Bowave Pharmaceuticals Receives NMPA Approval for Phase II Clinical Trial of siRNA-Based Combination Therapy for Chronic Hepatitis B in China

On July 1, Argo Biopharma announced its self-developed Class 1 new drugBW-20507 in combination with pegylated interferon alpha (PEG-IFNα, referred to as "interferon")Granted Phase II Clinical Trial Approval by the China National Medical Products Administration (NMPA) for the treatment of Chronic Hepatitis B (CHB).

The press release stated that this milestone combination therapy builds on the significant progress achieved with BW-20507, including the Breakthrough Therapy Designation (BTD) for monotherapy granted by the NMPA in June 2025, as well as the Phase I/IIa clinical data presented in the Late-Breaker session at the European Association for the Study of the Liver (EASL) annual meeting in May 2025, which demonstrated "best-in-class" therapeutic potential. This combination therapy works through a dual mechanism synergy:

• BW-20507, as an siRNA drug that precisely targets HBV S-region mRNA, can strongly inhibit viral gene expression, achieving a rapid and sustained reduction in hepatitis B surface antigen (HBsAg);

• Pegylated interferon α enhances the innate and adaptive immune clearance of HBV-infected hepatocytes through immunomodulatory effects.

Latest data indicates that patients with lower HBsAg levels are more sensitive to interferon therapy. Pre-treatment reduction of HBsAg load via the RNA interference mechanism of BW-20507 is expected to enhance interferon treatment response rates, shorten the duration of interferon therapy, and improve tolerability. Preclinical and early clinical data have already shown that this combination therapy can significantly increase HBsAg clearance rates.

"This IND approval is an important step towards our goal of significantly improving the functional cure rate for CHB," said Dr. Dongxu Shu, co-founder and CEO of Argo Biopharma. "By combining the potent HBsAg-lowering properties of siRNA drugs with the immune-stimulating effects of PEG-IFNα, we aim to overcome the limitations of existing therapies and achieve sustained HBsAg clearance. This clinical trial authorization allows us to clinically validate this synergistic therapy, which has the potential to reshape the treatment landscape for CHB."

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 an important breakthrough in the field of functional cure.

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 disorders, viral infections, central nervous system diseases, and rare diseases. Currently, Argo Biopharma has six RNAi candidate drugs in clinical studies.