Evaluation:A Phase I, Dose Escalation And Extension Study To Evaluate The Safety, Tolerability And Preliminary Effects Of Oral BEL-X In Patients With Advanced Refractory Solid Malignancies
IND:US FDA (#127857) & Taiwan FDA
Trial site:National Taiwan University Hospital
National Cheng Kung University Hospital
Period:2017.05-2020.04
Results:
1.BEL-X showed excellent safety with no serious side effects under the maximum tolerated dose.
2.It obtained significant effects on maintaining the body weight and quality of life of participated subjects.
Evaluation:A Phase II Adaptive Design Trial Of BEL-X For HBeAg Positive Chronic Hepatitis B Treatment
Status:File IND for Both US FDA and Taiwan FDA in first half of 2023, and start trial after obtaining IND approvals
Goal:Rapidly enhance the HBe seroconversion rate
Strength of Product:
1.High quality, high safety (Low toxicity and low side effects)
2.Global patent Protectio
3.The Manufacturing and quality control of products followed by global regulations (PIC/S, cGMP)
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