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BeOne Medicines
(NASDAQ:ONC)
BeOne Medicines (ONC) vs. SPDR S&P 500 ETF (SPY)
BeOne Medicines Business Overview & Revenue Model
BeOne Medicines Earnings Call Summary
BeOne Medicines Financial Statement Overview
| Breakdown | TTM | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 4.97B | 3.81B | 2.46B | 1.42B | 1.18B | 308.87M |
| Gross Profit | 4.29B | 3.22B | 2.08B | 1.13B | 1.01B | 238.22M |
| EBITDA | 301.34M | -396.44M | -1.12B | -1.72B | -1.39B | -1.63B |
| Net Income | 68.55M | -644.79M | -881.71M | -2.00B | -1.46B | -1.62B |
Balance Sheet | ||||||
| Total Assets | 7.63B | 5.92B | 5.81B | 6.38B | 8.54B | 5.60B |
| Cash, Cash Equivalents and Short-Term Investments | 4.04B | 2.63B | 3.17B | 4.53B | 6.62B | 4.65B |
| Total Debt | 1.02B | 1.08B | 930.18M | 596.67M | 694.64M | 561.96M |
| Total Liabilities | 3.50B | 2.59B | 2.27B | 2.00B | 2.40B | 1.73B |
| Stockholders Equity | 4.13B | 3.33B | 3.54B | 4.38B | 6.13B | 3.87B |
Cash Flow | ||||||
| Free Cash Flow | 464.60M | -669.77M | -1.75B | -1.97B | -1.61B | -1.51B |
| Operating Cash Flow | 785.39M | -140.63M | -1.16B | -1.50B | -1.30B | -1.28B |
| Investing Cash Flow | -331.43M | -548.35M | 60.00M | 1.08B | 640.66M | -3.17B |
| Financing Cash Flow | 958.00M | 193.45M | 416.48M | -18.97M | 3.64B | 5.20B |
BeOne Medicines Technical Analysis
BeOne Medicines Risk Analysis
BeOne Medicines Peers Comparison
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
79 Outperform | $21.20B | 22.36 | 13.69% | 1.68% | 13.74% | 14.87% | |
74 Outperform | $25.72B | 15.99 | 9.31% | ― | 5.00% | -1.03% | |
69 Neutral | $40.09B | 640.07 | 1.84% | ― | 49.80% | ― | |
63 Neutral | $28.74B | 40.45 | 10.77% | ― | -0.25% | ― | |
53 Neutral | $12.05B | ― | -292.49% | ― | ― | -348.63% | |
53 Neutral | $23.21B | ― | -2.94% | ― | 7.04% | -25.24% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% |
BeOne Medicines Corporate Events
BeOne Medicines Ltd. is a global oncology company focused on developing innovative cancer treatments, with a strong presence in hematology and solid tumors. In its third-quarter 2025 earnings report, BeOne Medicines reported a significant increase in total revenues, reaching $1.4 billion, a 41% rise compared to the same period in 2024, driven primarily by the robust sales of its leading product, BRUKINSA. The company’s financial performance was marked by a notable improvement in net income, with GAAP net income reaching $125 million, a substantial turnaround from a loss in the previous year. Key highlights include a 51% increase in BRUKINSA revenues and a strong gross margin of 85.9%, reflecting the product’s growing market share and production efficiencies. Looking ahead, BeOne Medicines remains optimistic about its growth prospects, with expectations for continued revenue expansion and strategic investments in its oncology pipeline to drive long-term value.
BeiGene, Ltd. recently held its earnings call, revealing a strong financial performance and a positive outlook. The company reported record revenue growth and significant achievements in research and development, despite facing challenges in competitive markets and delays in some studies. Overall, the sentiment expressed during the call was optimistic, with highlights outweighing the lowlights.
Study Overview: BeOne Medicines is conducting a Phase 1a/1b clinical study titled A Phase 1a/1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-75202, Alone and in Combination With Other Agents in Patients With Advanced Solid Tumors. The study aims to assess the safety and preliminary antitumor activity of BG-75202, a KAT6A/B inhibitor, in patients with breast cancer and other advanced solid tumors.
