Drugs / Zanubrutinib
Regulatory milestones approvals, filings & regulatory actions · 25 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed B-cell chronic lymphocytic leukemia 1 milestone | |||||
| Filed | Other | — | B-cell chronic lymphocytic leukemia | 2022-08-04 | “Received acceptance by Health Canada for supplemental new drug submission (sNDS) for zanubrutinib in chronic lymphocytic leukemia (CLL)” beonemedicines.com ↗ |
| Filed chronic lymphocytic leukemia/small lymphocytic lymphoma 1 milestone | |||||
| Filed | China (NMPA) | BRUKINSA | chronic lymphocytic leukemia/small lymphocytic lymphoma | 2020-05-21 | “NDAs in China for relapsed refractory (R/R) MCL and R/R chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) have been accepted” beonemedicines.com ↗ |
| Filed follicular lymphoma, susceptibility to 5 milestones | |||||
| Filed | EU (EMA) | BRUKINSA | follicular lymphoma, susceptibility to | — | “EMA acceptance of our filing for BRUKINSA in combination with obinutuzumab as a treatment for patients with relapsed or refractory follicular lymphoma” beonemedicines.com ↗ “The European Medicines Agency recently validated BeiGene’s Type II variation application for BRUKINSA for the treatment of adult patients with R/R FL.” beonemedicines.com ↗ |
| Filed | UK (MHRA) | BRUKINSA | follicular lymphoma, susceptibility to | — | “BeiGene’s submission for BRUKINSA in R/R FL is under review by regulatory authorities in Canada, Switzerland, and the United Kingdom” beonemedicines.com ↗ |
| Filed | Other | BRUKINSA | follicular lymphoma, susceptibility to | — | “BeiGene’s submission for BRUKINSA in R/R FL is under review by regulatory authorities in Canada, Switzerland, and the United Kingdom” beonemedicines.com ↗ |
| Filed | US (FDA) | BRUKINSA | follicular lymphoma, susceptibility to | — | “BeiGene currently has submissions for BRUKINSA in R/R FL under review by regulatory authorities including in the United States (U.S.) and China.” beonemedicines.com ↗ |
| Filed | China (NMPA) | BRUKINSA | follicular lymphoma, susceptibility to | — | “BeiGene currently has submissions for BRUKINSA in R/R FL under review by regulatory authorities including in the United States (U.S.) and China.” beonemedicines.com ↗ “BeiGene currently has submissions for BRUKINSA in R/R FL under review by regulatory authorities in the European Union and China.” beonemedicines.com ↗ |
| Filed mantle cell lymphoma 4 milestones | |||||
| Filed | Other | BRUKINSA | mantle cell lymphoma | 2020-05-21 | “Filed and received acceptance of two NDAs by the Australia Therapeutic Goods Administration (TGA) for BRUKINSA in relapsed/refractory (R/R) MCL and WM” beonemedicines.com ↗ “acceptance of a new drug application (NDA) in Israel for BRUKINSA for the treatment of patients with mantle cell lymphoma (MCL)” beonemedicines.com ↗ |
| Filed | China (NMPA) | BRUKINSA | mantle cell lymphoma | 2020-05-21 | “NDAs in China for relapsed refractory (R/R) MCL and R/R chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) have been accepted” beonemedicines.com ↗ |
| Filed | US (FDA) | — | mantle cell lymphoma | 2019-08-21 | “FDA has accepted the company’s New Drug Application (NDA) for zanubrutinib for the treatment of patients with mantle cell lymphoma (MCL)” beonemedicines.com ↗ |
| Filed | China (NMPA) | — | mantle cell lymphoma | 2018-08-26 | “In August, the NMPA accepted BeiGene’s first NDA for zanubrutinib for the treatment of patients with R/R mantle cell lymphoma (MCL).” beonemedicines.com ↗ “acceptance by the China Drug Administration (CDA) of a new drug application (NDA) for zanubrutinib” beonemedicines.com ↗ |
| Filed marginal zone lymphoma 2 milestones | |||||
| Filed | Japan (PMDA) | — | marginal zone lymphoma | 2026-05-06 | “Submitted New Drug Application in Japan for R/R MZL and tablet formulation.” beonemedicines.com ↗ |
| Filed | US (FDA) | BRUKINSA | marginal zone lymphoma | 2021-05-19 | “FDA has accepted a supplemental new drug application (sNDA) for BRUKINSA® (zanubrutinib) for the treatment of adult patients with marginal zone lymphoma” beonemedicines.com ↗ |
| Filed Waldenstrom macroglobulinemia 6 milestones | |||||
| Filed | Other | BRUKINSA | Waldenstrom macroglobulinemia | 2021-11-04 | “acceptance of the marketing authorization application (MAA) from Swissmedic” beonemedicines.com ↗ |
| Filed | Other | BRUKINSA | Waldenstrom macroglobulinemia | 2021-08-18 | “Swissmedic has accepted the marketing authorization application (MAA) for BRUKINSA, a treatment option for adult patients with Waldenström’s macroglobulinaemia (WM).” beonemedicines.com ↗ |
| Filed | US (FDA) | BRUKINSA | Waldenstrom macroglobulinemia | 2021-02-17 | “FDA has accepted a supplemental new drug application (sNDA) for BRUKINSA® (zanubrutinib) for the treatment of adult patients with Waldenström’s Macroglobulinemia (WM).” beonemedicines.com ↗ |
| Filed | Other | BRUKINSA | Waldenstrom macroglobulinemia | 2020-09-09 | “its New Drug Submission (NDS) for BRUKINSA® (zanubrutinib) for the treatment of patients with Waldenström’s macroglobulinemia (WM) has been accepted by Health Canada” beonemedicines.com ↗ “Filed and received acceptance of two NDAs by the Australia Therapeutic Goods Administration (TGA) for BRUKINSA in relapsed/refractory (R/R) MCL and WM” beonemedicines.com ↗ |
| Filed | EU (EMA) | BRUKINSA | Waldenstrom macroglobulinemia | 2020-06-18 | “The European Medicines Agency is currently reviewing a Type II variation marketing authorization application (MAA) for the new tablet formulation of BRUKINSA” beonemedicines.com ↗ “Announced the acceptance of a marketing authorization application (MAA) by the European Medicines Agency (EMA) for BRUKINSA” beonemedicines.com ↗ |
| Filed | China (NMPA) | BRUKINSA | Waldenstrom macroglobulinemia | — | “a supplemental new drug application (sNDA) of BRUKINSA in patients with relapsed/refractory Waldenström’s macroglobulinemia (WM) has been accepted by the Center for Drug...” beonemedicines.com ↗ “Received acceptance from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for a supplemental new drug application (sNDA) of BRUKINSA” beonemedicines.com ↗ “An sNDA of BRUKINSA in patients with relapsed/refractory WM has been accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration” beonemedicines.com ↗ “An sNDA of BRUKINSA in patients with relapsed/refractory WM has been accepted by the CDE of the NMPA” beonemedicines.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (4) | US (FDA) | BRUKINSA | — | 2021-08-31 – 2024-03-07 | fda.gov ↗ |
| Approved | EU (EMA) | Brukinsa | — | 2021-11-22 | europa.eu ↗ |
| Approved | US (FDA) | BRUKINSA | — | 2019-11-14 | fda.gov ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 126 trials · 1 met primary | ||||||
| Phase 1 | NCT06675123 | Jun 2026 → Mar 2028 expected | mantle cell lymphoma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 1 | NCT07548255 | Apr 2026 → Mar 2029 expected | mantle cell lymphoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07315373 | Dec 2025 → Dec 2028 expected | autoimmune thrombocytopenia | Peking University People's Hospital | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07141511 | Sep 2025 → Feb 2026 | — | BeOne Medicines | Completed | No outcome recorded |
| Phase 1 | NCT06824701 | Sep 2025 → Jan 2032 expected | B-cell non-Hodgkin lymphoma | University of Utah | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06859008 | Aug 2025 → Jan 2029 expected | MALT lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, diffuse large B-cell lymphoma, mantle cell lymphoma +2 | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06735664 | Aug 2025 → Dec 2027 expected | Richter transformation | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 1 | NCT06730542 | Apr 2025 → Apr 2030 expected | central nervous system cancer | Juan P. Alderuccio, MD | Recruiting | No outcome recorded |
| Phase 1 | NCT06547944 | Jan 2024 → Dec 2025 overdue | chronic lymphocytic leukemia/small lymphocytic lymphoma | Institute of Hematology & Blood Diseases Hospital, China | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05665530 | Sep 2023 → Jun 2025 | Richter transformation, T-cell non-Hodgkin lymphoma, acute myeloid leukemia, chronic lymphocytic leukemia/small lymphocytic lymphoma +5 | Prelude Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT05547399 | Jun → Dec 2022 | — | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT04850495 | Nov 2021 → Jun 2026 overdue | diffuse large B-cell lymphoma | Yazeed Sawalha | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04551963 | Nov 2020 → Feb 2022 | B-cell neoplasm | BeiGene | Completed | Mixed |
