Patients & Healthcare Professionals News Career
Mobile Button Search>

Patients & Healthcare Professionals

At PharmaEssentia, we discover new treatments and deliver improvements to as many people as possible. We not only commit to patients exploring new ways to extend people’s lives, but also seeking collaboration and provide supports to healthcare professionals.

 

 
 

About Ropeginterferon alfa 2b (P1101)

PharmaEssentia's novel pegylation technology platform has yielded our lead product, Ropeginterferon alfa-2b, which is currently being explored in several indications. Ropeginterferon alfa-2b is a novel engineered interferon alpha 2b, designed to be the most purer interferon alpha designed. 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. Our 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, we creates novel products for better disease treatment. Compared with the similar drugs on the market, including PEG-Intron (Merck) and Pegasys (Roche), Ropeginterferon alfa-2b shows not only the most effective PK/PD data but also reduces severe side effects. 

Our Ropeginterferon alfa-2b offers the following advantages:

  • The predominantly single-site-specific conjugation pegylation, resulting in a >90% single isomer composition, it leads to a superior PK and safety to other Interferons and hydroxyurea (HU).
  • Much higher MTD than Pegasys and PEG-Intron, resulting in a dosing of one injection every 2 weeks (potentially every 4 weeks) vs. Pegasys and PEG-Introns’ once weekly injections.
  • Ropeginterferon alfa-2b is potentially offers disease modification and prevention of progression (SMF, other malignancies) and JAK2 burden reduction.  

 

Disease Education and Clinical Trial

Polycythemia vera (PV) is a rare, chronic disorder characterized by overproduction (proliferation) of red blood cells in the bone marrow. PV is typically associated with an elevated white blood cell count, an elevated platelet count, and an enlarged spleen (splenomegaly). The cause of PV is not completely understood, but it may be caused by genetic mutation. Nearly all PV patients have a mutation called “JAK2 V617F” (found in the JAk2 gene) in blood-forming cells. While Essential thrombocythemia (ET) is a chronic MPN previously called hemorrhagic thrombocythemia, is characterized by a sustained clonal proliferation of megakaryocytes in the bone marrow. The proliferation of megakaryocytes is primarily caused by clonal stem cells, as confirmed by enzyme and genetic analysis.

There is currently no cure for PV, currently available treatments includes phlebotomy, antiplatelet therapy, managing risk factors and cytoreductive therapies such as hydroxyurea (HU) and PEG-INF α-2a; meanwhile Hydroxyurea (HU) is generally considered the first-line therapy for ET. HU is very effective to the diseases, however many patients do not tolerate HU or suffer from anemia, leukopenia, skin lesions, or gastrointestinal symptoms, as the result interferon is another option for treatments.

Unfortunately the main problem with the current pegylated interferons (PegIntron and Pegasys) are patient tolerability, as these drugs induce severe flu-like symptoms and neuropsychiatric side effects. To solve the problems we develop Ropeginterferon alfa-2b which presents a much purer pegylated interferon (>90% 1 predominant isomer vs. PegIntron’s 14 isomers and Pegasys’ 8 isomers). As a result of our purer profile, we have seen data that indicates improved tolerability, compliance and thus long-term treatment outcomes. We are able to administer our product once every two weeks (vs. every week for other pegylated interferons) for enhanced tolerability. We explore Ropeginterferon alfa-2b in a variety of indications, not only for myeloproliferative neoplasms (MPNs) but also hepatitis B and hepatitis C.

► More about Rare Blood Disorders 

► More about Liver Infection 

► More about clinical trials 

► More about clinical trials for MPN diseases at MPN Foundation 

 

Patient Assistance 

For questions about medical inquiries, product information and services, we recommend you to contact our offices by regions.

  • Taiwan Tingfang Wang | tingfang_wang@pharmaessentia.com | Phone : +886-(2)-2655-7688
  • USA and Europe Craig Zimmerman | craig_zimmerman@pharmaessentia.com |Phone: +1-(617) 957-4736
  • Japan Katsuya Yonezu | Katsuya_Yonezu@pharmaessentia.com|Phone: +81-3-6866-9531
  • China Warren Chen | warrenshen@pharmaessentia.com | Phone: +86-10-8571-1234