branched PEG structure improves the drug stability;


      Pegylation by 40kD PEG strengthens the stability of serum drug concentration;


      Selective pegylation at high activity site results in higher antiviral activity;


      Lower incidence of neutralizing antibody brings higher possibility to achieve SVR.


To well assess its efficacy and safety, the clinical trials (phase I, II, III) of Pegberon® comparing with the launched peginteferon alfa-2a in CHC and CHB treatment have been finished in China.


      More than 2,000 patients are involved (CHC: >1,000 patients; CHB: >1,000 patients);


      The first macromolecular medicine which completed the head-to-head clinical comparative trials from phase I to phase III in China;


      The first genotyping clinical study for CHC treatment (phase III, N=770) in China;


      Till now the largest patient size (phase III, N=820) of registry clinical studies of peginterferon for CHB treatment in the world.


Besides, various quality studies and preclinical studies (pharmacodynamics, safety pharmacology, pharmacokinetics and toxicology) have been also finished in China.



 

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Last modified: 11/08/16