| Phase 1 | NCT04436107 | Sep 2020 → Mar 2024 | diffuse large B-cell lymphoma | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT04470908 | Jul → Nov 2020 | — | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT04277637 | Mar 2020 → May 2027 expected | neoplasm of mature B-cells | BeOne Medicines | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03666000 | Mar 2019 → Jun 2027 expected | B-cell acute lymphoblastic leukemia, chronic lymphocytic leukemia/small lymphocytic lymphoma | Imugene Limited | Recruiting | No outcome recorded |
| Phase 1 | NCT03561298 | Jun 2018 | — | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT03465059 | May → Oct 2018 | — | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT03432884 | Jan → Apr 2018 | — | BeiGene | Completed | Met primary |
| Phase 1 | NCT03301181 | Sep → Nov 2017 | — | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT04163783 | Mar → Apr 2017 | — | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT03189524 | Jul 2016 → Aug 2020 | B-cell neoplasm | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT02795182 | Jun 2016 → Dec 2020 | leukemia, lymphoma | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT04163523 | May → Jul 2016 | — | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT02569476 | Jan 2016 → Sep 2020 | B-cell neoplasm | BeiGene | Completed | No outcome recorded |
| Phase 1/26 trials | ||||||
| Phase 1/2 | NCT06634589 | Nov 2024 → Dec 2028 expected | B-cell non-Hodgkin lymphoma | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06029309 | May 2024 → May 2028 expected | mantle cell lymphoma | Alvaro Alencar, MD | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06375733 | Mar 2024 → Dec 2026 expected | large B-cell lymphoma | Genfleet Therapeutics (Shanghai) Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04282018 | Apr 2020 → Aug 2024 | chronic lymphocytic leukemia/small lymphocytic lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma +1 | BeiGene | Completed | No outcome recorded |
| Phase 1/2 | NCT04172246 | Jan 2020 → May 2023 | neoplasm of mature B-cells | BeiGene | Completed | No outcome recorded |
| Phase 1/2 | NCT02343120 | Sep 2014 → Mar 2021 | B-cell neoplasm | BeiGene | Completed | No outcome recorded |
| Phase 2138 trials · 6 met primary · 2 missed | ||||||
| Phase 2 | NCT07812246 | Aug 2027 → Aug 2028 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | City of Hope Medical Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07674810 | Dec 2026 → Apr 2027 expected | B-cell chronic lymphocytic leukemia | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07739459 | Dec 2026 → Apr 2029 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | The Lymphoma Academic Research Organisation | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07638722 | Oct 2026 → Apr 2034 expected | MALT lymphoma, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma | SWOG Cancer Research Network | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07734038 | Oct 2026 → Dec 2027 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Kerry Rogers | Recruiting | No outcome recorded |
| Phase 2 | NCT07839247 | Sep 2026 → Oct 2027 expected | primary central nervous system lymphoma | Xiaohui Ren | Recruiting | No outcome recorded |
| Phase 2 | NCT07550855 | Sep 2026 → Mar 2028 expected | follicular lymphoma | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07799220 | Sep 2026 → Sep 2028 expected | mantle cell lymphoma | Memorial Sloan Kettering Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07341191 | Aug 2026 → Dec 2029 expected | mantle cell lymphoma | Canadian Cancer Trials Group | Recruiting | No outcome recorded |
| Phase 2 | NCT07682415 | Jun 2026 → Dec 2029 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Yi Shuhua | Not yet recruiting | No outcome recorded |
| Show all 138 trials opens the full record — a long page | ||||||
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05707377 | Apr 2023 → Oct 2027 expected | idiopathic membranous glomerulonephritis | BeOne Medicines | Active not recruiting | No outcome recorded |
| Phase 314 trials · 3 met primary | ||||||
| Phase 3 | NCT07321652 | Apr 2026 → Sep 2028 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Alliance for Clinical Trials in Oncology | Recruiting | No outcome recorded |
| Phase 3 | NCT07277231 | Jan 2026 → Feb 2031 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 3 | NCT05735834 | May 2024 → May 2029 expected | splenic marginal zone lymphoma | International Extranodal Lymphoma Study Group (IELSG) | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06073821 | Nov 2023 → Feb 2032 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | BeOne Medicines | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05976763 | Oct 2023 → Aug 2038 expected | mantle cell lymphoma | Alliance for Clinical Trials in Oncology | Recruiting | No outcome recorded |
| Phase 3 | NCT05100862 | Mar 2022 → Jul 2028 expected | marginal zone lymphoma | BeOne Medicines | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05179733 | Mar 2022 → Dec 2025 | diffuse large B-cell lymphoma | Ruijin Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT05320575 | Feb 2022 → Aug 2023 | hemophagocytic syndrome | Beijing Friendship Hospital | Completed | No outcome recorded |
| Phase 3 | NCT05020392 | Sep 2021 → Oct 2023 | B-cell chronic lymphocytic leukemia, Burkitt lymphoma, diffuse large B-cell lymphoma, follicular lymphoma +1 | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Unknown | No outcome recorded |
| Phase 3 | NCT05164770 | Mar 2021 → Dec 2023 | high grade B-cell lymphoma, high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement, mantle cell lymphoma | Shandong Provincial Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT04170283 | Jan 2020 → Nov 2027 expected | B-cell neoplasm | BeiGene | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04002297 | Aug 2019 → Apr 2026 overdue | mantle cell lymphoma | BeOne Medicines | Active not recruiting | Met primary |
| Phase 3 | NCT03734016 | Nov 2018 → Aug 2022 | chronic lymphocytic leukemia/small lymphocytic lymphoma | BeiGene | Completed | Met primary |
| Phase 3 | NCT03336333 | Oct 2017 → May 2021 overdue | chronic lymphocytic leukemia/small lymphocytic lymphoma | BeiGene | Active not recruiting | Met primary |
| Phase 43 trials | ||||||
| Phase 4 | NCT07474961 | Mar 2027 → Dec 2036 expected | Waldenstrom macroglobulinemia, plasma cell myeloma | Anne Louise Tølbøll Sørensen | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07270835 | Nov 2025 → Apr 2027 expected | neoplasm of mature B-cells, secondary hemophagocytic lymphohistiocytosis | The First Affiliated Hospital of Soochow University | Recruiting | No outcome recorded |
| Phase 4 | NCT07169331 | Oct 2025 → Oct 2028 expected | Waldenstrom macroglobulinemia | BeiGene | Recruiting | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT07299331 | Jan 2026 → Apr 2031 expected | marginal zone lymphoma | Zhengzhou University | Not yet recruiting | No outcome recorded |
| — | NCT07126678 | Jul 2025 → Jul 2028 expected | follicular lymphoma | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| — | NCT06942507 | May 2025 → Apr 2027 expected | Waldenstrom macroglobulinemia | Peking Union Medical College Hospital | Not yet recruiting | No outcome recorded |
| — | NCT06445257 | Sep 2023 → Apr 2026 | primary central nervous system lymphoma | Huai'an First People's Hospital | Unknown | No outcome recorded |
| — | NCT05797948 | Jul 2022 → Jun 2024 | B-cell non-Hodgkin lymphoma | The First Affiliated Hospital of Soochow University | Unknown | No outcome recorded |
| — | NCT05117814 | Sep 2021 → Jan 2023 | central nervous system non-hodgkin lymphoma | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04052854 | — | Waldenstrom macroglobulinemia | BeiGene | No longer available | No outcome recorded |
| Comparator or background therapy14 trials | ||||||
