Bioequivalence Study is Completed for UBI Pharma’s New Formulation New Drug NDF01, and Will Proceed to NDA Filing Soon

UBI Pharma (Stock code: 6562) has completed the bioequivalence study and data analysis for its anti-HIV new formulation new drug NDF01. The filing for Taiwan NDA will be proceed soon.


According to data from Taiwan Center for Disease Control (CDC), there are 44,670 HIV patients by Oct. 2022. NDF01 can be used as first-line treatment for anti-HIV infection among many combination drugs in highly active antiretroviral therapy (HAART). Furthermore, NDF01 is more suitable for HIV and tuberculosis co-infection patients due to the composition of the drug. There are around 2,457 co-infection patients in Taiwan, and based on daily expenditure of the medication, the market value will be over 375 million NTD.


NDF01, developed by UBI Pharma as new formulation new drug, will be used for HIV-1 infection. The bioequivalence study was contracted to Mithra Biotechnology Inc. and the study design is open-label, randomized, crossover study, with 6 weeks study duration. Data from 13 subjects were analyzed to acquire the bioequivalence between NDF01 and the reference drugs in human. The indicators include maximum blood concentration (Cmax) and total body exposure (AUC). The results show that NDF01 and reference drug are bioequivalent in both indicators.


UBI Pharma state that the data analysis for new formulation new drug NDF01 is completed and will proceed to NDA filing to Food and Drug Administration Taiwan (TFDA) after the completion of detailed data analysis and drug manufacturing document.