Orelabrutinib is under clinical development by InnoCare Pharma and currently in Phase II for Relapsed Chronic Lymphocytic Leukemia (CLL). According to GlobalData, Phase II drugs for Relapsed Chronic Lymphocytic Leukemia (CLL) have a 29% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Orelabrutinib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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.

Orelabrutinib overview

Orelabrutinib (Inokai) acts as an anti-cancer agent. It is formulated as tablets for oral route of administration. It is indicated for the treatment of relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma and relapsed/refractory mantle cell lymphoma and Neuromyelitis optica spectrum disorder (NMOSD).
ICP-022 is under development for the treatment of chronic primary immune thrombocytopenia, systemic lupus erythematosus, relapsed/ refractory primary and secondary central nervous system lymphoma, refractory and relapsed marginal zone lymphoma, relapsed/refractory Waldenstrom macroglobulinemia, relapsed and refractory mantle cell lymphoma, chronic lymphocytic leukemia and small lymphocytic lymphoma,relapsed and refractory diffuse large B-cell lymphoma and relapsed, refractory follicular lymphoma and relapsing-remitting multiple sclerosis and relapsed, refractory non-Hodgkin' lymphoma and extranodal marginal zone B-Cell lymphoma (Mucosa-Associated Lymphoid Tissue or MALT-Lymphoma) and nodal marginal zone B-Cell lymphoma. It is administered by the oral route as an uncoated tablet. It acts by targeting BTK. It was also under development for rheumatoid arthritis and pemphigus.

Orelabrutinib is under development for the treatment of primary immune thrombocytopenia (ITP).

InnoCare Pharma overview

InnoCare Pharma (InnoCare) is a biopharmaceutical company that discovers and develops novel treatments for cancer and autoimmune diseases. The company’s pipeline product portfolio includes ICP-022 a Bruton Tyrosine Kinase (BTK) inhibitor to treat B cell malignancies; ICP-105, an inhibitor for the treatment of hepatocellular carcinoma (HCC); ICP-192 a novel compound that targets gene abnormalities in solid tumor. It serves in the therapeutic areas of gastrointestinal cancer, liver cancer, lupus and rheumatoid arthritis. The company builds a fully integrated biopharmaceutical platform with strong in-house research and development capabilities, including drug target identification and verification, preclinical evaluation, clinical trial design and execution, drug manufacturing and quality control. It operates in the US and China. InnoCare is headquartered in Changping, Beijing, China.

For a complete picture of Orelabrutinib’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 15 September 2023

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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.