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AHB-137 gains Breakthrough Therapy Designation (BTD) from the NMPA based on Phase 1/Phase2a clinical trial data demonstrating safety and efficacy.
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BTD accelerates AHB-137's development and regulatory review, facilitating potential access for chronic hepatitis B patients.
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Chronic HBV affects 296 million people globally, with a rare cure and is the primary cause of liver cancer.
SAN FRANCISCO, July 10, 2024 /PRNewswire/ -- 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.
Bella Lu, Regulatory Affairs Director at AusperBio, underscored that the BTD provides AHB-137 with expedited review status by the CDE, enabling timely communication and accelerated approval to address critical clinical needs. BTD does not change product approval standards but significantly expedites the regulatory process.
" We are delighted by the NMPA's grant of Breakthrough Therapy Designation for AHB-137. This approval recognizes the promising clinical data collected to date and highlights the urgent need for substantial advancements in CHB treatment options," said Bella Lu. "The outstanding safety and efficacy results from our Phase 1/2a studies suggest that AHB-137 has the potential to improve upon current HBV therapies. With NMPA's support, we aim to accelerate AHB-137's development further."
About NMPA Breakthrough Therapy Designation
The Breakthrough Therapy Designation (BTD) is part of the recently revised Drug Registration Regulation, effective from July 1, 2020. The NMPA BTD program aims to accelerate the development and evaluation of medicines for serious or life-threatening diseases. This designation is granted based on preliminary clinical evidence indicating that the investigational therapy may offer substantial improvement over available therapies on at least one clinically significant endpoint. For a list of drugs granted BTD by NMPA, please click here.