| Phase 1 | NCT02914938 Background | Oct 2016 → Mar 2023 | chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular lymphoma, high grade B-cell lymphoma, mantle cell lymphoma +1 | MEI Pharma, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT07052695 Background | Nov 2025 → Dec 2028 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | Inhye Ahn | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06697184 Background | Jan 2025 → Nov 2029 expected | B-cell chronic lymphocytic leukemia, mantle cell lymphoma | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 2 | NCT07271667 Background | Apr 2026 → Nov 2027 expected | B-cell chronic lymphocytic leukemia | Curis, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT07350850 Comparator | Dec 2025 → Dec 2028 expected | primary central nervous system lymphoma | Tongji Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06958705 Background | Dec 2025 → Dec 2027 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT06520098 Background | Oct 2025 → Jun 2030 expected | chronic lymphocytic leukemia/small lymphocytic lymphoma | VA Office of Research and Development | Recruiting | No outcome recorded |
| Phase 2 | NCT06524375 Background | Aug 2024 → Oct 2026 expected | B-cell chronic lymphocytic leukemia | Genentech, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04840602 Comparator | Jan 2022 → Mar 2028 expected | Waldenstrom macroglobulinemia | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 3 | NCT07377578 Comparator | Feb 2026 → May 2031 expected | mantle cell lymphoma | Guangzhou Lupeng Pharmaceutical Company LTD. | Recruiting | No outcome recorded |
| Phase 3 | NCT06742996 Background | Mar 2025 → Aug 2028 expected | mantle cell lymphoma | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 3 | NCT06522555 Background | Jul 2024 → Aug 2028 expected | diffuse large B-cell lymphoma | Ruijin Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT04662255 Comparator | Apr 2021 → Nov 2027 expected | mantle cell lymphoma | Loxo Oncology, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03053440 Comparator | Jan 2017 → Jun 2022 | Waldenstrom macroglobulinemia | BeiGene | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 125
| Date | Issuer | Release |
|---|---|---|
| 2026-06-30 | BeOne Medicines | Results BeOne Medicines Announces Positive Phase 3 Results for BRUKINSA in Frontline Mantle Cell Lymphoma beonemedicines.com ↗
Foundational BTKi BRUKINSA plus rituximab reduced the risk of progression or death by 43% versus bendamustine plus rituximab (HR=0.57; p<0.0001), meeting the primary endpoint of PFS |
| 2026-06-12 | BeOne Medicines | Results BeOne Medicines’ Foundational Hematology Franchise Leads Next Era of B-Cell Cancer Innovation at EHA 2026 beonemedicines.com ↗
These data are complemented by results from the all-oral combination of BRUKINSA® (zanubrutinib) plus next-generation BCL2 inhibitor BEQALZI™ (sonrotoclax; ZS), which continue to demonstrate rapid, deep, durable responses across multiple B-cell malignancies. |
| 2026-06-11 | BeOne Medicines | Results BeOne Showcases Landmark Phase 3 Data in CLL Patients Aged 80+ at EHA 2026, Reinforcing BRUKINSA Benefit beonemedicines.com ↗
The subgroup analysis will be presented alongside the 78-month SEQUOIA dataset, the longest reported follow-up for a next-generation BTK inhibitor in first-line CLL, showing a 78-month PFS of 71.8% for BRUKINSA versus 31.0% for bendamustine-rituximab. |
| 2026-05-29 | BeOne Medicines | Results BeOne Medicines Establishes Standard for Long-Term Disease Control in CLL with BRUKINSA 78-Month Data at ASCO 2026 beonemedicines.com ↗
After a median follow-up of 84.01 months (range, 0.0-101.5), BRUKINSA continued to show benefit over bendamustine-rituximab (BR) in patients with treatment-naive CLL/SLL, with progression-free survival (PFS) outcomes that are unprecedented among BTK inhibitors. |
| 2026-05-21 | BeOne Medicines | Results BeOne Medicines Sets the Pace in Oncology at ASCO and EHA 2026 with 60+ Abstracts beonemedicines.com ↗
A subgroup analysis of SEQUOIA, which includes one of the largest and longest-followed cohorts of patients aged ≥80 years ever reported in a Phase 3 CLL study, showing that age did not limit benefit. |
| 2025-12-07 | BeOne Medicines | Results Sonrotoclax Data at ASH 2025 Confirm Foundational Potential Across B-cell Malignancies beonemedicines.com ↗
In 135 efficacy-evaluable patients, ORR was 100%, with CR/CR with incomplete count recovery (CRi) in 55% of the 320-mg cohort. |
| 2025-11-20 | BeOne Medicines | Results BeOne Medicines Showcases Leadership in B-cell Malignancies at ASH 2025 beonemedicines.com ↗
SEQUOIA: BRUKINSA demonstrated sustained overall survival (84%; 88% after COVID adjustment) and landmark progression-free survival (PFS) superiority vs bendamustine + rituximab with an estimated 74% PFS at 6 years in treatment-naïve chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) (Poster Presentation: 2129) |
| 2025-08-21 | BeOne Medicines | Regulatory European Commission Approves Tablet Formulation of BeOne Medicines’ BRUKINSA® for All Approved Indications beonemedicines.com ↗
BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Commission has approved a new film-coated tablet formulation of BRUKINSA® (zanubrutinib) for all approved indications. |
| 2025-06-26 | BeOne Medicines | Results BeOne Medicines Showcases Groundbreaking Oncology Pipeline at R&D Day beonemedicines.com ↗
Meanwhile, early data show the combination of sonrotoclax and BRUKINSA has demonstrated compelling efficacy and the potential to offer a best-in-class fixed-duration treatment in CLL, setting the stage for a possible new standard of care. |
| 2025-06-25 | BeOne Medicines | Regulatory BeOne Medicines Receives Positive CHMP Opinion for Tablet Formulation of BRUKINSA® beonemedicines.com ↗
BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending approval of a new film-coated tablet formulation of BRUKINSA® (zanubrutinib) for all approved indications. |
| 2025-06-11 | BeOne Medicines | Regulatory U.S. FDA Approves Tablet Formulation of BeOne’s BRUKINSA® for All Approved Indications beonemedicines.com ↗
BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved a new tablet formulation of BRUKINSA® (zanubrutinib) for all five approved indications. |
| 2025-06-09 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals to Launch DCGI-approved BRUKINSA® in India to Advance Treatment of Hematological Malignancies glenmarkpharma.com ↗
Glenmark Pharmaceuticals Ltd. (Glenmark) a research-led, global pharmaceutical company, has announced the upcoming launch of zanubrutinib in India following approval by the Drugs Controller General of India (DCGI). |
| 2025-05-31 | BeOne Medicines | Results BeOne Medicines Presents New SEQUOIA Study Results Reinforcing BRUKINSA’s Differentiated Profile with or without Venetoclax in Frontline CLL at ASCO 2025 beonemedicines.com ↗
Data from the Arm D of SEQUOIA demonstrate that treatment with BRUKINSA plus venetoclax has the potential to drive progression-free survival and overall deep and durable responses across the frontline CLL patient spectrum, including patients with high-risk mutational status. |
| 2025-05-22 | BeOne Medicines | Results BeiGene Presents Pioneering Cancer Research at ASCO 2025 – Redefining Treatment Across Hematology and Solid Tumors beonemedicines.com ↗
New data from SEQUOIA, to be reported in two oral presentations, underscore the benefits of BRUKINSA® as first-line treatment for patients with chronic lymphocytic leukemia (CLL) |
| 2025-02-20 | Sellas Life Sciences Group | Results SELLAS Announces Positive Data from Phase 2a Trial of SLS009 in Combination with Zanubrutinib in DLBCL sellaslifesciences.com ↗
The results showed an overall response rate of 67%, more than double the expected overall response rate (ORR) of zanubrutinib alone. |
| 2024-12-11 | Prelude Therapeutics | Results Prelude Therapeutics Presents Preliminary Results of Phase 1 Dose-escalation Study of PRT2527 as Monotherapy and in Combination with Zanubrutinib in Patients with Relapsed/Refractory Lymphoid Malignancies preludetx.com ↗
PRT2527 monotherapy and in combination with zanubrutinib demonstrated an acceptable safety profile with evidence of preliminary activity in patients with relapsed/refractory lymphoid malignancies, including patients who received prior CAR-T therapy. |
| 2024-12-09 | BeOne Medicines | Results BeiGene Advances Leadership in CLL at ASH 2024 with New Data From Its Hematology Franchise Including BRUKINSA® and Novel Pipeline Assets beonemedicines.com ↗ |
| 2024-11-05 | BeOne Medicines | Results BeiGene Highlights Innovative Hematology Portfolio Across B-cell Malignancies at ASH 2024 beonemedicines.com ↗
Five-year follow-up results from Cohort 1 of the Phase 3 SEQUOIA study showed sustained progression-free survival (PFS) benefit with BRUKINSA in patients with treatment-naïve chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), with no new safety signals observed. |
