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Details:
BeiGene has granted accelerated approval to Brukinsa (zanubrutinib), BTK Inhibitor for the treatment of adult patients with relapsed or refractory follicular lymphoma, in combination with the anti-CD20 monoclonal antibody obinutuzumab.
Lead Product(s): Zanubrutinib,Obinutuzumab
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 07, 2024
Details:
Brukinsa (zanubrutinib) is a small molecule inhibitor of BTK designed to deliver complete and sustained inhibition of the BTK protein. It is being evaluated for the treatment of relapsed/refractory chronic lymphocytic leukemia.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 29, 2024
Details:
Brukinsa (zanubrutinib) is a small molecule inhibitor of BTK. It is now approved by European Commision for the treatment of relapsed or refractory follicular lymphoma.
Lead Product(s): Zanubrutinib,Obinutuzumab
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2023
Details:
Brukinsa (zanubrutinib) is a small-molecule inhibitor of BTK that is receives positive recommendation from NICE in U.K. for adult patients with chronic lymphocytic leukemia.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 20, 2023
Details:
Brukinsa (zanubrutinib), a bruton’s tyrosine kinase inhibitor (BTKi), is being developed in combination with obinutuzumab for the treatment of adult patients with R/R follicular lymphoma (FL). If approved, brukinsa will be the first and only BTKi approved for FL.
Lead Product(s): Zanubrutinib,Obinutuzumab
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2023
Details:
Brukinsa (zanubrutinib) is a small-molecule inhibitor of BTK that is currently being developed in combination with obinutuzumab for the treament of adults with relapsed or refractory (R/R) follicular lymphoma and is approved for Mantle cell lymphoma.
Lead Product(s): Zanubrutinib,Obinutuzumab
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 12, 2023
Details:
The collaboration aims to provide access to Brukinsa (zanubrutinib), a kinase inhibitor, for the treatment of adult patients with chronic lymphocytic leukemia (CLL) in 29 low- and middle-income countries over the next three years.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: The Max Foundation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration May 17, 2023
Details:
Brukinsa (zanubrutinib) is a small-molecule inhibitor of BTK that is currently approved in China, for the treament of adults with chronic or small lymphocytic leukemia and Waldenström's macroglobulinemia.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 06, 2023
Details:
Under the agreement, BeiGene will provide zanubrutinib to Prelude and will collaborate for future evaluation of Prelude's investigational CDK9 inhibitor, PRT2527, in combination with it’s BTK inhibitor, zanubrutinib, in hematologic malignancies.
Lead Product(s): PRT2527,Zanubrutinib
Therapeutic Area: Oncology Product Name: PRT2527
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: BeiGene
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration March 15, 2023
Details:
Brukinsa (zanubrutinib) is a small-molecule inhibitor of Bruton’s tyrosine kinase (BTK) that is currently being evaluated for treating various B-cell malignancies. It has demonstrated to inhibit the proliferation of malignant B cells.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 19, 2023
Details:
Brukinsa (zanubrutinib) is a small-molecule inhibitor of Bruton’s tyrosine kinase (BTK) that is currently being evaluated for treating various B-cell malignancies. It has demonstrated to inhibit the proliferation of malignant B cells.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 19, 2023
Details:
BRUKINSA (zanubrutinib) is a small-molecule inhibitor of Bruton’s tyrosine kinase (BTK), specifically designed to deliver targeted and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 22, 2022
Details:
BRUKINSA (zanubrutinib) is a small-molecule inhibitor of BTK discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2022
Details:
BRUKINSA (zanubrutinib) is a small-molecule inhibitor of BTK discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2022
Details:
The CHMP recommendation is based on two global head-to-head Phase 3 clinical trials in which BRUKINSA demonstrated superior efficacy comparing BRUKINSA to ibrutinib in patients with R/R CLL and SEQUOIA (NCT03336333) comparing BRUKINSA to BR in patients with TN CLL.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2022
Details:
BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2022
Details:
BRUKINSA (zanubrutinib) is a small molecule inhibitor of BTK. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver targeted and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 19, 2022
Details:
In the Phase 2 study of BRUKINSA® (zanubrutinib), the ORR was 68% with 26% of patients achieving CR and 42% achieving PR. The median time to response was 2.8 months and ORRs for MZL subtypes extranodal, nodal, splenic, and unknown were 64%, 76%, 67%, and 50%, respectively.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 19, 2022
Details:
Submission included final response analysis from the global ALPINE clinical trial showing BRUKINSA (Zanubrutinib) demonstrated superiority versus ibrutinib in ORR as assessed by an Independent Review Committee in adult patients with CLL or SLL.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 13, 2022
Details:
BRUKINSA (zanubrutinib) is a next-generation BTK inhibitor designed as a highly potent, selective, bioavailable, and irreversible inhibitor with potentially advantageous pharmacokinetic and pharmacodynamic properties.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: NewBridge Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 13, 2022
Details:
In the ASPEN trial, BRUKINSA (zanubrutinib) demonstrated a more favorable safety profile compared to ibrutinib with lower frequency of certain adverse events, including atrial fibrillation or flutter (2% vs. 15%) and major hemorrhage (6% vs. 9%).
