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  • News bot Oct. 2, 2025, 3:48 p.m.

    📋 BEIGENE, LTD. (BGNE) - Regulatory Update

    Filing Date: 2022-07-20

    Accepted: 2022-07-20 17:07:05

    Event Type: Regulatory Update

    Event Details:

    BeiGene Ltd (BGNE) Announces Regulatory Update BeiGene Ltd (BGNE) provided an update on regulatory developments for its product portfolio. Regulatory Update Details: None Clinical Development:

    🔬 Clinical Development Pipeline (BEIGENE, LTD.):

    Product Type Development Stage Therapeutic Area Source
    LBL-007 DRUG Phase PHASE1 Locally Advanced or Metastatic Solid Tumors for Phase 1,Dose Escalation and Phase 2 Safety Lead-in, HNSCC, NSCLC and RCC Participants for Phase 2 ClinicalTrials.gov
    Tislelizumab DRUG Phase PHASE1 Locally Advanced or Metastatic Solid Tumors for Phase 1,Dose Escalation and Phase 2 Safety Lead-in, HNSCC, NSCLC and RCC Participants for Phase 2 ClinicalTrials.gov
    BGB-A425 DRUG Phase PHASE1 Locally Advanced or Metastatic Solid Tumors for Phase 1,Dose Escalation and Phase 2 Safety Lead-in, HNSCC, NSCLC and RCC Participants for Phase 2 ClinicalTrials.gov
    Chemotherapy Doublet DRUG Phase PHASE2 Esophageal Cancer ClinicalTrials.gov
    5-Fluorouracil DRUG Phase PHASE1 Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer ClinicalTrials.gov
    Capecitabine DRUG Phase PHASE1 Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer ClinicalTrials.gov
    Bevacizumab or Bevacizumab biosimilar DRUG Phase PHASE1 Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer ClinicalTrials.gov
    BG-60366 DRUG Phase PHASE1 Non-Small Cell Lung Cancer ClinicalTrials.gov
    BGB-15025 DRUG Phase PHASE2 Non-Small Cell Lung Cancer ClinicalTrials.gov
    Ramucirumab DRUG Phase PHASE2 Non-Small Cell Lung Cancer ClinicalTrials.gov
    Docetaxel DRUG Phase PHASE2 Non-Small Cell Lung Cancer ClinicalTrials.gov
    BGB-A445 DRUG Phase PHASE2 Non-Small Cell Lung Cancer ClinicalTrials.gov
    rituximab DRUG Phase PHASE3 Mantle Cell Lymphoma; Non-Hodgkin Lymphoma ClinicalTrials.gov
    bendamustine DRUG Phase PHASE3 Mantle Cell Lymphoma; Non-Hodgkin Lymphoma ClinicalTrials.gov
    zanubrutinib DRUG Phase PHASE3 Mantle Cell Lymphoma; Non-Hodgkin Lymphoma ClinicalTrials.gov
    Fruquintinib DRUG Phase PHASE2 Minimal Residual Disease ClinicalTrials.gov
    BGB-16673 DRUG Phase PHASE1 B-cell Malignancy ClinicalTrials.gov
    Methylprednisolone DRUG Phase PHASE3 Chronic Lymphocytic Leukemia ClinicalTrials.gov
    Obinutuzumab DRUG Phase PHASE3 CLL ClinicalTrials.gov
    Venetoclax DRUG Phase PHASE3 CLL ClinicalTrials.gov
    Sonrotoclax DRUG Phase PHASE3 CLL ClinicalTrials.gov
    Idelalisib DRUG Phase PHASE3 CLL ClinicalTrials.gov
    Oxaliplatin DRUG Phase PHASE3 Metastatic Gastric Adenocarcinoma ClinicalTrials.gov
    5-fluorouracil (5-FU) DRUG Phase PHASE3 Metastatic Gastric Adenocarcinoma ClinicalTrials.gov
    Leucovorin DRUG Phase PHASE3 Metastatic Gastric Adenocarcinoma ClinicalTrials.gov
    Cisplatin DRUG Phase PHASE3 Metastatic Gastric Adenocarcinoma ClinicalTrials.gov
