Zanubrutinib is a Small Molecule owned by BeiGene, and is involved in 70 clinical trials, of which 23 were completed, 35 are ongoing, and 12 are planned.

Zanubrutinib is a small-molecule inhibitor of BTK. Zanubrutinib forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK activity. BTK is a signaling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. In B-cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion. In nonclinical studies, zanubrutinib inhibited malignant B-cell proliferation and reduced tumor growth.

Zanubrutinib (BGB-3111) is a BTK inhibitor. Bruton’s tyrosine kinase (BTK) is expressed mainly in malignant cell and is involved in multiple signal-transduction pathways regulating survival, activation, proliferation, and differentiation of B-lineage lymphoid cells. It is an upstream activator of multiple anti apoptotic signaling molecules and networks, including the signal transducer and activator of transcription 5 (STAT5) protein, phosphatidylinositol (PI) 3-kinase/AKT/mammalian target of rapamycin (mTOR) pathway, and nuclear factor kappa B. Inhibition of BTK blocks the resultant cascade of events and might alleviate the condition and treat cancer.

The revenue for Zanubrutinib is expected to reach a total of $38.7bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Zanubrutinib NPV Report.

Zanubrutinib was originated by BeiGene (Beijing) and is currently owned by BeiGene.

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.

The company reported revenues of (US Dollars) US$1,176.3 million for the fiscal year ended December 2021 (FY2021), compared to a revenue of US$308.9 million in FY2020. The operating loss of the company was US$1,438.7 million in FY2021, compared to an operating loss of US$1,657.7 million in FY2020. The net loss of the company was US$1,413.4 million in FY2021, compared to a net loss of US$1,596.9 million in FY2020. The company reported revenues of US$387.6 million for the third quarter ended September 2022, a decrease of 40.2% over the previous quarter.

Quick View – Zanubrutinib

Report Segments
  • Innovator (NME)
Drug Name
  • Zanubrutinib
Administration Pathway
  • Oral
Therapeutic Areas
  • Hematological Disorders
  • Immunology
  • Infectious Disease
  • Oncology
Key Companies
Highest Development Stage
  • Marketed

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

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.