BeOne Medicines (ONC) is currently conducting a Phase 1 clinical study titled ‘A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BG-T187, an EGFR×MET Trispecific Antibody, Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid Tumors.’ The study aims to evaluate the safety and effectiveness of BG-T187, a novel trispecific antibody, in treating advanced solid tumors, marking a significant step in cancer treatment research.
BeOne Medicines (ONC) is currently conducting a Phase 1b/2 clinical study titled A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma. The study aims to evaluate the safety, tolerability, and efficacy of sonrotoclax, both as a standalone treatment and in combination with other drugs, for patients with relapsed/refractory multiple myeloma and chromosomal translocation t(11;14). This research is significant as it could offer new therapeutic options for a challenging condition.
BeOne Medicines (ONC) is currently conducting a Phase 3 clinical study titled ‘A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Patients With Previously Untreated Chronic Lymphocytic Leukemia.’ The study aims to evaluate the efficacy of the combination of sonrotoclax and zanubrutinib versus venetoclax and obinutuzumab in treating chronic lymphocytic leukemia (CLL), which is significant for improving treatment options for this condition.
BeOne Medicines (ONC) is conducting a Phase 3 study titled ‘A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator’s Choice in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both BTK and BCL2 Inhibitors.’ The study aims to evaluate the efficacy and safety of BGB-16673 compared to standard treatments in patients with CLL or SLL who have previously been treated with BTK and BCL2 inhibitors. This study is significant as it explores new treatment avenues for patients with limited options.
BeOne Medicines (ONC) is currently conducting a Phase 4 observational study titled ‘A Phase 4, Observational Study Evaluating the Efficacy and Safety of the Bruton Tyrosine Kinase (BTK) Inhibitor Zanubrutinib in Patients With Waldenström Macroglobulinemia.’ The study aims to assess the clinical profile of zanubrutinib in patients with Waldenström macroglobulinemia (WM), focusing on efficacy and safety across different genetic mutations and ethnic groups.
BeOne Medicines (ONC) is currently conducting a Phase 3 clinical study titled A Phase 3, Multi-Center, Randomized, Open-Label Clinical Study of Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma. The study aims to evaluate the effectiveness of tislelizumab, administered either as a subcutaneous injection or intravenous infusion, combined with chemotherapy in treating advanced gastric or gastroesophageal junction adenocarcinoma. This research is significant as it explores alternative administration methods that could improve patient outcomes.
Study Overview: BeOne Medicines is conducting a Phase 1/2 open-label study titled ‘A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.’ The study aims to establish the safety of new dosing schedules for sonrotoclax in patients with hematological malignancies, specifically targeting chronic lymphocytic leukemia (CLL). This research is significant as it seeks to optimize treatment regimens, potentially improving patient outcomes.
BeOne Medicines is conducting a clinical study titled A Phase 1b/2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies. The study aims to evaluate the safety, preliminary antitumor activity, pharmacokinetics, and pharmacodynamics of BGB-16673 in combination with other agents, focusing on relapsed or refractory B-cell malignancies. This study is significant as it explores new treatment combinations for challenging cancer types.
Study Overview: The clinical study titled A Phase 3 Randomized, Open-Label Multicenter Study of Zanubrutinib (BGB-3111) Plus Anti-CD20 Antibodies Versus Lenalidomide Plus Rituximab in Patients With Relapsed/Refractory Follicular or Marginal Zone Lymphoma aims to evaluate the efficacy of zanubrutinib combined with anti-CD20 antibodies compared to lenalidomide plus rituximab in treating relapsed/refractory follicular and marginal zone lymphoma. The study’s primary goal is to measure progression-free survival, providing crucial insights into better treatment options for these conditions.