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 26, 2022
Details:
BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2022
Details:
BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Medison Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 15, 2022
Details:
BRUKINSA is a highly selective next-generation BTK inhibitor designed to improve tolerability by minimizing off-target binding. In clinical trials, BRUKINSA achieved a high overall response rate among relapsed/refractory MZL patients and was generally well-tolerated.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 03, 2022
Details:
The sNDA is supported by clinical results from the randomized, multicenter, global Phase 3 SEQUOIA trial, comparing BRUKINSA to bendamustine in combination with rituximab (B+R) in patients with treatment-naïve CLL.
Lead Product(s): Zanubrutinib,Bendamustine Hydrochloride,Rituximab
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 28, 2022
Details:
The recommended dose of BRUKINSA is either 160 mg twice daily or 320 mg once daily, taken orally with or without food. The dose may be adjusted for adverse reactions and reduced for patients with severe hepatic impairment and certain drug interactions.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 10, 2021
Details:
BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 17, 2021
Details:
BRUKINSA is small molecule inhibitor of Bruton’s tyrosine kinase received accelerated approval from U.S. Food and Drug Administration for treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least one anti-CD20-based regimen.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2021
Details:
The FDA’s approval of BRUKINSA in WM is primarily based on efficacy results from the multicenter, open-label Phase 3 ASPEN trial (NCT03053440) comparing BRUKINSA to ibrutinib in patients with WM.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 01, 2021
Details:
The Phase 3 ALPINE trial met the primary endpoint at interim analysis, with BRUKINSA showing superiority in investigator-assessed overall response rate versus ibrutinib.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2021
Details:
Compared to ibrutinib, BRUKINSA demonstrated superiority in investigator-assessed overall response rate in patients with relapsed or refractory CLL. Additionally, the event rate of atrial fibrillation or flutter was also significantly lower with BRUKINSA.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2021
Details:
Combination of PI3K-Delta Inhibitor Zandelisib (ME-401) and BTK Inhibitor Zanubrutinib in Patients with Relapsed or Refractory (R R) B-cell Malignancies data presented at the European Hematology Association 2021.
Lead Product(s): Zandelisib,Zanubrutinib
Therapeutic Area: Oncology Product Name: ME-401
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Kyowa Kirin
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2021
Details:
BRUKINSA met the primary endpoint of the trial, demonstrating non-inferiority in objective response rate (ORR) by both investigator and independent review committee (IRC) assessments. also showed superior ORR for BRUKINSA vs. ibrutinib.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2021
Details:
BRUKINSA (zanubrutinib) is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK), discovered by BeiGene scientists.
Lead Product(s): Zanubrutinib
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Brukinsa
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 08, 2021
Details:
The approval in Canada for BRUKINSA was based on efficacy results from the Phase 3 ASPEN clinical trial that evaluated BRUKINSA compared to ibrutinib in patients with relapsed/refractory (R/R) or treatment-naïve (TN) WM who harbor a MYD88 mutation (MYD88MUT).
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 08, 2021
Details:
Multiple clinical presentations on company's BTK inhibitor BRUKINSA® (zanubrutinib) and non-clinical data on its anti-PD-1 antibody tislelizumab will be presented in an oral presentation and four posters at the 62nd ASH Annual Meeting.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 05, 2020
Details:
The Health Canada has accepted for review and granted priority review status to BeiGene's marketing application seeking approval of BTK inhibitor Brukinsa (zanubrutinib) for the treatment of Waldenström’s macroglobulinemia (WM).
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 09, 2020
Details:
BeiGene's Brukinsa (zanubrutinib) has been accepted for review by regulators in Europe to treat patients with Waldenström’s macroglobulinemia (WM).
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Brukinsa
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 18, 2020
Details:
BTK inhibitor BRUKINSA™ (zanubrutinib) has received approval from the China NMPA in 2 indications: chronic lymphocytic leukemia/small lymphocytic lymphoma who have received at least one prior therapy, and mantle cell lymphoma who have received at least one prior therapy.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2020
Details:
Medison will commercialize BeiGene’s BTK inhibitor BRUKINSA™ (zanubrutinib) in Israel and the acceptance of a new drug application (NDA) in Israel for BRUKINSA for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
Lead Product(s): Zanubrutinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: BeiGene
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 21, 2020
Details:
BeiGene has submitted a phase-2 randomized trial to the Food and Drug Administration that plans to enroll 42 U.S. patients.
Lead Product(s): Zanubrutinib
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 16, 2020
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