    Intravenous Tislelizumab DRUG Phase PHASE3 Metastatic Gastric Adenocarcinoma ClinicalTrials.gov
    Subcutaneous Tislelizumab DRUG Phase PHASE3 Metastatic Gastric Adenocarcinoma ClinicalTrials.gov
    Placebo DRUG Phase PHASE2 Rheumatoid Arthritis ClinicalTrials.gov
    BGB-45035 DRUG Phase PHASE2 Rheumatoid Arthritis ClinicalTrials.gov
    BGB-23339 DRUG Phase PHASE1 Not Determined ClinicalTrials.gov
    BGB-11417 DRUG Phase PHASE1 Acute Myeloid Leukemia ClinicalTrials.gov
    Posaconazole DRUG Phase PHASE1 Acute Myeloid Leukemia ClinicalTrials.gov
    Azacitidine DRUG Phase PHASE1 Acute Myeloid Leukemia ClinicalTrials.gov
    Glofitamab DRUG Phase PHASE1 B-cell Malignancy ClinicalTrials.gov
    Mosunetuzumab DRUG Phase PHASE1 B-cell Malignancy ClinicalTrials.gov
    Lenvatinib DRUG Phase PHASE3 Advanced Malignancies ClinicalTrials.gov
    Surzebiclimab DRUG Phase PHASE3 Advanced Malignancies ClinicalTrials.gov
    Zanidatamab DRUG Phase PHASE3 Advanced Malignancies ClinicalTrials.gov
    BAT1706 DRUG Phase PHASE3 Advanced Malignancies ClinicalTrials.gov
    Ociperlimab DRUG Phase PHASE3 Advanced Malignancies ClinicalTrials.gov
    Sitravatinib DRUG Phase PHASE3 Advanced Malignancies ClinicalTrials.gov
    Temozolomide DRUG Phase PHASE3 Advanced Malignancies ClinicalTrials.gov
    Pamiparib DRUG Phase PHASE3 Advanced Malignancies ClinicalTrials.gov
    Chemotherapy DRUG Phase PHASE1 Advanced Solid Tumor ClinicalTrials.gov
    BGB-26808 DRUG Phase PHASE1 Advanced Solid Tumor ClinicalTrials.gov
    BGB-C354 DRUG Phase PHASE1 Advanced Solid Tumor ClinicalTrials.gov
    BG-C9074 DRUG Phase PHASE1 Advanced Solid Tumor ClinicalTrials.gov
    BGB-43395 DRUG Phase PHASE1 Hormone-receptor-positive Breast Cancer ClinicalTrials.gov
    Fulvestrant DRUG Phase PHASE1 Hormone-receptor-positive Breast Cancer ClinicalTrials.gov
    BGB-21447 DRUG Phase PHASE1 Hormone-receptor-positive Breast Cancer ClinicalTrials.gov
    BG-68501 DRUG Phase PHASE1 Breast Cancer ClinicalTrials.gov
    Cetuximab DRUG Phase PHASE1 Metastatic Solid Tumors ClinicalTrials.gov
    BGB-53038 DRUG Phase PHASE1 Metastatic Solid Tumors ClinicalTrials.gov
    Lenalidomide DRUG Phase PHASE3 Relapsed/Refractory Follicular Lymphoma ClinicalTrials.gov
    BG-C477 DRUG Phase PHASE1 Advanced Solid Tumors ClinicalTrials.gov
    Standard of Care Therapy DRUG Phase PHASE1 Advanced Solid Tumor ClinicalTrials.gov
    BG-89894 DRUG Phase PHASE1 Advanced Solid Tumor ClinicalTrials.gov
    BGB-58067 DRUG Phase PHASE1 Advanced Solid Tumor ClinicalTrials.gov
    BGB-B2033 DRUG Phase PHASE1 Metastatic Hepatocellular Carcinoma ClinicalTrials.gov
    Nab paclitaxel DRUG Phase PHASE2 Non-small Cell Lung Cancer ClinicalTrials.gov
    Paclitaxel DRUG Phase PHASE2 Non-small Cell Lung Cancer ClinicalTrials.gov
    pemetrexed DRUG Phase PHASE2 Non-small Cell Lung Cancer ClinicalTrials.gov
    Carboplatin DRUG Phase PHASE2 Non-small Cell Lung Cancer ClinicalTrials.gov
    Tacrolimus DRUG Phase PHASE2 Primary Membranous Nephropathy ClinicalTrials.gov
    BGB-24714 DRUG Phase PHASE1 Solid Tumor, Adult ClinicalTrials.gov
