Bowave Pharmaceuticals Announces NMPA Breakthrough Therapy Designation for BW-20507, a Novel siRNA Therapeutic for Chronic Hepatitis B

Today (June 11),Argo Biopharma Co., Ltd. (hereinafter referred to as "Argo Biopharma") announced that its self-developed Class 1 new drug, BW-20507, has been included in the breakthrough therapy designation by the National Medical Products Administration (NMPA) of China for...Treatment of Chronic Hepatitis B Virus (HBV) InfectionThis designation is based on the drug's significant antiviral activity and good safety profile demonstrated in early clinical trials, with the potential to provide patients with a better treatment option.BW-20507 is asiRNA drugs targeting Hepatitis B Virus (HBV).

In May 2025, Argo Biopharma presented the latest research data on BW-20507 in the Late-Breaker session at the European Association for the Study of the Liver (EASL) conference in the form of a poster. The study was conducted in Hong Kong, China, and Thailand, where the company showcased its remarkable efficacy in reducing hepatitis B surface antigen (HBsAg), achieving HBsAg clearance, and lowering hepatitis B virus DNA levels, drawing significant attention from experts. To date, no drug has demonstrated such notable therapeutic activity in clinical trials. The designation as a breakthrough therapy will further accelerate the clinical development process of this drug, promoting the early fulfillment of unmet treatment needs in the field of chronic hepatitis B.

Dr. Dongxu Shu, Founder and CEO of Argo Biopharma, stated: "The breakthrough therapy designation for BW-20507 marks another critical step forward in the company’s development of highly differentiated siRNA therapies to address unmet medical needs across multiple therapeutic areas. siRNA therapies have unique advantages in tackling the challenge of low functional cure rates for HBV. The breakthrough of BW-20507 once again demonstrates the efficient drug discovery capabilities of the company's RADSTM platform. We will work closely with regulatory agencies and clinical investigators to accelerate the advancement of subsequent clinical trials."

Globally, there are approximately 296 million people living with chronic hepatitis B virus (HBV) infection. Each year, around 820,000 individuals die from severe complications such as cirrhosis, hepatic decompensation, and hepatocellular carcinoma (HCC). Currently, there remains a significant unmet clinical need for the functional cure of chronic hepatitis B. Small nucleic acid drugs, which exert therapeutic effects by targeting viral mRNA, are expected to become a major breakthrough in achieving a functional cure.

Public information shows that Argo Biopharma is a clinical-stage biotechnology company dedicated to developing a new generation of RNAi therapies, providing better treatment options for patients worldwide. The company leverages its liver-targeting and extrahepatic delivery technology platforms to build a diversified RNAi drug R&D pipeline covering cardiometabolic diseases, specialty diseases, viral infections, central nervous system disorders, and rare diseases. Currently, Argo Biopharma has six RNAi candidate drugs in clinical research.

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