BeOne Medicines is currently recruiting participants for a Phase 1 clinical study titled A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-21447 (a Bcl-2 Inhibitor) Combinations for Patients With HR+/HER2- Metastatic Breast Cancer. The study aims to evaluate the safety and tolerability of BGB-21447, a Bcl-2 inhibitor, in combination with fulvestrant, with or without BGB-43395, in adults with hormone-receptor-positive, HER2-negative metastatic breast cancer.
BeOne Medicines (ONC) is currently conducting a Phase 3 study titled ‘A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.’ The study aims to evaluate the effectiveness of sonrotoclax combined with obinutuzumab or rituximab against venetoclax plus rituximab in treating adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The significance of this study lies in its potential to improve treatment outcomes for patients with these conditions.
BeOne Medicines is currently conducting a clinical study titled ‘A Phase 1/2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase Targeted Protein Degrader BGB-16673 in Patients With B-Cell Malignancies.’ The study aims to determine the optimal dosing and evaluate the safety and efficacy of BGB-16673, a drug targeting B-cell malignancies, including various forms of lymphoma and leukemia. This research is significant as it explores new treatment avenues for patients with these challenging conditions.
Amgen Inc, in collaboration with BeOne Medicines, is conducting a Phase 1b study titled ‘A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Subcutaneous Tarlatamab in Subjects With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)’. The primary aim is to assess the safety and tolerability of subcutaneous tarlatamab in patients with extensive stage small cell lung cancer, a critical area of unmet medical need.
BeOne Medicines is conducting a study titled ‘A Phase 2/3, Multicenter, Randomized, Active-Controlled, Open-label Study to Evaluate the Efficacy and Safety of Zanubrutinib in Patients With Primary Membranous Nephropathy.’ The study aims to assess the effectiveness of zanubrutinib in reducing proteinuria and achieving complete remission in patients with primary membranous nephropathy (PMN) who are receiving optimal supportive care.
BeOne Medicines is conducting a Phase 3 clinical study titled ‘A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.’ The study aims to assess the efficacy and safety of BGB-16673 against pirtobrutinib in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously been treated with a covalent Bruton tyrosine kinase inhibitor.
Study Overview: The clinical study titled A Phase 1a/1b Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-53038 aims to evaluate the safety and effectiveness of BGB-53038, a pan-KRAS inhibitor. This study is significant as it targets advanced or metastatic solid tumors with KRAS mutations or amplifications, which are notoriously challenging to treat.
Study Overview: BeOne Medicines (ONC) is conducting a Phase 1, open-label study titled ‘A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors.’ The study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-B455 in patients with advanced or metastatic solid tumors expressing claudin 6 (CLDN6). This study is significant as it seeks to establish a recommended dosing regimen and assess potential side effects, offering hope for new treatment options for these challenging conditions.
BeOne Medicines (ONC) is currently conducting a Phase 1 clinical study titled ‘A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B2033, Alone or in Combination With Tislelizumab, in Participants With Selected Advanced or Metastatic Solid Tumors.’ The study aims to evaluate the safety and effectiveness of BGB-B2033, both alone and in combination with Tislelizumab, in treating advanced or metastatic solid tumors, including hepatocellular carcinoma and other specific cancers. The significance of this study lies in its potential to identify a recommended Phase 2 dose for future research.
Amgen Inc., in collaboration with BeiGene and BeOne, is conducting a Phase 1 clinical study titled ‘A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer.’ The study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of AMG 509, both as a monotherapy and in combination with other drugs, in patients with metastatic castration-resistant prostate cancer (mCRPC).
Study Overview: BeOne Medicines (ONC) is conducting a Phase 1 clinical study titled A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HPK1 Inhibitor BGB-26808 Alone or in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors. The study aims to evaluate the safety and effectiveness of BGB-26808, alone or with Tislelizumab, in treating advanced solid tumors, which could significantly impact cancer treatment protocols.
Study Overview: BeOne Medicines (ONC) is conducting a Phase 1a/1b open-label study titled ‘Phase 1a/1b, Open-Label Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of a CDAC Degrading EGFR, BG-60366, in Patients With EGFR-Mutant Non-Small Cell Lung Cancer.’ The study aims to evaluate the safety, tolerability, and antitumor activity of BG-60366, a targeted therapy for patients with advanced or metastatic EGFR-mutant non-small cell lung cancer (NSCLC).
