Zanubrutinib is under clinical development by BeiGene and currently in the Phase II, Phase III and Pre-Registration 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 Zanubrutinib’s likelihood of approval (LoA) and phase transition for Refractory Chronic Lymphocytic Leukemia (CLL) took place on 30 Apr 2021, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 30 Apr 2021 increased Zanubrutinib’s LoA and PTSR for Relapsed Chronic Lymphocytic Leukemia (CLL).

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

Zanubrutinib overview

Zanubrutinib (Brukinsa) acts as an antineoplastic agent. It is formulated as hard gelatin capsules for oral route of administration. Brukinsa is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, and the treatment of adult patients with chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL) who have received at least one prior therapy. Brukinsa is indicated for the treatment of adult patients with Waldenstrom’s macroglobulinemia (WM), Brukinsa is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least a previous therapy. Brukinsa is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.

Zanubrutinib (BGB-3111) is under development for the treatment of B-cell lymphoid malignancies such as relapsed/refractory diffuse large B-cell lymphoma, follicular lymphoma, relapsed/refractory mantle cell lymphoma, marginal zone lymphoma, Waldenstrom's macroglobulinemia, chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), Immune Thrombocytopenic Purpura and lupus nephritis. The drug candidate is administered through oral route and acts by targeting brutons tyrosine kinase (BTK). It was under development for the treatment of severe acute respiratory syndrome due to Coronavirus disease 2019 (COVID-19), pulmonary distress.

BeiGene overview

BeiGene is a biotechnology company. It is specialized in the development and commercialization of immuno-oncology medicines to treat cancers. The company offers BRUKINSA, a BTK (Bruton’s tyrosine kinase) inhibitor against mantle cell lymphoma (MCL). BeiGene is investigating Zanubrutinib (BGB-3111), a small molecule inhibitor of BTK to treat B cell malignancies; Tislelizumab (BGB-A317), a monoclonal antibody targeting solid tumors and hematologic cancer; and Pamiparib (BGB-290) against solid tumor malignancies. It seeks to work in partnership with academia, biotechnology and pharmaceutical companies to develop treatments for cancer patients. The company has operations in the US, Australia, Germany, Spain Switzerland, and Italy. BeiGene is headquartered in Beijing, China.

Quick View Zanubrutinib LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Zanubrutinib
Administration Pathway
  • Oral
Therapeutic Areas
  • Hematological Disorders
  • Immunology
  • 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.