| 2024-10-16 | BeOne Medicines | Results BeiGene Highlights Waldenström’s Macroglobulinemia Innovation at IWWM 2024 beonemedicines.com ↗
The study also finds that efficacy is also maintained or improved in these patients. |
| 2024-06-14 | BeOne Medicines | Results BeiGene to Present New Data from SEQUOIA Study Evaluating BRUKINSA® plus Venetoclax in High-Risk First-Line CLL/SLL at EHA2024 beonemedicines.com ↗ |
| 2024-05-24 | BeOne Medicines | Results BRUKINSA® Data at ASCO Underscore Differentiated Clinical Profile for Treatment of CLL and SLL beonemedicines.com ↗
The analysis found a statistically significant improvement in PFS for BRUKINSA over acalabrutinib in high-risk patients and a trend toward improvement in overall survival (OS), overall response (ORR) and complete response (CR). |
| 2024-05-14 | BeOne Medicines | Results BeiGene Highlights New Hematology Portfolio and Pipeline Data at EHA2024 beonemedicines.com ↗
Oral presentation sharing the results of an adverse event (AE) based economic analysis comparing BRUKINSA with acalabrutinib; in terms of AE management, BRUKINSA was cost-saving and associated with quality of life benefits compared to acalabrutinib (Abstract S333) |
| 2024-03-07 | BeOne Medicines | Regulatory BeiGene Announces FDA Accelerated Approval of BRUKINSA for the Treatment of Relapsed or Refractory Follicular Lymphoma beonemedicines.com ↗
The indication is approved under accelerated approval based on response rate and durability of response, marking BRUKINSA’s fifth indication in B-cell malignancies in the U.S. |
| 2024-02-29 | BeOne Medicines | Results BeiGene Announces New Efficacy Analysis Comparing BRUKINSA® vs Acalabrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia beonemedicines.com ↗
The analysis suggests a progression-free survival and complete response advantage for BRUKINSA versus acalabrutinib, as well as potentially improved overall survival. |
| 2023-12-22 | BeOne Medicines | Regulatory FDA Approves Label Update for BRUKINSA® (zanubrutinib) in Chronic Lymphocytic Leukemia (CLL) beonemedicines.com ↗ |
| 2023-11-28 | BeOne Medicines | Results BeiGene to Present New Data Highlighting Hematology Portfolio and Pipeline Strengths at ASH 2023 beonemedicines.com ↗
BRUKINSA® (zanubrutinib) continues to show progression free survival (PFS) benefit compared with ibrutinib in extended follow-up of patients with relapsed/refractory (R/R) chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL) in the ALPINE trial |
| 2023-11-17 | BeOne Medicines | Regulatory BeiGene Receives European Commission Approval for BRUKINSA® (zanubrutinib) for the Treatment of Relapsed or Refractory Follicular Lymphoma beonemedicines.com ↗ |
| 2023-10-20 | BeOne Medicines | Regulatory BRUKINSA® Receives Positive Recommendation from NICE in U.K. for Adult Patients with Chronic Lymphocytic Leukemia beonemedicines.com ↗
The committee considered that zanubrutinib is a cost-effective use of NHS resources in CLL. |
| 2023-10-13 | BeOne Medicines | Regulatory BeiGene Receives Positive CHMP Opinion for BRUKINSA® (zanubrutinib) in Relapsed or Refractory Follicular Lymphoma beonemedicines.com ↗
CHMP recommends approval for BRUKINSA plus obinutuzumab as a treatment for adult patients who have received at least two prior lines of therapy |
| 2023-07-12 | BeOne Medicines | Regulatory BeiGene Announces FDA Acceptance of sNDA for Fifth BRUKINSA® Indication beonemedicines.com ↗ |
| 2023-06-15 | BeOne Medicines | Results BeiGene Highlights Significant BRUKINSA® (zanubrutinib) Data at the 17th International Conference on Malignant Lymphoma beonemedicines.com ↗
In a subgroup analysis of the Phase 3 ALPINE trial (NCT03734016), BRUKINSA showed improved PFS over ibrutinib in patients in China with R/R chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), consistent with the global study population. |
| 2023-06-09 | BeOne Medicines | Results BeiGene Highlights Promising Data from Blood Cancer Portfolio and Pipeline at the European Hematology Association Hybrid Congress beonemedicines.com ↗
BRUKINSA continued to demonstrate clinically meaningful efficacy in patients with treatment-naïve CLL/SLL without del(17p). |
| 2023-05-30 | BeOne Medicines | Regulatory BRUKINSA® Approved in Canada for the Treatment of Chronic Lymphocytic Leukemia beonemedicines.com ↗
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, announced today that BRUKINSA (zanubrutinib), a Bruton's tyrosine kinase inhibitor (BTKi), has been approved by Health Canada for the treatment of adult patients with chronic lymphocytic leukemia (CLL). |
| 2023-05-25 | BeOne Medicines | Results BeiGene Presentations at the 2023 ASCO Annual Meeting Reinforce Promise Across Oncology Portfolio beonemedicines.com ↗
In an updated analysis of the ROSEWOOD study, BRUKINSA in combination with obinutuzumab demonstrated clinically meaningful activity and manageable safety profile in patients with heavily pretreated relapsed/refractory (R/R) follicular lymphoma (FL). |
| 2023-05-06 | BeOne Medicines | Regulatory BeiGene Receives New Approvals for BRUKINSA® (zanubrutinib) in China beonemedicines.com ↗
BRUKINSA is approved for first-line treatment for CLL/SLL and WM in China and has multiple approved indications in more than 65 markets worldwide |
| 2023-01-19 | BeOne Medicines | Regulatory BRUKINSA® Approved in the U.S. for Chronic Lymphocytic Leukemia beonemedicines.com ↗
BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has approved its Bruton’s tyrosine kinase inhibitor (BTKi) BRUKINSA (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). |
| 2023-01-19 | BeOne Medicines | Regulatory BRUKINSA® (zanubrutinib) Receives Marketing Authorization for Chronic Lymphocytic Leukemia (CLL) and Marginal Zone Lymphoma (MZL) in Great Britain by MHRA beonemedicines.com ↗ |
| 2022-12-13 | BeOne Medicines | Results BeiGene’s BRUKINSA® (zanubrutinib) Demonstrated Superior Progression-Free Survival Over IMBRUVICA® (ibrutinib) in Chronic Lymphocytic Leukemia in Late-Breaker at ASH beonemedicines.com ↗
In this final analysis, BRUKINSA achieved superior PFS over ibrutinib (HR: 0.65 [95% CI, 0.49-0.86] p=0.0024, for both Independent Review Committee [IRC] and investigator). |
| 2022-11-22 | BeOne Medicines | Results BeiGene to Present Final PFS Results from ALPINE Trial Demonstrating Superior PFS for BRUKINSA® Versus IMBRUVICA® in Late-Breaking Oral Session at ASH 2022 beonemedicines.com ↗
In this final PFS analysis, BRUKINSA achieved superior PFS compared with ibrutinib, as assessed by both Independent Review Committee (IRC) and investigator (HR: 0.65 [95% CI, 0.49-0.86] p =.0024, for both investigator and IRC). |
| 2022-11-17 | BeOne Medicines | Regulatory BeiGene Receives European Commission Approval for BRUKINSA® (zanubrutinib) for the Treatment of Adults with Chronic Lymphocytic Leukemia (CLL) beonemedicines.com ↗
BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the European Commission (EC) has approved BRUKINSA® (zanubrutinib) for the treatment of adult patients with treatment-naïve (TN) or relapsed/refractory (R/R) CLL. |
| 2022-11-10 | BeOne Medicines | Regulatory BeiGene Announces Brazil Approvals for BRUKINSA® As a Treatment for Rare Blood Cancers beonemedicines.com ↗
BRUKINSA (zanubrutinib) has been approved in Brazil for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) and adult patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. |
| 2022-11-02 | BeOne Medicines | Regulatory BeiGene Receives European Commission Approval for BRUKINSA® (zanubrutinib) for the Treatment of Adults with Marginal Zone Lymphoma beonemedicines.com ↗
BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the European Commission (EC) has granted marketing authorization of BRUKINSA® (zanubrutinib) for the treatment of adult patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy. |
| 2022-10-26 | BeOne Medicines | Regulatory BeiGene Expands Reach of its Innovative BTK Inhibitor with Recent Regulatory Approvals in Latin America beonemedicines.com ↗
BRUKINSA® received Marketing Authorization as a treatment for rare blood cancers in six countries in Central and South America |
| 2022-10-14 | BeOne Medicines | Regulatory BeiGene Receives Positive CHMP Opinion for BRUKINSA® (zanubrutinib) for the Treatment of Adults With CLL beonemedicines.com ↗
today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of BRUKINSA® (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL). |