BeOne Medicines (ONC) has announced an update on its Phase 1a/b clinical study titled A Phase 1a/b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of PRMT5 Inhibitor BGB-58067 Alone and in Combination With Anticancer Agents in Patients With Advanced Solid Tumors. The study aims to evaluate the safety and preliminary antitumor activity of BGB-58067, both as a standalone treatment and in combination with other anticancer agents, for patients with advanced solid tumors exhibiting MTAP deficiency.
Study Overview: BeOne Medicines (ONC) is conducting a clinical study titled A Phase 1b/2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies. The study aims to assess the safety, tolerability, and preliminary efficacy of BGB-11417, both as a standalone treatment and in combination with azacitidine, for patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The significance lies in potentially offering new treatment avenues for these serious conditions.
BeOne Medicines (ONC) has announced a significant update on their clinical study titled ‘A Multicenter, Open-Label, Phase 1a/b First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C477 in Patients With Selected Advanced Solid Tumors.’ The study aims to evaluate the safety and preliminary antitumor activity of BG-C477, a drug intended for patients with advanced solid tumors, marking a crucial step in cancer treatment research.
Study Overview: The study titled A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma aims to evaluate the efficacy and safety of the combination of sonrotoclax and zanubrutinib compared to a placebo with zanubrutinib in adults with relapsed/refractory mantle cell lymphoma (MCL). This research is significant as it seeks to improve treatment outcomes for patients with this challenging condition.
BeOne Medicines (ONC) is conducting a clinical study titled An Open-Label, Multicenter, Long-Term Extension Study of Treatment With Tislelizumab, Pamiparib, and Other Investigational Agents in Patients With Advanced Malignancies. The study aims to evaluate the long-term safety and efficacy of several investigational drugs in patients with advanced malignancies who have participated in a previous BeiGene-sponsored study. This research is significant as it could lead to new treatment options for advanced cancer patients.
Study Overview: BeOne Medicines (ONC) is conducting a Phase 1a/b study titled A Phase 1a/b, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C137, an Antibody-Drug Conjugate Targeting FGFR2b, in Patients With Advanced Solid Tumors. The study aims to evaluate the safety and preliminary antitumor activity of BG-C137 in patients with advanced solid tumors, marking a significant step in oncology treatment research.
BeOne Medicines (ONC) is currently recruiting participants for a Phase 3 study titled A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator’s Choice in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent BTK Inhibitors. The study aims to evaluate the efficacy and safety of BGB-16673 against standard treatment options in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously been treated with covalent Bruton tyrosine kinase inhibitors (cBTKi).
BeOne Medicines (ONC) has announced an update on its ongoing clinical study titled ‘A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of BGB-16673 in Patients With Chronic Spontaneous Urticaria.’ The study aims to assess the safety and effectiveness of BGB-16673, a promising treatment for chronic spontaneous urticaria (CSU), a condition characterized by persistent hives without an apparent cause.
BeOne Medicines (ONC) is conducting a groundbreaking Phase 1a/1b study titled ‘A Phase 1a/1b Study of BG-68501, a Selective CDK2 Inhibitor, in Participants With Advanced Solid Tumors.’ The study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-68501 in patients with advanced solid tumors. This research is significant as it seeks to identify a recommended dose for expansion, potentially leading to new treatment options for various cancers.
Study Overview: BeOne Medicines is conducting a Phase 2 study titled ‘A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BGB-45035 Versus Placebo in Patients With Moderate to Severe Active Rheumatoid Arthritis.’ The study aims to assess the effectiveness of BGB-45035 in adults with moderate to severe rheumatoid arthritis who have not responded adequately to existing treatments. This research is significant as it seeks to provide a new therapeutic option for patients with limited treatment success.
