SHANGHAI, CHINA and BOSTON, USA – June 11, 2025—Argo Biopharmaceutical Co., Ltd. (Argo Biopharma), a clinical-stage small interfering RNA (siRNA) therapeutics company, today announced that its investigational drug BW-20507 has been granted Breakthrough Therapy Designation (BTD) by China Center for Drug Evaluation(CDE)， National Medical Products Administration (NMPA) for the treatment of chronic hepatitis B (CHB, chronic HBV) infection. This recognition is based on the molecule’s demonstrated potent antiviral activity and favorable safety profile in early-stage clinical trials, positioning it as a potential transformative therapy for HBV patients.
In May 2025, Argo Biopharma presented updated clinical data from BW-20507 at the European Association for the Study of the Liver Congress (EASL Congress) in a late-breaker poster presentation showcasing significant reduction of hepatitis B surface antigen (HBsAg) and HBV DNA levels in patients in Hong Kong (China) and Thailand. To date, no molecule has shown such robust therapeutic activity in clinical trials. The Breakthrough Therapy Designation will expedite the molecule’s clinical development, addressing the critical unmet need in achieving a functional cure for patients suffering from chronic HBV.
"BW-20507’s Breakthrough Therapy Designation marks a pivotal milestone in Argo’s mission to develop highly differentiated siRNA therapeutics for patients with unmet medical needs across multiple therapeutic areas. " said Dr. Dongxu Shu, Co-Founder and CEO of Argo Biopharma. "With HBV patients suffering from very low functional cure rates, siRNA-based therapeutics hold unique potential, and BW-20507 is another example of the ability of Argo’s RADSTM platform to discover highly differentiated molecules. We are committed to advancing this program in collaboration with global regulators and investigators."
About Chronic Hepatitis B (CHB)
Chronic HBV affects approximately 296 million individuals globally, resulting in an estimated 820,000 deaths each year due to complications including cirrhosis, liver decompensation, and hepatocellular carcinoma (HCC). Currently, there remains a significant unmet medical need for functional cure treatments for CHB. siRNA therapies, which target viral mRNA, represent a promising pathway to a functional cure.
About Argo Biopharma
Argo Biopharma is a clinical-stage biotechnology company committed to developing next-generation RNAi therapeutics to provide better treatment options for patients worldwide. The company has established a robust and diverse pipeline of RNAi drug candidates targeting a wide range of indications, including cardiovascular diseases, viral infections, metabolic conditions, and specialty/rare diseases. Currently, Argo Biopharma has six RNAi candidates in clinical development.
For more information, visit www.argobiopharma.com .
None