| 2022-10-12 | BeOne Medicines | Results BeiGene Announces Positive Topline Results from Final Progression-Free Survival Analysis of BRUKINSA® (zanubrutinib) Compared to IMBRUVICA® (ibrutinib) in Phase 3 Chronic Lymphocytic Leukemia (CLL) Trial beonemedicines.com ↗
today announced that BRUKINSA® (zanubrutinib) achieved superior Progression-Free Survival (PFS) versus IMBRUVICA® (ibrutinib) in a final analysis of the Phase 3 ALPINE trial, as assessed by an independent review committee (IRC) and investigator. |
| 2022-09-19 | BeOne Medicines | Regulatory NICE Recommends BeiGene’s BRUKINSA® (zanubrutinib) for Patients with Waldenström’s Macroglobulinemia who have had at Least One Treatment beonemedicines.com ↗
This decision from NICE marks BRUKINSA as the first and only treatment for WM to be recommended for routine use in England and Wales. |
| 2022-09-19 | BeOne Medicines | Regulatory BeiGene Receives Positive CHMP Opinion for BRUKINSA® (zanubrutinib) for the Treatment of Adults with Marginal Zone Lymphoma beonemedicines.com ↗ |
| 2022-06-13 | BeOne Medicines | Regulatory BeiGene Announces PDUFA Goal Date Extension for U.S. sNDA for BRUKINSA for the Treatment of CLL/SLL beonemedicines.com ↗
The FDA extended the PDUFA goal date to allow time to review additional clinical data submitted by BeiGene, which was deemed a major amendment to the sNDA. |
| 2022-06-13 | BeOne Medicines | Regulatory BeiGene Announces BRUKINSA™ (zanubrutinib) Is Approved in 50 Markets beonemedicines.com ↗ |
| 2022-06-10 | BeOne Medicines | Results BeiGene Highlights Growing Portfolio and Pipeline Targeting Hematologic Malignancies at European Hematology Association 2022 Congress beonemedicines.com ↗
The ROSEWOOD trial met its primary endpoint, with a 68.3% ORR in the zanubrutinib plus obinutuzumab arm versus 45.8% in the obinutuzumab arm (p = 0.0017) and median follow-up of 12.5 months. |
| 2022-05-26 | BeOne Medicines | Results BeiGene Clinical Data Presentations at 2022 ASCO Annual Meeting Demonstrate Mature and Growing Oncology Portfolio beonemedicines.com ↗ |
| 2022-04-28 | BeOne Medicines | Regulatory BeiGene Announces BRUKINSA (zanubrutinib) Approval in Uruguay in Mantle Cell Lymphoma, Marginal Zone Lymphoma, and Waldenström’s Macroglobulinemia beonemedicines.com ↗
BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, today announced that the BTK inhibitor BRUKINSA (zanubrutinib) has been approved in Uruguay for the treatment of adult patients with previously treated mantle cell lymphoma (MCL), relapsed or refractory marginal zone lymphoma (MZL), and Waldenström’s macroglobulinemia (WM). |
| 2022-04-11 | BeOne Medicines | Results IRC Determines BRUKINSA® (Zanubrutinib) Demonstrates Superior Overall Response Rate Versus Ibrutinib in Final Response Analysis of ALPINE Trial in Chronic Lymphocytic Leukemia beonemedicines.com ↗ |
| 2022-03-15 | BeOne Medicines | Regulatory BeiGene and Medison Announce Approval and National Reimbursement in Israel for BRUKINSA® (zanubrutinib) for the Treatment of Waldenström's Macroglobulinemia beonemedicines.com ↗
BeiGene (NASDAQ: BGNE; HKEX: 06160, SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, and Medison Pharma Ltd. a global pharma company focused on providing access to highly innovative therapies to patients in international markets ("Medison"), today announced that the State of Israel Ministry of Health has approved BRUKINSA® (zanubrutinib) for the treatment of adult patients with Waldenström’s Macroglobulinemia (WM). |
| 2022-03-03 | BeOne Medicines | Regulatory BeiGene Announces Health Canada Approval for BRUKINSA® (zanubrutinib) in Relapsed or Refractory Marginal Zone Lymphoma beonemedicines.com ↗
BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines, today announced that BRUKINSA® (zanubrutinib) has been approved by Health Canada for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy. |
| 2022-02-22 | BeOne Medicines | Regulatory BeiGene Announces U.S. FDA Acceptance of Supplemental New Drug Application for BRUKINSA (zanubrutinib) in Chronic Lymphocytic Leukemia beonemedicines.com ↗
BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) for BRUKINSA® (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). |
| 2022-02-22 | BeOne Medicines | Regulatory BeiGene Announces European Medicines Agency Acceptance of Applications for BRUKINSA (zanubrutinib) in Chronic Lymphocytic Leukemia and Marginal Zone Lymphoma beonemedicines.com ↗
BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, today announced that the European Medicines Agency (EMA) has accepted for review two new indication applications for its BTK inhibitor BRUKINSA® (zanubrutinib) for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of patients with marginal zone lymphoma (MZL). |
| 2022-02-17 | BeOne Medicines | Regulatory BeiGene Announces Approval for BRUKINSA (zanubrutinib) by Swissmedic for Treatment of Adult Patients with Waldenström’s Macroglobulinemia beonemedicines.com ↗ |
| 2022-01-28 | BeOne Medicines | Regulatory BeiGene Announces Acceptance of Supplemental New Drug Application in China for BRUKINSA (zanubrutinib) in Chronic Lymphocytic Leukemia with Breakthrough Therapy Designation beonemedicines.com ↗
BRUKINSA was granted its first breakthrough therapy designation in China with this application |
| 2022-01-20 | BeOne Medicines | Regulatory BeiGene Announces Acceptance of a Supplemental New Drug Application in China for BRUKINSA (zanubrutinib) in Waldenström’s Macroglobulinemia beonemedicines.com ↗
The sNDA acceptance is welcoming news, and following BRUKINSA’s recent NMPA approval for patients with WM in the relapsed or refractory setting, this represents an opportunity to expand access to more WM patients in China, subject to NMPA approval. |
| 2021-12-15 | BeOne Medicines | Regulatory BeiGene Announces Authorisation of BRUKINSA (zanubrutinib) from the United Kingdom’s MHRA for the Treatment of Adults with Waldenström’s Macroglobulinemia in Great Britain beonemedicines.com ↗
Today’s authorisation of BRUKINSA will soon allow eligible patients in Great Britain to access an important new treatment option that may offer improved outcomes. |
| 2021-12-12 | BeOne Medicines | Results BeiGene Presents Results from SEQUOIA Trial of BRUKINSA (zanubrutinib) in First-Line Chronic Lymphocytic Leukemia at the 63rd ASH Annual Meeting beonemedicines.com ↗
BRUKINSA demonstrated superiority in progression-free survival over chemoimmunotherapy as a first-line treatment for patients with chronic lymphocytic leukemia |
| 2021-12-11 | BeOne Medicines | Results BeiGene Presents Updated Safety and Efficacy Findings on BRUKINSA (zanubrutinib) in BTK Inhibitor-Intolerant Patients with Relapsed or Refractory B-Cell Malignancies beonemedicines.com ↗
BeiGene (NASDAQ: BGNE; HKEX: 06160), a global, science-driven biotechnology company focused on developing innovative and affordable medicines, today presented additional safety and efficacy results from an ongoing Phase 2 trial evaluating BRUKINSA® (zanubrutinib) in patients with previously treated B-cell malignancies who were intolerant to ibrutinib and/or acalabrutinib. |
| 2021-12-02 | BeOne Medicines | Regulatory BeiGene Announces Inclusion in the China National Reimbursement Drug List (NRDL) of Tislelizumab in Three New Indications, BRUKINSA® (Zanubrutinib) in One New Indication, and the First Listing for Pamiparib beonemedicines.com ↗
BeiGene-discovered medicines in the updated NRDL include: anti-PD-1 antibody tislelizumab in three new indications, including in lung and liver cancers; BTK inhibitor BRUKINSA® (zanubrutinib) in one new indication; and the initial listing for PARP inhibitor pamiparib. |
| 2021-12-02 | BeOne Medicines | Regulatory BeiGene Announces Inclusion in the China National Reimbursement Drug List (NRDL) of Tislelizumab in Three New Indications, BRUKINSA® (Zanubrutinib) in One New Indication, and the First Listing for Pamiparib beonemedicines.com ↗
BeiGene-discovered medicines in the updated NRDL include: anti-PD-1 antibody tislelizumab in three new indications, including in lung and liver cancers; BTK inhibitor BRUKINSA® (zanubrutinib) in one new indication; and the initial listing for PARP inhibitor pamiparib. |
| 2021-11-23 | BeOne Medicines | Regulatory BeiGene Announces Approval of BRUKINSA (zanubrutinib) in the European Union for Treatment of Adults with Waldenström’s Macroglobulinemia beonemedicines.com ↗ |
