NASDAQ:BGNE

BriaCell Announces Clinical Supply Agreement with BeiGene for Bria-OTS™ First in Human Study

Retrieved on: 
Mardi, mai 28, 2024
BeiGene, Patient, Tislelizumab, Survival, Clinical trial, Therapy, Safety, Breast cancer, Prostate, Spacecraft, Cancer, CNS, Immunotherapy, TSX, Central nervous system, Pharmaceutical industry

Study to evaluate the effects of Bria-OTS™ in combination with anti-PD-1 antibody tislelizumab, in advanced, late stage, heavily pretreated metastatic breast cancer.

Key Points: 
  • Study to evaluate the effects of Bria-OTS™ in combination with anti-PD-1 antibody tislelizumab, in advanced, late stage, heavily pretreated metastatic breast cancer.
  • “We are extremely excited about partnering with BeiGene on this novel immunotherapy approach with planned expansion to prostate and other cancers,” stated Dr. William V. Williams, BriaCell’s President & CEO.
  • “In our randomized Phase 2 and other trials of Bria-IMT™, BriaCell immunotherapy has shown survival and clinical benefit in patients with central nervous system (CNS) metastases and after progression on antibody drug conjugates (ADCs).
  • BriaCell also plans to evaluate Bria-OTS™ in prostate and other cancers.

BRUKINSA® Data at ASCO Underscore Differentiated Clinical Profile for Treatment of CLL and SLL

Retrieved on: 
Vendredi, mai 24, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Patient, ASCEND, Chronic lymphocytic leukemia, Risk, Network, Clinical trial, University, Rituximab, PFS, Meta-analysis, Safety, Acalabrutinib, University of Washington, CLL, Blood, Abstract, Newsroom, ASCO, SLL, Associate, Lymphocytosis, BTK, Society, Hematology, BGNE, Survival, Annual general meeting, Pharmaceutical industry

“At this year’s ASCO, multiple presentations continue to add to our extensive body of evidence demonstrating BRUKINSA’s uniquely differentiated clinical profile,” Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene.

Key Points: 
  • “At this year’s ASCO, multiple presentations continue to add to our extensive body of evidence demonstrating BRUKINSA’s uniquely differentiated clinical profile,” Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene.
  • Results should be viewed in the context of analysis limitations and available randomized clinical trial data.
  • Data from this analysis provide important insights when evaluating the overall safety profile of individual BTKi treatments.
  • For additional information about BeiGene’s presence at the 2024 ASCO Annual Meeting, please visit our meeting hub in our newsroom .

BeiGene Highlights New Hematology Portfolio and Pipeline Data at EHA2024

Retrieved on: 
Mardi, mai 14, 2024
Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Science, Oncology, Patient, Chronic lymphocytic leukemia, Risk, MCL, TP53, CLL, CDAC, Blood, BCL2, Acalabrutinib, SLL, Non-Hodgkin lymphoma, Lymphocytosis, Abstract, BTK, Hematology, Mutation, BGNE, Quality of life, Pharmaceutical industry

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced it will share new data from its hematology portfolio and pipeline at the European Hematology Association 2024 Hybrid Congress (EHA2024) in Madrid, Spain, June 13-16, 2024.

