UBI Pharma Inc. (6562.TW) announced today (2) that the independently developed biosimilar drug Recombinant Human Erythropoietin (EPO) UB-851 has applied for drug inspection registration and Taiwanese drug certificates with the Taiwan Food and Drug Administration (TFDA) and the submission process has been completed.
According to UBIP, EPO is primarily used to treat renal anemia. According to statistics from Allied Market Research, the global EPO market reached $9.24 billion in 2020 and is estimated to reach $11.41 billion by 2028, with a compound annual growth rate of 5.7% from 2021 to 2028. According to IQVIA (IMS Health) data from 2022, 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.
Based on data from the “2022 Taiwan Kidney Disease Annual Report” issued by the National Health Research Institutes and the Taiwan Society of Nephrology, the prevalence of patients undergoing dialysis for chronic kidney disease in Taiwan was 88,880 in 2020. The prevalence rate of dialysis increased by approximately 2 to 3% annually from 2016 to 2020. In 2020, the incidence rate of dialysis was 600 men and 452 women per million population, with 12,381 new dialysis patients in the same year. The number showed an increasing trend. Among new dialysis patients aged 20 and above, there was an increase in the use of erythropoietin in the year before dialysis, indicating a significant demand for dialysis-related treatments such as renal anemia in the pharmaceutical market.
If UBIP UB-851 obtains Taiwanese drug certificates, it will become the first domestically-produced biosimilar erythropoietin drug, potentially addressing the issue of reliance on imported drugs or shortages domestically. This development is expected to meet the urgent needs of many kidney disease patients undergoing dialysis, support the Ministry of Health and Welfare in strengthening the mechanism for stable drug supply domestically, and benefit chronic kidney disease patients in Taiwan.