    BGB-30813 DRUG Phase PHASE1 Advanced Solid Tumors ClinicalTrials.gov
    BG-C0902 DRUG Phase PHASE1 Solid Tumors ClinicalTrials.gov
    BGB-B455 DRUG Phase PHASE1 Advanced Solid Tumor ClinicalTrials.gov
    New Hormonal Agent DRUG Phase PHASE2 Prostate Cancer ClinicalTrials.gov
    Luteinizing Hormone Releasing Hormone DRUG Phase PHASE2 Prostate Cancer ClinicalTrials.gov
    Elacestrant DRUG Phase PHASE1 Advanced Solid Tumor ClinicalTrials.gov
    Letrozole DRUG Phase PHASE1 Advanced Solid Tumor ClinicalTrials.gov
    Phenytoin DRUG Phase PHASE1 Healthy Volunteers ClinicalTrials.gov
    Itraconazole DRUG Phase PHASE1 Healthy Volunteers ClinicalTrials.gov
    Drug: BG-T187 DRUG Phase PHASE1 Advanced Solid Tumor ClinicalTrials.gov
    BG-C137 DRUG Phase PHASE1 Advanced Solid Tumor ClinicalTrials.gov
    BGB-B3227 DRUG Phase PHASE1 Advanced Cancer ClinicalTrials.gov
    Pomalidomide DRUG Phase PHASE1 Relapsed/Refractory Multiple Myeloma ClinicalTrials.gov
    Daratumumab DRUG Phase PHASE1 Relapsed/Refractory Multiple Myeloma ClinicalTrials.gov
    Carfilzomib DRUG Phase PHASE1 Relapsed/Refractory Multiple Myeloma ClinicalTrials.gov
    Dexamethasone DRUG Phase PHASE1 Relapsed/Refractory Multiple Myeloma ClinicalTrials.gov
    Concurrent chemoradiotherapy (cCRT) DRUG Phase PHASE3 Carcinoma, Non-Small-Cell Lung ClinicalTrials.gov
    BGB-3111 DRUG Phase PHASE1 Healthy Volunteers ClinicalTrials.gov
    [14C]-BGB-3111 DRUG Phase PHASE1 Healthy Volunteers ClinicalTrials.gov
    BGB-3111 (Arm B) DRUG Phase PHASE1 Healthy Volunteers: Asian, Non-Asian ClinicalTrials.gov
    Rifampin DRUG Phase PHASE1 Healthy Volunteers: Asian, Non-Asian ClinicalTrials.gov
    BGB-3111 (Arm A) DRUG Phase PHASE1 Healthy Volunteers: Asian, Non-Asian ClinicalTrials.gov
    BGB-3111 and Drug Cocktail DRUG Phase PHASE1 Healthy Subjects ClinicalTrials.gov
    Moxifloxacin DRUG Phase PHASE1 Healthy Volunteers ClinicalTrials.gov
    BGB-B167 DRUG Phase PHASE1 Solid Tumors ClinicalTrials.gov
    Tislelizumab, AVD, Radiotherapy DRUG Phase PHASE2 Hodgkin Lymphoma ClinicalTrials.gov
    Hepatic arterial infusion chemotherapy PROCEDURE Phase PHASE1 Hepatocellular Carcinoma ClinicalTrials.gov
    Nocardia rubra cell wall skeleton DRUG Phase PHASE1 Hepatocellular Carcinoma ClinicalTrials.gov
    allo-HSCT PROCEDURE Phase PHASE2 Acute Myeloid Leukemia ClinicalTrials.gov
    Cytarabine DRUG Phase PHASE2 Acute Myeloid Leukemia ClinicalTrials.gov
    idarubicin/daunorubicin DRUG Phase PHASE2 Acute Myeloid Leukemia ClinicalTrials.gov
    Sorafenib DRUG Phase PHASE3 Hepatocellular Carcinoma (HCC) ClinicalTrials.gov
    Anlotinib DRUG Phase PHASE1 KRAS Mutation-Related Tumors ClinicalTrials.gov
    Trametinib DRUG Phase PHASE1 KRAS Mutation-Related Tumors ClinicalTrials.gov

    💼 Business Developments:

    No business developments data available.

    Structured Data:

    • Company Name: BeiGene Ltd
    • CIK: 0001651308
    • Ticker Symbol: BGNE
    • Period End Date: 2022-07-20
    • Document Type: 8-K

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