Dialysis Rate in Taiwan is the Highest Worldwide! The Phase III Trial of the EPO Injection Developed by UBI Pharma has been Completed, the Company Plans to Submit an Application for Drug Licensing to the TFDA

Dialysis Rate in Taiwan is the Highest Worldwide! The Phase III Trial of the EPO Injection Developed by UBI Pharma has been Completed, the Company Plans to Submit an Application for Drug Licensing to the TFDA

 

Bo-Yuan Fan | PUBLISHED: January 20, 2022 at 5:00 p.m.| Up Media

According to the 2020 Annual Report of the United States Renal Data System (USRDS), the incidence rate of end-stage renal disease (ESRD) and the prevalence rate of dialysis in Taiwan are both ranked first worldwide. Therefore, there is a huge demand for erythropoietin (EPO) in the dialysis-related pharmaceutical market. Trading of UBI Pharma Inc. stock (6562) was suspended today (January 20th), and the company announced the results of the end-of-stage data analysis of the phase III clinical trial of its erythropoietin biosimilar drug UB-851 at 2:00 PM in the Taipei Exchange. The analysis showed that the results met expectations.

The erythropoietin UB-851 developed by UBI Pharma is indicated for treating renal anemia. Chii-Hsiarng Chen, Chairman of UBI Pharma, said that hemodialysis patients usually need to receive dialysis three times a week, and erythropoietin injections, commonly known as EPO injections, can prevent the occurrence of anemia in patients. Furthermore, the administration of an EPO injection can delay the symptoms of anemia in patients with CKD stages 4 and 5 (ESRD).

This phase III clinical trial adopted a multiple dose, randomized, double blind and parallel design, with 204 enrolled subjects. The patients were assigned to the UB-851 and Eprex groups at a ratio of 2:1 to compare the safety, immunogenicity, and efficacy of maintaining the target hemoglobin levels. In addition, the safety and immunogenicity of UB-851 for long-term use during a period of 52 weeks were also assessed in the extension study.

According to the results of the phase III data analysis, in terms of clinical safety, no anti-erythropoietin antibodies were found in the UB-851 group, indicating that UB-851 is safe for long-term use and has no immunogenicity.

When compared with the reference drug Eprex (within the 95% confidence interval), the mean change in the hemoglobin level and the mean change in the weekly dose of erythropoietin (a common primary efficacy endpoint) were statistically significant, suggesting that treatment with UB-851 is equivalent to the Eprex treatment. No statistically significant differences were found between UB-851 and the reference drug in the frequency of blood transfusions and maintenance of hemoglobin levels in the subjects, indicating that the similarity defined in the trial design and statistics had been reached.

Chii-Hsiarng Chen, Chairman of UBI Pharma, said that the distribution of UB-851 will focus on Asia at first, and the company has signed agreements with several sales channels. The application for the BLA review of the drug will be submitted in the United States and the application for drug licensing will also be submitted to the Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare.

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