Bowave Pharmaceuticals Receives NMPA Breakthrough Therapy Designation for BW-20507 in Chronic Hepatitis B

Argo Biopharma Treats SlowChronic Hepatitis BNew DrugBW-20507Granted Breakthrough Therapy Designation by the National Medical Products Administration (NMPA)

Shanghai, China and Boston, USA — June 11, 2025—— Argo Biopharma Co., Ltd. (hereinafter referred to as "Argo Biopharma," or "the Company") announced that its self-developed novel drug BW-20507 has received Breakthrough Therapy Designation from the China National Medical Products Administration (NMPA) for the treatment of chronic hepatitis B virus (HBV) infection. This designation is based on the drug's significant antiviral activity and favorable safety profile demonstrated in early clinical trials, offering the potential for an improved treatment option for patients.

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 Europe via a poster presentation. The study was conducted in Hong Kong, China, and Thailand. At the conference, the company showcased its remarkable efficacy in reducing hepatitis B surface antigen (HBsAg), achieving HBsAg clearance, and lowering hepatitis B virus DNA levels, drawing attention from experts both in and outside China. To date, no drug has demonstrated such significant therapeutic activity in clinical trials. Breakthrough TherapyThe recognition will furtherAccelerate the clinical development process of this drug to meet the unmet treatment needs in the field of chronic hepatitis B both in China and internationally as soon as possible.

Dr. Dongxu Shu, founder and CEO of Argo Biopharma, said: “BW-20507Receiving the Breakthrough Therapy Designation marks the company's progress in developing highly differentiatedsiRNATherapy Addresses Unmet Medical Needs Across Multiple Treatment AreasA Key Step Forward on the Road to SeekingStep. ForHBVThe challenge of a low functional cure rate,siRNAThe therapy has unique advantages.BW-20507The breakthrough once again validates the company RADSTM The platform's efficient drug discovery capabilities. We will work closely with regulatory agencies and clinical researchers to accelerate the advancement of subsequent clinical trials."