Ropeginterferon alfa-2b LA is under clinical development by PharmaEssentia and currently in the Phase I, Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Ropeginterferon alfa-2b LA’s likelihood of approval (LoA) and phase transition for Hepatitis D took place on 21 Jul 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Ropeginterferon alfa-2b LA Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Ropeginterferon alfa-2b LA overview

Ropeginterferon alpha-2b (Besremi) is a long acting interferon. It is formulated as pegylated solution for subcutaneous route of administration. Besremi is indicated as monotherapy in adults for the treatment of polycythaemia vera without symptomatic splenomegaly.

Ropeginterferon alpha-2b (P-1101/AOP2014) is under development for the treatment of hepatitis B, adult T-cell leukemia, hepatitis C and hepatitis D infections, polycythemia vera, primary myelofibrosis, essential thrombocythemia, chronic myeloid leukaemia and corona virus caused by SARS(COVID-19). The drug candidate is administered as subcutaneous injection. It is a pegylated-IFN-alpha-2b formulation. It is a third-generation long-acting interferon. It is developed based on PEGylation technology, which is used to couple interferon alfa 2b with 40 kDa Peg via a proline molecule to form major positional isomer. It was also under development for solid tumor.

PharmaEssentia overview

PharmaEssentia is a biotechnology company. It operates as a developer of therapeutic products for the treatment of human diseases. The company’s pipeline product includes P1101, a new generation PEG-Interferon-alpha-2b which is developed using the PEGylation technology platform. Its pegylation technology platform is designed to increase the protein drug’s efficacy by prolonging its circulation in the bloodstream. PharmaEssentia’s products are used in the therapeutic areas of dermatology, hematology, infectious diseases and oncology. The company also develops oncology drugs for leukemia, gastric, esophageal, liver, and breast cancer. It collaborates with biotechnology companies, university research institutes, and pharmaceutical companies. The company operates in Taiwan, Japan, Hong Kong, Korea, Singapore and China. PharmaEssentia is headquartered in Taipei, Taiwan.

Quick View Ropeginterferon alfa-2b LA LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Ropeginterferon alfa-2b LA
Administration Pathway
  • Subcutaneous
Therapeutic Areas
  • Infectious Disease
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.