Key Points: 
  • BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced it will share new data from its hematology portfolio and pipeline at the European Hematology Association 2024 Hybrid Congress (EHA2024) in Madrid, Spain, June 13-16, 2024.
  • BeiGene has 28 abstracts accepted at EHA2024, with four scheduled for oral presentations.
  • “As part of our dedication to bringing high-quality therapies to patients around the world, our presentations at EHA2024 underscore our continued commitment to expanding our hematology portfolio and our efforts to build on the success of BRUKINSA’s unique clinical profile across multiple B-cell malignancies,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene.
  • “The data highlight the potential of our differentiated investigational BCL2 inhibitor, sonrotoclax, as a monotherapy and in combination regimens, and the promise of BTK degradation to address the unmet needs of patients facing certain blood cancers.”
    Oral presentation of new data from an arm of the SEQUOIA study in patients with high-risk treatment-naïve (TN) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with del(17p) and/or TP53 mutation treated with BRUKINSA and venetoclax, demonstrating strong efficacy and favorable safety (Abstract S160)
    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)
    Presentation of a post hoc analysis evaluating the risk of developing hypertension among ALPINE trial participants with relapsed or refractory (R/R) CLL/SLL, which demonstrated patients in the ibrutinib arm initiated new and/or a new class of anti-hypertensive medications more frequently than patients in the BRUKINSA arm (Abstract P1836)
    Oral presentation of a Phase 1 study of BeiGene’s novel BCL2 inhibitor sonrotoclax (BGB-11417) in combination with BRUKINSA, demonstrating deep and durable responses with a tolerable safety profile in patients with R/R CLL/SLL; the combination of sonrotoclax with backbone therapy BRUKINSA is being evaluated in the randomized Phase 3 CELESTIAL study ( NCT06073821 ) in patients with TN CLL (Abstract S156)
    Poster presentation of Phase 1a/1b open-label dose escalation and expansion study of sonrotoclax in combination with BRUKINSA in R/R mantle cell lymphoma (MCL), showing the combination was generally well tolerated and demonstrated promising efficacy, including high rate of deep and durable responses (Abstract P1112)
    Additional presentations highlighting Phase 1 results for sonrotoclax, demonstrating encouraging response rates, durable responses and manageable safety profiles spanning multiple indications across B-cell and myeloid malignancies, including:
    Oral presentation of data from the ongoing, first-in-human Phase 1/2 study of BeiGene’s Bruton tyrosine kinase (BTK) degrader BGB-16673, highlighting tolerable safety and promising efficacy in heavily pretreated patients with R/R CLL/SLL ( NCT05006716 ); BGB-16673, which induces BTK degradation, is the first investigational drug from BeiGene’s chimeric degradation activation compound (CDAC) platform (Abstract S157)
    Additional data from the Phase 1/2 study of BTK CDAC BGB-16673, demonstrating a tolerable safety profile and preliminary efficacy in heavily pretreated patients with different types of non-Hodgkin lymphoma, including those with BTKi-resistant disease (Abstract P1119)

BeiGene Reports First Quarter 2024 Financial Results and Business Updates

Retrieved on: 
Mercredi, mai 8, 2024
Oncology, Health, Other Health, General Health, Pharmaceutical, Biotechnology, FDA, Obinutuzumab, Acalabrutinib, NMPA, Food, Sustainability, European Commission, Progression-free survival, Fulvestrant, MTA, ASCEND, ESCC, Patent, PDUFA, ADC, CLL, Patient, CDK4, Symantec Endpoint Protection, Chronic lymphocytic leukemia, HPK1, Tislelizumab, BLA, Anticipation, EGFR, NSCLC, CDK2, GAAP, Food and Drug Administration, Growth, Lung cancer, Pharmaceutical industry

Product Revenue for the three months ended March 31, 2024, was $747 million, compared to $410 million in the same period of 2023, representing an increase of 82%.

Key Points: 
  • Product Revenue for the three months ended March 31, 2024, was $747 million, compared to $410 million in the same period of 2023, representing an increase of 82%.
  • The increase in product revenue was attributable to increased sales of our internally developed products, BRUKINSA and tislelizumab.
  • Gross Margin as a percentage of global product revenue for the first quarter of 2024 was 83%, compared to 80% in the prior-year period.
  • The gross margin percentage increased primarily due to proportionally higher sales mix of global BRUKINSA compared to other products in the portfolio.

