TFDA Approves the Phase I Clinical Trial of the New Drug UB-852 Developed by UBI Pharma

TFDA Approves the Phase I Clinical Trial of the New Drug UB-852 Developed by UBI Pharma


Hui-Rong Du | PUBLISHED: June 10, 2019 at 1:14 p.m.Commercial Times

UBI Pharma (6562) announced that the TFDA has approved the phase I clinical trial of its innovative, long-acting recombinant human erythropoietin UB-852.

The main purpose of this clinical trial is to investigate the safety of this new drug in healthy subjects. The trial will last approximately 12 months.

Erythropoietin (EPO) is a glycoprotein hormone produced by the peritubular fibroblasts in the renal cortex, and its function is to regulate the production of red blood cells (RBC) in the body by inducing differentiation of the hematopoietic progenitor cells to red blood cells in the bone marrow.

EPO is primarily produced in the kidneys, and consequently patients with chronic renal disease usually suffer from anemia. Because the prevalence of chronic kidney failure is high, the market of dialysis is continuously expanding, directly resulting in the growth of the EPO market. UB-852 is a biologic prepared using genetic recombination technology and transgenic cells through multiple processes such as cell culture and protein purification.

UBI Pharma stated that EPO is a protein drug with a relatively high technological threshold; furthermore, the company developed UB-852 based on its solid experience in developing the first-generation EPO, UB-851, as well as its patented Polysaccharide-binding Fusion Protein Platform. UB-852 features many advantages: its high sialic acid content can delay the action of sialidase, reduce the in vivo decomposition rate of drugs, and achieve a longer half-life.

UB-852 has been proven to have better half-life and efficacy than other commercially available second-generation drugs in preclinical studies and animal disease models, thus giving patients a safer option for medication.

United BioPharma stated that the half-life of the first-generation EPO is short, and these products need to be administered three times a week, which will affect patients’ quality of life and cause inconvenience. In addition, for dialysis patients with anemia caused by pre-ESRD, cancer chemotherapy, or antiviral drugs for HIV, the demand for long-acting EPO drugs is even more pressing. The long-acting UB-852 is produced in Taiwan and preclinical studies have demonstrated its safety. At present, the process development and drug production for clinical use have been completed, and the TFDA has approved the implementation of the phase I clinical trial. This product is expected to provide a long-acting drug option for patients and hospitals after completion of its development and release. UB-852 will reduce the total amount of drugs administered and the frequency of medication, thus improving patients’ quality of life.