UBI Pharma applies to the TFDA for drug inspection registration of the new compound drug NDF01 for the treatment of HIV infection.

Our company has completed the submission of the application for drug inspection registration of the new compound drug NDF01 for the treatment of HIV infection to the Taiwan Food and Drug Administration (TFDA).

According to data from the Centers for Disease Control, as of October 111, Taiwan has 44,670 people living with HIV. Our product, NDF01, can serve as a frontline treatment in the cocktail therapy for HIV. With a specific formulation, it is particularly suitable for patients co-infected with HIV and tuberculosis, estimated to be around 2,457 individuals. Based on the daily medication calculation per person, the potential market size of NDF01 in Taiwan exceeds NT$375 million annually.

According to the Ministry of Health and Welfare's Centers for Disease Control, the total annual drug treatment reimbursement exceeds NT$5 billion.

NDF01, the new compound drug for HIV developed by UBI Pharma, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. The bioequivalence study was conducted by MingBio Biotechnology, with 13 participants enrolled in a randomized, two-way crossover design over a 6-week period to compare the bioequivalence of NDF01 with the reference drug in terms of maximum blood concentration and total exposure. The results of the study analysis demonstrate that the pharmacokinetic parameters of the active ingredient of NDF01 meet the criteria for bioequivalence with the reference drug.