Ropeginterferon alfa-2b LA is under clinical development by PharmaEssentia and currently in Phase II for Hepatitis B. According to GlobalData, Phase II drugs for Hepatitis B have a 36% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Ropeginterferon alfa-2b LA’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

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

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 Ropeginterferon alfa-2b, TCRT, P1101, Anti PD-1 (P1801), PEG-GCSF, PEG-cytokine X, Y, Novel checkpoint Abs. 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 hematology and oncology. The company operates in Taiwan, Japan, Hong Kong, Korea, Singapore and China. PharmaEssentia is headquartered in Taipei, Taiwan.

For a complete picture of Ropeginterferon alfa-2b LA’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 12 April 2024

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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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.