AusperBio Secures China CDE Clearance for Phase III Clinical Trial of AHB-137 in Chronic Hepatitis B
Shanghai, China – July 21, 2025 – AusperBio, a pioneering biopharmaceutical company dedicated to developing innovative therapies for viral diseases, is pleased to announce that it has received clearance from the China Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to advance its investigational drug, AHB-137, into a Phase III clinical trial for the treatment of chronic hepatitis B (CHB).
This significant milestone marks a crucial step forward in the development of AHB-137, a novel therapeutic candidate with the potential to offer a new paradigm in the management of chronic hepatitis B. The CDE’s approval signifies their confidence in the safety and efficacy data gathered from earlier-stage clinical studies, paving the way for the comprehensive evaluation of AHB-137 in a larger patient population.
Chronic hepatitis B is a serious global health concern, affecting millions worldwide and posing a significant risk of liver cirrhosis, liver failure, and hepatocellular carcinoma. While current treatments have shown efficacy in managing the virus, there remains a critical unmet need for therapies that can achieve a functional cure or offer improved long-term outcomes. AusperBio’s AHB-137 is designed to address this need by targeting specific mechanisms involved in the hepatitis B virus lifecycle.
“We are incredibly encouraged by the CDE’s clearance to proceed with our Phase III clinical trial for AHB-137,” said [Insert Name and Title of AusperBio Spokesperson, e.g., Dr. Li Wei, CEO of AusperBio]. “This clearance is a testament to the hard work and dedication of our research and development teams, and it brings us closer to potentially offering a transformative treatment option to patients suffering from chronic hepatitis B in China and globally. We are eager to initiate the Phase III study and further assess the full potential of AHB-137.”
The upcoming Phase III clinical trial will be a multicenter, randomized, double-blind, placebo-controlled study designed to rigorously evaluate the safety and efficacy of AHB-137 in a diverse cohort of patients with chronic hepatitis B. The trial will aim to confirm the positive results observed in earlier studies and provide comprehensive data for regulatory submissions.
AusperBio remains committed to advancing the development of AHB-137 with the ultimate goal of improving the lives of individuals living with chronic hepatitis B. The company is working diligently to initiate the Phase III trial and looks forward to collaborating with clinical investigators and regulatory authorities to ensure its successful execution.
About AusperBio: AusperBio is a biopharmaceutical company focused on the discovery and development of innovative therapies for viral infections. With a strong emphasis on scientific rigor and patient-centricity, AusperBio is committed to addressing critical unmet medical needs in virology.
About AHB-137: AHB-137 is an investigational therapeutic candidate being developed for the treatment of chronic hepatitis B. Its novel mechanism of action is designed to target key pathways involved in viral replication and pathogenesis.
Forward-Looking Statements: This press release contains forward-looking statements regarding the development of AHB-137, including statements about the potential benefits, safety, and efficacy of the drug, as well as the timeline for clinical trials. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially. Risks and uncertainties include, but are not limited to, the results of clinical trials, the ability to obtain regulatory approvals, and competition from other therapies.
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PR Newswire Healthring published ‘AusperBio Receives China CDE Clearance to Advance AHB-137 into Phase III Clinical Trial for Chronic Hepatitis B’ at 2025-07-21 19:45. Please write a detailed article about this news in a polite tone with relevant information. Please reply in English with the article only.