UBI Pharma applies to the Taiwan Food and Drug Administration (TFDA) for drug inspection registration of the biosimilar drug erythropoietin UB-851.

Our company has completed the submission of the application for drug inspection registration of the biosimilar drug erythropoietin UB-851 to the Taiwan Food and Drug Administration (TFDA).

Erythropoietin is primarily used to treat renal anemia. According to Allied Market Research, the global erythropoietin (EPO) market reached $9.24 billion in 2020 and is estimated to reach $11.41 billion by 2028, with a compound annual growth rate (CAGR) of 5.7% from 2021 to 2028. According to IQVIA (IMS Health) database 2022 data, the global market for recombinant human erythropoietin is approximately $6.4 billion, with UB-851 targeting the market for short-acting erythropoietin, reaching $4.1 billion globally.

According to the "2022 Taiwan Kidney Disease Yearbook" issued by the National Health Research Institutes and the Taiwan Society of Nephrology, the prevalence of chronic kidney disease (CKD) dialysis patients in Taiwan was 88,880 in 2020, with an annual increase in dialysis prevalence of approximately 2%-3% from 2016 to 2020. The dialysis incidence rate in 2020 was 600 per million population (male) and 452 per million population (female), with 12,381 new dialysis patients in 2020, indicating an increasing trend. The prevalence of erythropoietin use in patients aged 20 and above before dialysis has increased, indicating a significant demand for erythropoietin use in the treatment of renal anemia and other conditions related to dialysis in the pharmaceutical market.