| 2021-11-14 | BeOne Medicines | Regulatory BeiGene and NewBridge Pharmaceuticals Announce Approval in Saudi Arabia of BRUKINSA® (Zanubrutinib) for the Treatment of Patients with Relapsed or Refractory Mantle Cell Lymphoma beonemedicines.com ↗ |
| 2021-11-04 | BeOne Medicines | Results BeiGene to Present Clinical Data on BRUKINSA in Chronic Lymphocytic Leukemia at the 63rd ASH Annual Meeting beonemedicines.com ↗
Data from the randomized Cohort 1 of SEQUOIA met the primary endpoint at interim analysis, with BRUKINSA achieving a highly statistically significant improvement in progression-free survival (PFS) compared to B+R regimen. |
| 2021-10-20 | BeOne Medicines | Regulatory BeiGene and Nanolek Announce Approval in Russia for BRUKINSA® (Zanubrutinib) for Treatment of Patients with Relapsed or Refractory Mantle Cell Lymphoma beonemedicines.com ↗
today announced that BRUKINSA® (zanubrutinib) has received approval from the Russia Ministry of Health for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. |
| 2021-10-10 | BeOne Medicines | Regulatory BeiGene Announces BRUKINSA® (Zanubrutinib) Approved for Treatment of Patients with Mantle Cell Lymphoma beonemedicines.com ↗ |
| 2021-10-07 | BeOne Medicines | Regulatory BeiGene Announces First Regulatory Approval in Australia for BRUKINSA® (Zanubrutinib) for Treatment of Patients with Waldenström’s Macroglobulinemia beonemedicines.com ↗
today announced that BRUKINSA® (zanubrutinib) has been approved in Australia for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or in first line treatment for patients unsuitable for chemo-immunotherapy. |
| 2021-09-17 | BeOne Medicines | Regulatory BeiGene Receives Positive CHMP Opinion for BRUKINSA® (Zanubrutinib) for the Treatment of Adults with Waldenström’s Macroglobulinemia beonemedicines.com ↗
today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending approval of BRUKINSA (zanubrutinib) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or first-line treatment for patients unsuitable for chemo-immunotherapy. |
| 2021-09-15 | BeOne Medicines | Regulatory U.S. FDA Grants BRUKINSA® (Zanubrutinib) Accelerated Approval in Relapsed or Refractory Marginal Zone Lymphoma beonemedicines.com ↗
This marks the third FDA approval for BRUKINSA and first approval in marginal zone lymphoma |
| 2021-09-01 | BeOne Medicines | Regulatory U.S. FDA Grants BRUKINSA® (Zanubrutinib) Approval in Waldenström’s Macroglobulinemia beonemedicines.com ↗
This marks the second FDA approval for BRUKINSA and its third approval in Waldenström’s macroglobulinemia globally |
| 2021-08-18 | BeOne Medicines | Regulatory BeiGene Announces Acceptance by Swissmedic of Marketing Authorization Application for BRUKINSA® (Zanubrutinib) in Waldenström’s Macroglobulinaemia beonemedicines.com ↗
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, announced that Swissmedic has accepted the marketing authorization application (MAA) for BRUKINSA, a treatment option for adult patients with Waldenström’s macroglobulinaemia (WM). |
| 2021-07-29 | BeOne Medicines | Results BeiGene Announces Positive Topline Results from Phase 3 SEQUOIA Trial Comparing BRUKINSA® (Zanubrutinib) to Bendamustine Plus Rituximab in Patients with Treatment-Naïve Chronic Lymphocytic Leukemia beonemedicines.com ↗
With a median follow-up of 25.8 months, the SEQUOIA trial met the primary endpoint of progression-free survival (PFS) as assessed by independent review committee (IRC), as BRUKINSA achieved a highly statistically significant improvement in PFS compared to B+R. |
| 2021-07-26 | BeOne Medicines | Regulatory BeiGene Announces Approval in Canada of BRUKINSA® (Zanubrutinib) for the Treatment of Patients with Mantle Cell Lymphoma beonemedicines.com ↗
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, today announced that BRUKINSA® (zanubrutinib) has been approved by Health Canada for the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy. |
| 2021-06-18 | BeOne Medicines | Regulatory BeiGene Announces China NMPA Approval of BRUKINSA® (Zanubrutinib) for the Treatment of Patients with Relapsed or Refractory Waldenström’s Macroglobulinemia beonemedicines.com ↗
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that BRUKINSA® (zanubrutinib) has received conditional approval from the China National Medical Products Administration (NMPA) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy. |
| 2021-06-11 | BeOne Medicines | Results BeiGene Presents Long-Term Efficacy and Safety Results from Three Pivotal Trials of BRUKINSA® (Zanubrutinib) and Tislelizumab at EHA2021 beonemedicines.com ↗
BRUKINSA demonstrated long-term clinical benefits and tolerability in patients with mantle cell lymphoma and chronic lymphocytic leukemia at extended follow-up of nearly three years |
| 2021-06-11 | BeOne Medicines | Results BeiGene Presents ALPINE Results at EHA2021 Demonstrating Both Efficacy and Safety Advantages of BRUKINSA® (Zanubrutinib) in Head-to-Head Comparison to Ibrutinib in Chronic Lymphocytic Leukemia beonemedicines.com ↗
The Phase 3 ALPINE trial met the primary endpoint at interim analysis, with BRUKINSA showing superiority in investigator-assessed overall response rate versus ibrutinib |
| 2021-06-01 | BeOne Medicines | Results BeiGene Announces First Presentation of the Phase 3 ALPINE Trial Comparing BRUKINSA® (Zanubrutinib) to Ibrutinib in Chronic Lymphocytic Leukemia to Be Featured in Presidential Symposium at EHA2021 beonemedicines.com ↗
BRUKINSA demonstrated superior objective response rate by investigator assessment in the planned interim analysis |
| 2021-05-20 | Kyowa Kirin, Inc. | Results MEI Pharma and Kyowa Kirin Announce New Clinical Data on Zandelisib at American Society of Clinical Oncology Annual Meeting 2021 –Zandelisib, an investigational agent, +/- rituximab demonstrated 82% overall response rate in patients with relapsed or refractory (r/r) follicular lymphoma (FL) who had progression of disease within 24 months of first line chemoimmunotherapy (POD24); overall response rate of 93% in non-POD24– –An 8% discontinuation rate was observed in the combined study population– –Zandelisib and zanubrutinib combination therapy demonstrated 100% response rate in patients with r/r indolent B-cell malignancies; combination administered on an optimized dosing regimen with no additive toxicity to each agent alone– –Trial design for Phase 3 COASTAL study, intended to act as the required confirmatory study for the potential U.S. accelerated approval of zandelisib, will also be featured in a poster– kyowakirin.com ↗ |
| 2021-05-19 | BeOne Medicines | Regulatory BeiGene Announces U.S. FDA Acceptance and Priority Review of Supplemental New Drug Application for BRUKINSA® (Zanubrutinib) in Marginal Zone Lymphoma beonemedicines.com ↗
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) for BRUKINSA® (zanubrutinib) for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy and granted priority review. |
| 2021-05-12 | BeOne Medicines | Results BeiGene Highlights Progress in Hematology at EHA2021 Virtual Congress beonemedicines.com ↗
From results in the accepted abstracts, BRUKINSA demonstrated deep and durable responses across all subgroups in these trials, including high-risk patients, with a median follow-up over 33 months. |
| 2021-04-28 | BeOne Medicines | Results BRUKINSA® (Zanubrutinib) Demonstrates Superior Objective Response Rate by Investigator Assessment and Reduced Rates of Atrial Fibrillation or Flutter at Interim Analysis in Head-to-Head Trial Against Ibrutinib in Chronic Lymphocytic Leukemia beonemedicines.com ↗
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 (p < 0.0001). |
| 2021-04-08 | BeOne Medicines | Results BeiGene Provides Update on Phase 2 Clinical Trial of Zanubrutinib in Patients with COVID-19-Related Pulmonary Distress beonemedicines.com ↗
Trial did not meet the co-primary efficacy endpoints; no new safety signals identified |
| 2021-03-02 | BeOne Medicines | Regulatory Health Canada Approves BRUKINSA® (Zanubrutinib) for the Treatment of Waldenström’s Macroglobulinemia beonemedicines.com ↗
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that BRUKINSA® (zanubrutinib) has been approved by Health Canada for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). |
| 2021-02-17 | BeOne Medicines | Regulatory BeiGene Announces U.S. FDA Acceptance of Supplemental New Drug Application for BRUKINSA (Zanubrutinib) in Waldenström’s Macroglobulinemia beonemedicines.com ↗
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) for BRUKINSA® (zanubrutinib) for the treatment of adult patients with Waldenström’s Macroglobulinemia (WM). |