Study Overview: BeOne Medicines (ONC) is currently conducting a Phase 1a/1b clinical study titled ‘Phase 1a/1b Study of BG-C9074, an Antibody Drug Conjugate Targeting B7H4, as Monotherapy and in Combination With Tislelizumab in Participants With Advanced Solid Tumors.’ The study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-C9074, both alone and in combination with Tislelizumab, in patients with advanced solid tumors. This study is significant as it explores new treatment avenues for challenging cancer cases.
BeOne Medicines (ONC) has announced a significant update on its ongoing clinical study titled ‘A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BGB-C354, an Antibody-Drug Conjugate Targeting B7H3, Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors.’ The study aims to assess the safety and initial effectiveness of BGB-C354, both as a standalone treatment and in combination with Tislelizumab, for patients with advanced solid tumors.
BeOne Medicines (ONC) has announced a new clinical study titled ‘A First-in-Human Study of BG-C0902 Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid Tumors.’ The study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-C0902, an antibody-drug conjugate targeting EGFR and MET, in patients with advanced solid tumors. This study is significant as it explores a novel treatment approach for challenging cancer cases.
BeOne Medicines (ONC) is conducting a pivotal study titled A Multicenter, Open-label, Phase 1a/1b Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B3227 as Monotherapy and in Combination With Tislelizumab in Patients With Advanced or Metastatic Solid Tumors. The study aims to evaluate the safety and effectiveness of BGB-B3227, alone and with Tislelizumab, in treating advanced or metastatic solid tumors. This research is significant as it explores new treatment avenues for challenging cancer types.
BeOne Medicines (ONC) has initiated a Phase 1a/1b clinical study titled ‘A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+/HER2- Breast Cancer and Other Advanced Solid Tumors.’ The study aims to evaluate the safety and efficacy of BGB-43395, a CDK4 inhibitor, in treating hormone receptor-positive and HER2-negative breast cancer, along with other advanced solid tumors. The primary goal is to determine the recommended dosing for BGB-43395.
BeOne Medicines (ONC) has initiated a Phase 1a/1b clinical study titled Phase 1a/1b Randomized Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and Its Safety and Tolerability in Patients With Autoimmune Dermatological Diseases. The study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGB-45035, a novel drug, in both healthy individuals and adults with autoimmune dermatological conditions such as atopic dermatitis and prurigo nodularis.
BeOne Medicines (ONC) is currently conducting a clinical study titled A Phase 1/1b Open-Label Dose-Escalation and Dose-Optimization Study of Bcl-2 Inhibitor BGB-21447 in Patients With Mature B-Cell Malignancies. The study aims to assess the safety and tolerability of BGB-21447 in patients with relapsed or refractory non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The primary goal is to establish the maximum tolerated dose, maximum administered dose, recommended Phase 2 dose, and pharmacokinetic profile, while also evaluating preliminary antitumor activity.
Study Overview: The study titled A Phase 4, Single-Arm, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Patients With Treatment-Naive Waldenström Macroglobulinemia aims to assess the effectiveness and safety of zanubrutinib in Chinese adults newly diagnosed with Waldenström Macroglobulinemia. This research is significant as it seeks to meet post-marketing requirements set by the National Medical Products Administration (NMPA).
Study Overview: The study titled ‘A Phase 1, Open-label, Fixed-sequence, Crossover Study to Investigate the Effect of Coadministration of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-16673 in Healthy Participants’ aims to explore how phenytoin and itraconazole affect the absorption and elimination of BGB-16673 in the body. This research is significant as it could influence future treatment protocols involving BGB-16673.
Amgen Inc., in collaboration with BeiGene, is conducting a Phase 1/2 clinical study titled ‘A Phase 1/2 Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Adults and Adolescents With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL) and Minimal Residual Disease Positive (MRD+) B-ALL.’ The study aims to evaluate the safety, efficacy, and pharmacokinetics of subcutaneous blinatumomab in treating R/R B-ALL and MRD+ B-ALL, which are challenging forms of leukemia.
