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BeOne Medicines (ONC)
NASDAQ:ONC
Aromatase Inhibitor, Bg-75202, Cdk4 Inhibitor, Estrogen Receptor Antagonist
Breast Cancer, Advanced Solid Tumor
Phase I
Not Yet Recruiting
An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Solid Tumors
Oct 28, 2025
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Oxaliplatin, Capecitabine, Cisplatin, Leucovorin, 5-Fluorouracil (5-FU), Subcutaneous Tislelizumab, Intravenous Tislelizumab
Gastroesophageal Junction Adenocarcinoma, Metastatic Gastric Adenocarcinoma
Phase III
Recruiting
A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Jun 20, 2025
Rituximab, Bendamustine, Methylprednisolone, Bgb-16673
Small Lymphocytic Lymphoma, Chronic Lymphocytic Leukemia
Phase III
Recruiting
A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) Inhibitors
May 06, 2025
Rituximab, Venetoclax, Obinutuzumab, Sonrotoclax
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Phase III
Recruiting
A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL)
Apr 17, 2025
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does BeOne Medicines (ONC) have in its pipeline
ONC is currently developing the following drugs: Aromatase Inhibitor, Bg-75202, Cdk4 Inhibitor, Estrogen Receptor Antagonist, Bg-C0902, Zanubrutinib. These drug candidates are in various stages of clinical development as the company works toward FDA approval.