| 2020-12-27 | BeOne Medicines | Regulatory BeiGene Announces Inclusion of Three Innovative Oncology Products in China National Reimbursement Drug List (NRDL) beonemedicines.com ↗
The NRDL’s inclusion of tislelizumab, BRUKINSA, and XGEVA will help expand access to these high-quality oncology treatments across China and alleviate the financial burden for many cancer patients and their families. |
| 2020-12-07 | BeOne Medicines | Results BeiGene Presents Clinical Data on BRUKINSA® (Zanubrutinib) in B-Cell Malignancies and Waldenström’s Macroglobulinemia at the 62nd ASH Annual Meeting beonemedicines.com ↗
In previously treated patients with B-cell malignancies who were intolerant to other BTK inhibitors, adverse events were unlikely to recur on zanubrutinib with responses maintained or improved compared to prior treatment |
| 2020-12-06 | BeOne Medicines | Results BeiGene Announces Data on BRUKINSA® (Zanubrutinib) from Phase 2 Trial in Marginal Zone Lymphoma and Phase 3 Trial in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma at the 62nd ASH Annual Meeting beonemedicines.com ↗
Zanubrutinib was shown to be highly active in patients with relapsed/refractory marginal zone lymphoma in initial results from the Phase 2 MAGNOLIA trial |
| 2020-09-09 | BeOne Medicines | Regulatory BeiGene Announces Acceptance and Priority Review by Health Canada of New Drug Submission for BRUKINSA® (zanubrutinib) in Waldenström’s Macroglobulinemia beonemedicines.com ↗
its New Drug Submission (NDS) for BRUKINSA® (zanubrutinib) for the treatment of patients with Waldenström’s macroglobulinemia (WM) has been accepted by Health Canada and granted priority review status. |
| 2020-06-18 | BeOne Medicines | Regulatory BeiGene Announces European Medicines Agency Acceptance of its Marketing Authorization Application for BRUKINSA® (Zanubrutinib) for the Treatment of Patients with Waldenström’s Macroglobulinemia beonemedicines.com ↗ |
| 2020-06-12 | BeOne Medicines | Results BeiGene Presents Clinical Data on Zanubrutinib and Tislelizumab at the 25th European Hematology Association (EHA) Virtual Congress beonemedicines.com ↗ |
| 2020-06-03 | BeOne Medicines | Regulatory BeiGene Announces the Approval of BRUKINSA™ (Zanubrutinib) in China for Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma and Relapsed/Refractory Mantle Cell Lymphoma beonemedicines.com ↗
BRUKINSA™ (zanubrutinib) has received approval from the China National Medical Products Administration (NMPA) in two indications |
| 2020-05-29 | BeOne Medicines | Results BeiGene Presents Updated Head to Head Results from Phase 3 Trial of Zanubrutinib vs. Ibrutinib in Patients with Waldenström’s Macroglobulinemia at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program beonemedicines.com ↗ |
| 2020-05-21 | BeOne Medicines | Regulatory BeiGene and Medison Pharma Announce Exclusive Distribution Agreement and Acceptance of New Drug Application for BTK Inhibitor BRUKINSA™ (zanubrutinib) in Israel beonemedicines.com ↗
Our first distribution agreement for BRUKINSA and the acceptance of our first NDA outside of the United States and China marks a significant step in realizing our global commercialization plans. |
| 2019-12-16 | BeOne Medicines | Results BeiGene Announces Results of Phase 3 ASPEN Trial of Zanubrutinib Compared to Ibrutinib for the Treatment of Patients with Waldenström’s Macroglobulinemia beonemedicines.com ↗
today announced results from the Phase 3 ASPEN trial comparing its BTK inhibitor BRUKINSA™ (zanubrutinib) to ibrutinib for the treatment of Waldenström’s macroglobulinemia (WM). |
| 2019-12-08 | BeOne Medicines | Results BeiGene Announces Clinical Data on BRUKINSA™ (Zanubrutinib) at the 61st American Society of Hematology (ASH) Annual Meeting beonemedicines.com ↗ |
| 2019-11-14 | BeOne Medicines | Regulatory U.S. FDA Grants BeiGene’s BRUKINSA™ (zanubrutinib) Accelerated Approval to Treat Adult Patients with Mantle Cell Lymphoma Who Received at Least One Prior Therapy beonemedicines.com ↗
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that BRUKINSA™ (zanubrutinib) has received accelerated approval from the United States Food and Drug Administration (FDA) as a treatment for mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy. |
| 2019-08-21 | BeOne Medicines | Regulatory BeiGene Announces U.S. FDA Acceptance and Grant of Priority Review for its New Drug Application of Zanubrutinib in Patients with Relapsed/Refractory Mantle Cell Lymphoma beonemedicines.com ↗
The FDA granted Priority Review for the NDA and has set a Prescription Drug User Fee Act (PDUFA) target action date of February 27, 2020. |
| 2019-06-20 | BeOne Medicines | Results BeiGene Presents Pivotal Phase 2 Clinical Results of Zanubrutinib in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma at the 15th International Conference on Malignant Lymphoma (ICML) beonemedicines.com ↗
The results of this trial in patients with relapsed/refractory CLL or SLL are part of our NDA in China, where patients with this disease have far fewer treatment options than in the West. |
| 2019-06-20 | BeOne Medicines | Results BeiGene Announces Phase 1b Clinical Results of Zanubrutinib in Combination with GAZYVA® (Obinutuzumab) in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Follicular Lymphoma at the 15th International Conference on Malignant Lympho beonemedicines.com ↗
These data demonstrated that zanubrutinib, in combination with the anti-CD20 monoclonal antibody obinutuzumab was generally well-tolerated, with the majority of adverse events being grade 1 or 2. |
| 2019-06-19 | BeOne Medicines | Results BeiGene Announces Updated Results from Two Ongoing Clinical Trials of Zanubrutinib in Patients with Mantle Cell Lymphoma in Presentations at the 15th International Conference on Malignant Lymphoma (ICML) beonemedicines.com ↗ |
| 2019-06-14 | BeOne Medicines | Results BeiGene Announces Clinical Results from Three Posters on Zanubrutinib Presented at the 24th Congress of European Hematology Association (EHA) beonemedicines.com ↗
The poster presentation included clinical results from a nonrandomized exploratory cohort of patients with the MYD88WT genotype of WM. |
| 2019-01-14 | BeOne Medicines | Regulatory BeiGene Receives U.S. FDA Breakthrough Therapy Designation for Zanubrutinib in Mantle Cell Lymphoma beonemedicines.com ↗
We are very excited to receive the Breakthrough Therapy designation from the FDA, |
| 2018-12-01 | BeOne Medicines | Results BeiGene Announces Clinical Results of Zanubrutinib in Mantle Cell Lymphoma From Two Presentations at the 60th American Society of Hematology Annual Meeting beonemedicines.com ↗ |
| 2018-11-15 | BeOne Medicines | Regulatory Priority Review Granted to BeiGene’s New Drug Applications for Zanubrutinib and Tislelizumab in China beonemedicines.com ↗
“We’re excited that the NDAs for both zanubrutinib and tislelizumab are receiving priority review by the NMPA,” |
| 2018-10-24 | BeOne Medicines | Regulatory BeiGene Announces Acceptance of its New Drug Application in China and Top-Line Pivotal Data for Zanubrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma beonemedicines.com ↗ |
| 2018-10-12 | BeOne Medicines | Results BeiGene Announces Updated Results from Phase 1 Clinical Trial of Zanubrutinib in Patients with Waldenström’s Macroglobulinemia beonemedicines.com ↗
With more than 70 patients with WM now treated, we continue to see a high rate of deep and durable responses across genotypes, including high rates of overall, major, and very good partial responses (VGPRs), |
| 2018-09-21 | BeOne Medicines | Results BeiGene Announces Preliminary Results from the Phase 1 Clinical Trial of Zanubrutinib in Chinese Patients with B-Cell Lymphoma at Annual Meeting of the Chinese Society of Clinical Oncology beonemedicines.com ↗ |
| 2018-08-26 | BeOne Medicines | Regulatory BeiGene Announces Acceptance of its First New Drug Application for Zanubrutinib in Relapsed/Refractory Mantle Cell Lymphoma by China Drug Administration beonemedicines.com ↗
today announced the acceptance by the China Drug Administration (CDA) of a new drug application (NDA) for zanubrutinib, an investigational Bruton's tyrosine kinase (BTK) inhibitor, for the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL). |
| 2018-07-22 | BeOne Medicines | Regulatory BeiGene Announces Plan to Pursue Accelerated Approval in the U.S. of BTK Inhibitor Zanubrutinib in Waldenström Macroglobulinemia (WM) beonemedicines.com ↗
