UBI集團訊息
Drug Holiday is not just a dream! United BioPharma announced positive result in UB-421 Phase II Clinical Trial
The results of the UB-421 Phase II Clinical Trial confirmed the role of UB-421 monotherapy as a potential substitution treatment for HAART therapy. Over a 16-week treatment period, UB-421 reached 100% inhibition to HIV viruses, showing superior efficacy in HIV/AIDS monoclonal antibody drug treatments. United BioPharma is proceeding to plan the Phase III Clinical Trial in Taiwan and the Asian region for UB-421 and will subsequently submit an application to the U.S. FDA for the Phase IIb Clinical Trial for indication of HAART substitution therapy and HAART failure. UBP will also submit the qualifying criteria application for breakthrough therapy and orphan drug designation for UB-421.
The UB-421 Phase II Clinical Trial showed a reduction in the number of T regulatory cells and an increase in the number of CD8 T cells (Cytotoxic T cells), indicating the T cell immunity of HIV patients could be potentially restored. The outcome of the trial showed UB-421 monotherapy was not only for the two indications of HAART substitution therapy and HAART failure, but provided a new study direction for AIDS functional cure and late-stage cancer therapy. The clinical data attracted high interest from AIDS research authority, Dr. Antony Fauci, and his NIAID scientific team who have invited UBP to collaborate with them further in studying UB-421 as a functional cure.
Based on the significant market potential of UB-421, United Biopharma has been authorized by UBI US Holdings LLC and UBI IP Holdings, the subsidiary of United Biomedical, Inc., Asia (the parent company of UBP), to acquire the exclusive right of UB-421 global business development for increasing the production value. UBP aims to accelerate the international clinical development in UB-421 indications by international authorization and strategic alliance, and to grab the USD$20 billion AIDS drug global market share, to provide new hope for HIV/AIDS patients.
About UBP (6471)
UBP was established in September 2013 as a spinoff from United Biomedical, Inc., Asia, and is strategically partnering with Formosa Plastics Group. UBP has an integrated monoclonal antibody drug development platform, and focuses on development, manufacturing, and marketing of innovative monoclonal antibody drugs and biosimilars. With a spirit of “innovation and practicality,” UBP is dedicated to addressing unmet medical needs, thereby improving the health of mankind and economic advancement of Taiwan. For more information, please visit http://www.unitedbiopharma.com
United BioPharma Forward-Looking Statements
The information in this press release should be considered accurate only as of the date of the release. UBP has no intention of updating and specifically disclaims any duty to update the information in this press release. The press release may contain forward-looking statements involving risks and uncertainties and UBP’s actual results may differ materially from those in the forward-looking statements.