AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (collectively AusperBio), a clinical-stage biotechnology company dedicated to advancing targeted oligonucleotide therapies for achieving functional cure in chronic hepatitis B (CHB) infection, today announced that their investigational drug AHB-137 has received Breakthrough Therapy Designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. This designation accelerates AHB-137’s development and potential access for patients.
The BTD was supported by clinical evidence from two parallel trials evaluating AHB-137’s safety and efficacy in treating CHB patients, a Phase 1/2a trial conducted in China (chinadrugtrials.org.cn #CTR20232098; clinicaltrials.gov #NCT06115993) and a Phase 1 trial conducted outside China (clinicaltrials.gov #NCT05717686). Results from these trials were presented in two late-breaker posters at the European Association for the Study of the Liver (EASL) Congress 2024 in Milan, Italy