Study Overview: BeOne Medicines is conducting a Phase 1 clinical study titled ‘A Phase 1, Single-dose, Open-label, Randomized, Crossover Study in Healthy Adult Participants to Evaluate Relative Bioavailability and Food Effect of a Fixed-Dose Combination Tablet Containing Zanubrutinib and Sonrotoclax (BG-71332)’. The study aims to assess the bioavailability of a new combination tablet compared to separate administration of its components, and how food affects its absorption. This research is significant as it may lead to more efficient drug delivery methods.
Study Overview: BeOne Medicines is conducting a Phase 1 study titled A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-89894 (SYH2039) Tablets in Patients With Advanced Solid Tumors. The study aims to assess the safety and tolerability of BG-89894, a new drug for treating advanced or metastatic MTAP-deleted solid tumors. This research is significant as it may guide future cancer treatment studies.
BeOne Medicines (ONC) is currently conducting a significant Phase 3 clinical study titled ‘A Phase 3, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study of Either Cisplatin or Carboplatin +Gemcitabine + Tislelizumab Compared With Either Cisplatin or Carboplatin + Gemcitabine + Placebo as First-line Treatment for Patients With Locally Advanced or Metastatic Urothelial Carcinoma.’ The study aims to evaluate the efficacy and safety of combining Tislelizumab with chemotherapy versus chemotherapy alone in treating urothelial carcinoma, a type of bladder cancer. This study holds importance as it explores potential improvements in treatment options for patients who have not received prior systemic therapy.
Study Overview: The clinical study titled A Phase 1/2, Open-Label, Dose-Escalation and Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Chinese Patients With B-Cell Malignancies aims to determine the recommended phase 2 dose and assess the safety, tolerability, and preliminary antitumor activity of BGB-16673. This study is significant as it targets various B-cell malignancies, including Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia, potentially offering new treatment avenues.
BeOne Medicines (ONC) has announced an update on its MORNINGSTAR study, officially titled ‘A Phase 1, Open-Label, Dose Escalation and Expansion Study of Mavrostobart (PT199) Administered Alone in Adult Patients with Advanced Solid Tumors, in Combination with a Checkpoint Inhibitor Treating Wild-type Non-Small Cell Lung Cancer, or in Combination with Chemotherapy for Metastatic or Advanced Pancreatic Ductal Adenocarcinoma.’ The study aims to evaluate the safety, tolerability, and preliminary efficacy of Mavrostobart (PT199), an anti-CD73 monoclonal antibody, alone and in combination with a PD-1 inhibitor or chemotherapy.
BeOne Medicines (ONC) is conducting a Phase 1 clinical study titled ‘A Multicenter Open-Label Phase 1a/1b Study to Evaluate the Safety and Preliminary Antitumor Activity of BGB-R046 as Monotherapy and in Combination With Tislelizumab in Participants With Selected Advanced or Metastatic Solid Tumors.’ The study aims to assess the safety, tolerability, and preliminary antitumor activity of BGB-R046, both alone and with tislelizumab, in treating advanced or metastatic solid tumors.
Study Overview: BeOne Medicines (ONC) is conducting a Phase 2 study titled A Single-Arm, Multi-Center, Open-Label, Phase 2 Study to Evaluate Efficacy and Safety of Tislelizumab (BGB-A317), an Anti-PD-1 Monoclonal Antibody, as Monotherapy in Patients With Previously-Treated Locally Advanced Unresectable or Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors. The study aims to assess the efficacy and safety of Tislelizumab in treating these specific types of solid tumors, which are significant due to their challenging nature and limited treatment options.
Study Overview: BeOne Medicines is conducting a Phase 2 clinical study titled An Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of the BCL2 Inhibitor Sonrotoclax (BGB-11417) as Monotherapy and in Combination With Zanubrutinib (BGB-3111) in Patients With Waldenström Macroglobulinemia. The study aims to assess the efficacy and safety of sonrotoclax, both as a standalone treatment and in combination with zanubrutinib, for patients with various stages of Waldenström Macroglobulinemia (WM). This research is significant as it explores new treatment avenues for patients with relapsed or refractory WM.