Clinical Trials

1. BEL-X Clinical Trial Pipeline

 新藥開發規畫(英)-20221118

2. Phase I clinical trial (completed)

Evaluation:A Phase I, Dose Escalation and Extension Study to Evaluate the Safety Tolerability and       Preliminary Effects of Oral BEL-X in Patients With AdvancedRefractory Solid Malignancies

IND:US FDA (#127857) & Taiwan FDA FDA、TFDA-20221123

Trial site:National Taiwan University Hospital  台大-20221123

National Cheng Kung University Hospital  成大-20221123

 

Period:2017.05-2020.04

Results:1. BEL-X showed safety and no serious side effects under the maximum tolerated dose of the      subject.

             2. It obtained significant effects on maintaining the body weight and quality of life of tested                    subjects.

  

3. Phase II Clinical Trial - Chronic Hepatitis B Treatment

Evaluation:A phase II adaptive design trial of BISQ-01 for HBeAg positive Chronic Hepatitis B

Status:File IND for US FDA and Taiwan FDA  in 1st half of  2023  FDA、TFDA-20221123

Start trial in 2023.

Target:Rapidly enhance the HBe seroconversion rate

Strength of Product:1.High quality, high safey

                                   2.Global patent protection

                                         3.The quality control from the raw material to the final product under global            regulations (PIC/S, cGMP)