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BeOne Medicines (ONC)
NASDAQ:ONC
Bg-A3004
Skin Diseases
Phase I
Recruiting
A Study to Evaluate the Safety of BG-A3004 in Healthy Participants and Patients With Immune-Mediated Skin Diseases
Feb 09, 2026
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Oxaliplatin, Capecitabine, Cisplatin, Leucovorin, 5-Fluorouracil, 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
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: Bg-A3004, Venetoclax, Zanubrutinib, Acalabrutinib, Sonrotoclax, Fulvestrant, Bgb-43395, Bg-75098. These drug candidates are in various stages of clinical development as the company works toward FDA approval.