BeiGene Demonstrates Global Progress in 2023 Responsible Business & Sustainability Report

Retrieved on: 
Vendredi, avril 26, 2024
Environmental, Social and Governance (ESG), Green Technology, Climate Change, Sustainability, Pharmaceutical, Business, Oncology, Professional Services, General Health, Environment, Science, Biotechnology, Other Science, Health, Research, Responsibility, Cancer, Health equity, Woman, BGNE, Entrepreneurship, Patient, Global Health, Chronic lymphocytic leukemia, Tislelizumab, Carbon accounting, BTK

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, released its 2023 Responsible Business & Sustainability Report highlighting the Company’s strategy, the progress it has made towards existing goals, and how it intends to achieve its bold new targets.

Key Points: 
  • BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, released its 2023 Responsible Business & Sustainability Report highlighting the Company’s strategy, the progress it has made towards existing goals, and how it intends to achieve its bold new targets.
  • BeiGene’s Responsible Business & Sustainability Report highlights key achievements from 2023, including:
    Improved the percentage of women holding positions of Vice President and higher from 33% to 38% year over year.
  • “We are proud of the progress we’ve made on our priority areas in just a few short years,” said Christine Riley Miller, Global Head of Responsible Business & Sustainability at BeiGene.
  • We look forward to continuing our journey.”
    For more information about BeiGene’s Responsible Business & Sustainability strategy, achievements, and goals, please download a copy of the report here .

Global Oncology Innovator BeiGene Highlights New Data across Hematology and Solid Tumor Portfolio at 2024 ASCO Annual Meeting

Retrieved on: 
Mercredi, avril 24, 2024
Biotechnology, General Health, Health, Pharmaceutical, Oncology, Information, Acalabrutinib, Colorectal cancer, BCL2, Follicular lymphoma, Patient, Comparison, TIS, HPK1, Tislelizumab, Lymphoid leukemia, Pharmaceutical industry

Comparison of zanubrutinib (zanu) and acalabrutinib (acala) in B-cell malignancies: an adverse event (AE)-based analysis

Key Points: 
  • Comparison of zanubrutinib (zanu) and acalabrutinib (acala) in B-cell malignancies: an adverse event (AE)-based analysis
    Real-world evaluation of treatment pattern, time to next treatment (TTNT), healthcare resource utilization (HCRU), and cost of care in follicular lymphoma (FL)
    BGB-11417-203, an ongoing, phase 2 study of sonrotoclax (BGB-11417), a next-generation BCL2 inhibitor, in patients with Waldenström macroglobulinemia
    Session Type and Title: Poster Session – Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
    Preoperative (neoadjuvant) therapy with tislelizumab for locally advanced colorectal cancer with high microsatellite instability or deficient mismatch repair: an open-label, single-arm, multicenter phase II study
    Tislelizumab First-Line (1L) Gastric/Gastroesophageal Junction Cancer (G/GEJ) Treatment Efficacy on PRO-Based Symptom Endpoints Adjusting for Informative Missing Data Bias: Results from RATIONALE 305
    A first‑in‑human phase 1a dose‑escalation study of BGB‑15025 (HPK1 inhibitor) as monotherapy and in combination with tislelizumab (TIS; anti‑PD‑1 antibody) in patients (pts) with advanced solid tumors
    Long-term pooled safety analysis of tislelizumab as monotherapy or in combination with chemotherapy in patients with advanced cancers.

BeiGene Receives European Commission Approval for Tislelizumab as Treatment for Non-Small Cell Lung Cancer

Retrieved on: 
Mardi, avril 23, 2024
Biotechnology, Pharmaceutical, Health, Oncology, PFS, Patient, Paclitaxel, Hospital, Food, European Commission, Neutropenia, JAMA Oncology, Survival, BGNE, Tislelizumab, Docetaxel, ESCC, European, Disease, Journal, Pemetrexed, Leukopenia, Neoplasm, Civil service commission, Carboplatin, ALK, EGFR, NSCLC, European Medicines Agency, Overalls, Lung cancer, Pharmaceutical industry

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Commission (EC) has approved tislelizumab as a treatment for non-small cell lung cancer (NSCLC) across three indications, including first- and second-line use.