today announced that its investigational BTK inhibitor zanubrutinib has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with Waldenström macroglobulinemia (WM). |
| 2018-06-15 | BeOne Medicines | Results BeiGene Provides Development Update and Presents Clinical Data on Zanubrutinib at the 23rd Congress of the European Hematology Association beonemedicines.com ↗
BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today presented results on its investigational BTK inhibitor zanubrutinib, from two poster presentations at the 23rd Congress of the European Hematology Association (EHA). |
| 2017-12-11 | BeOne Medicines | Results BeiGene Presents Initial Phase 1b Data for BTK Inhibitor Zanubrutinib (BGB-3111) Combined with PD-1 Antibody Tislelizumab (BGB-A317) at the 59th American Society of Hematology Annual Meeting beonemedicines.com ↗
The initial dose escalation data suggest that the combination of zanubrutinib and tislelizumab had a manageable toxicity profile and anti-tumor activity in patients with B-cell malignancies. |
| 2017-12-09 | BeOne Medicines | Results BeiGene Presents Updated Preliminary Phase 1b Data on BTK Inhibitor Zanubrutinib (BGB-3111) Combined with GAZYVA® (Obinutuzumab) at the 59th American Society of Hematology Annual Meeting beonemedicines.com ↗
The updated preliminary Phase 1b data demonstrated that the combination was generally well tolerated and was highly active in patients with FL and treatment-naïve (TN) or relapsed or refractory (R/R) CLL/SLL. |
| 2017-12-09 | BeOne Medicines | Results BeiGene Presents Preliminary Phase 1b Data on BTK Inhibitor Zanubrutinib (BGB-3111) in Non-Hodgkin’s Lymphoma at the 59th American Society of Hematology Annual Meeting beonemedicines.com ↗
The Phase 1b data suggest that zanubrutinib was generally well-tolerated and had anti-tumor activity across these NHL subtypes. |
| 2017-06-16 | BeOne Medicines | Results BeiGene Presents Initial Phase 1 Data on BTK Inhibitor BGB-3111 Combined with Obinutuzumab at the 14th International Conference on Malignant Lymphoma and Announces Additional Planned Global Registrational Trials for BGB-3111 beonemedicines.com ↗
The preliminary clinical results to date suggest that the combination is well tolerated and highly active in patients with CLL or SLL and FL. |
| 2017-06-15 | BeOne Medicines | Results BeiGene Presents Updated Phase 1 Data on BTK Inhibitor BGB-3111 in Patients with Waldenström’s Macroglobulinemia at the 14th International Conference on Malignant Lymphoma beonemedicines.com ↗
The updated data continue to suggest that BGB-3111 is well tolerated in WM. |
| 2017-06-14 | BeOne Medicines | Results BeiGene Presents Updated Phase 1 Data on BTK Inhibitor BGB-3111 in Patients with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma at the 14th International Conference on Malignant Lymphoma beonemedicines.com ↗
The updated data demonstrate that BGB-3111 has a high overall response rate in CLL and SLL, independent of poor-risk molecular features. |
| 2016-12-05 | BeOne Medicines | Results BeiGene Presents Updated Clinical Data on BTK Inhibitor BGB-3111 in Patients with Waldenström’s Macroglobulinemia at the 2016 American Society of Hematology Annual Meeting beonemedicines.com ↗
The updated clinical data continue to demonstrate that BGB-3111 is well-tolerated and highly active in WM, with an overall response rate of 94%, including a major response rate of 78% and a very good partial response (VGPR) rate of 34%, at a median follow-up time of 9.6 months. |
| 2016-12-05 | BeOne Medicines | Results BeiGene Presents Updated Clinical Data on BTK Inhibitor BGB-3111 in Patients with Chronic Lymphocytic Leukemia and Small Lymphocytic Leukemia at the 2016 American Society of Hematology Annual Meeting beonemedicines.com ↗
The preliminary clinical data demonstrate that BGB-3111 is well-tolerated and highly active in CLL / SLL, with an overall response rate of 96%, and no cases of disease progression, at a median follow-up time of 8.6 months. |
| 2016-11-03 | BeOne Medicines | Results BeiGene Announces Oral Presentations on BTK Inhibitor BGB-3111 at the 2016 American Society of Hematology Annual Meeting beonemedicines.com ↗
High Major Response Rate, including Very Good Partial Responses (VGPR), in Patients (pts) with Waldenstrom Macroglobulinemia (WM) Treated with the Second Generation BTK Inhibitor BGB-3111: Expansion Phase Results from an Ongoing Phase I Study |
| 2016-10-07 | BeOne Medicines | Results BeiGene Presents Updated Clinical Data on BTK Inhibitor BGB-3111 in Patients with Waldenstrom’s Macroglobulinemia at 9th International Workshop on Waldenstrom’s Macroglobulinemia beonemedicines.com ↗
The updated data continue to show that BGB-3111 is well-tolerated and highly active in Waldenström's macroglobulinemia. |
| 2016-10-04 | BeOne Medicines | Results BeiGene to Host Conference Call on BGB-3111 Data Presentation at IWWM-9 beonemedicines.com ↗
The BTK Inhibitor, BGB-3111, is Tolerable and Highly Active in Patients with Waldenström’s Macroglobulinemia: Interim Data from an Ongoing Phase 1 First-in-Human Trial |
All press releases naming this drug 151 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 151 releases opens the full record — a long page | ||
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 210 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Zanubrutinib | “Using the combined regimen of CHiR (chidamide, zanubrutinib, and lenalidomide) to treat newly diagnosed elderly patients with MYC- and BCL2-expressing positive diffuse large...” NCT06764017 ↗203“Targeting Bruton's tyrosine kinase (BTK), the novel BTK inhibitor zanubrutinib (highly selective, low toxicity) combined with obinutuzumab (enhanced antibody-dependent...” NCT07165769 ↗ “Part A: This is a randomized, placebo-controlled, double blind, single dose study to evaluate the safety and tolerability of a single oral supratherapeutic dose of zanubrutinib...” NCT03432884 ↗ “Zanubrutinib, as a new generation of BTK inhibitors, has shown more potent antitumor activity and lower adverse reactions than ibrutinib in head-to-head clinical studies” NCT06890585 ↗ “Commercially available cBTKi (ibrutinib or acalabrutinib, or zanubrutinib) will be administered in accordance with its prescribing label.” NCT06524375 ↗ “Covalent BTK inhibitor (Ibrutinib 560 mg qd, Zanubrutinib 160 mg bid, or Orelabrutinib 150 mg qd) orally on Days 1-21.” NCT07350850 ↗ “Zanubrutinib: Oral administration starts on Day 1 of Cycle 1 and continues continuously at 160 mg twice daily.” NCT07259122 ↗ “Ibrutinib is the first-generation BTK inhibitror and Zanubrutinib is the second-generation BTK inhibitor.” NCT05020392 ↗ “5 cycles of R-CHOP combined with MTX + Zanubrutinib, followed by 1 cycle of R-MTX-Zanubrutinib” NCT06594432 ↗ “ME Type: Glofitamab + Local Radiotherapy + BTK inhibitor (e.g., Zanubrutinib)” NCT07602322 ↗ “Venetoclax 400 mg/d + Zanubrutinib 160 mg orally twice daily until cycle 21.” NCT05478512 ↗ |
| Known as | BGB- 3111 | “A Two-Part Phase 1 Study to Investigate A) Safety and Tolerability of Supratherapeutic dose of Zanubrutinib (BGB-3111) and B) Effect of Zanubrutinib on Cardiac Repolarization...” NCT03432884 ↗9“A Phase 1, Open-label, Single-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Zanubrutinib (BGB-3111) in Subjects With Varying Degrees of Hepatic Impairment” NCT03465059 ↗ “Zanubrutinib (BGB-3111, Brukinsa®, BeiGene) is a second-generation irreversible BTKi developed by Chinese company BeiGene.” NCT05922839 ↗ “The investigational medicinal products (IMP) are Zanubrutinib (BGB- 3111) and BGB-11417.” NCT06547866 ↗ “Zanubrutinib (BGB-3111)” NCT03206970 ↗ |
| Known as | Brukinsa | “Zanubrutinib (BGB-3111, Brukinsa®, BeiGene) is a second-generation irreversible BTKi developed by Chinese company BeiGene.” NCT05922839 ↗ |
| Known as | Zanu | “Participants in this group will receive combination therapy of Zanubrutinib (Zanu) and Tafasitamab (Tafa) for up to 24 cycles, followed by maintenance therapy with Zanubrutinib...” NCT06029309 ↗ |
| Known as | Zanubrutinib (BGB-3111) | “Zanubrutinib (BGB-3111)” NCT06558604 ↗ |
| Action | Inhibit | “Zanubrutinib is a more selective, next-generation BTK inhibitor.” PMID 38502198 ↗ May 2024 |
| Modality | Small molecule | “Zanubrutinib is an oral small molecule BTK inhibitor” NCT05164770 ↗ |
| Route | Oral | “Oral administration by capsule” NCT02343120 ↗ |
| Target | BTK | “Zanubrutinib is a more selective, next-generation BTK inhibitor.” PMID 38502198 ↗ May 2024 |