Key Points: 
  • BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Commission (EC) has approved tislelizumab as a treatment for non-small cell lung cancer (NSCLC) across three indications, including first- and second-line use.
  • “Today’s EC authorization marks the second in the region for tislelizumab, with both NSCLC and locally advanced or metastatic esophageal squamous cell carcinoma now approved in the European Union.
  • As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy.
  • Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.

BeiGene Receives FDA Approval for TEVIMBRA® for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Prior Chemotherapy

Retrieved on: 
Jeudi, mars 14, 2024
Cardiology, Biotechnology, Pharmaceutical, Oncology, General Health, Health, FDA, Clinical Trials, Civil service commission, Glucose, Survival, ALT, DSM-IV codes, Associate, Blas, Medicine, Patient, Esophageal cancer, Committee, Sodium, Alkaline phosphatase, University, Cancer, EMA, BGNE, Quality of life, Tislelizumab, Lung cancer, Section, European Medicines Agency, Lymphocyte, ITT, European Commission, Anemia, Division, ESCC, Fatigue, University of Southern California, BLA, Food, Pharmaceutical industry

TEVIMBRA will be available in the U.S. in the second half of 2024.

Key Points: 
  • TEVIMBRA will be available in the U.S. in the second half of 2024.
  • The FDA is also reviewing Biologics License Applications (BLAs) for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC and patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
  • BeiGene has launched more than 17 potentially registration-enabling trials with TEVIMBRA, of which 11 Phase 3 randomized trials and four Phase 2 trials have already had positive readouts.
  • More than 900,000 patients have been prescribed TEVIMBRA globally to date.

First Doses of BRUKINSA® provided to Patients with Chronic Lymphocytic Leukemia in Low- and Middle-Income Countries Under Collaboration of The Max Foundation, BeiGene, and the BeiGene Foundation

Retrieved on: 
Mercredi, mars 13, 2024
Oncology, Philanthropy, Health, Foundation, Pharmaceutical, Cardiology, Biotechnology, Diagnosis, Bone marrow, Chronic lymphocytic leukemia, Entrepreneurship, CLL, Health equity, Patient, Humanitarianism, Cancer, Leukemia, BeiGene, Access, Multimedia, Physician, Developing country, Medicine, Pharmaceutical industry

As a member of the Humanitarian PACT, BeiGene provided a monetary grant through the BeiGene Foundation and is providing BRUKINSA free of charge for eligible patients in a number of low- and middle-income countries.

Key Points: 
  • As a member of the Humanitarian PACT, BeiGene provided a monetary grant through the BeiGene Foundation and is providing BRUKINSA free of charge for eligible patients in a number of low- and middle-income countries.
  • “BeiGene and Max share a commitment to advance global health equity and ensure that patients in underserved regions have access to the best possible cancer care.
  • BeiGene and Max aim to provide access to CLL treatment to patients in need in 29 low- and middle-income countries.
  • Upon patient identity verification and CLL diagnosis confirmation, Max will deliver the treatment directly to the health institution providing care to the patient through well-established supply chains.

BeiGene Announces FDA Accelerated Approval of BRUKINSA for the Treatment of Relapsed or Refractory Follicular Lymphoma

Retrieved on: 
Jeudi, mars 7, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, BTK, PFS, Hematology, University, Food, Mantle cell lymphoma, BGNE, Lymphocytosis, Safety, MD Anderson Cancer Center, Chronic lymphocytic leukemia, Lymphoid leukemia, Malignancy, Obinutuzumab, Patient, IRC, Follicular lymphoma, Pharmaceutical industry

Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory MAHOGANY ( NCT05100862 ) trial, which is underway.

Key Points: 
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory MAHOGANY ( NCT05100862 ) trial, which is underway.
  • The application for R/R FL was also granted Fast Track Designation and Orphan Drug Designation by the FDA.
  • In a recent presentation, BRUKINSA showed sustained PFS benefit versus ibrutinib in a longer term follow up.
  • The global BRUKINSA development program includes more than 5,000 subjects enrolled to date in 29 countries and regions.