Bowave Pharmaceuticals Achieves Milestone with First Patient Dosed in Phase II Trial of Novel siRNA Therapy BW-20507 for Chronic Hepatitis B

　　【Pharmaceutical Network Industry DynamicsOn September 8, 2025, Argo Biopharma announced exciting news: the first patient dosing was completed in the Phase II clinical trial of BW-20507, a novel drug independently developed by the company for the treatment of chronic hepatitis B (CHB). This milestone marks another significant step forward in China's development of innovative hepatitis B drugs.
 

It is reported that in June 2025, the therapy received Phase II clinical trial approval from the National Medical Products Administration. This Phase II clinical trial will evaluate the efficacy of BW-20507 as a monotherapy and in combination with long-acting interferon.
 

Chronic hepatitis B is a serious public health issue in China and globally. The prevalence of hepatitis B surface antigen (HBsAg) in the general population in China reaches 5.86%, with approximately 75 million people living with hepatitis B. Long-term infection with the hepatitis B virus can lead to severe complications such as liver cirrhosis and liver cancer, imposing a heavy burden on patients' health and socio-economic conditions. Traditional treatment methods struggle to achieve functional cure, making the development of novel and effective hepatitis B treatments urgently needed.
 

BW-20507, as an siRNA drug targeting the HBV S-region mRNA, can potently 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 its immunomodulatory effects. New data indicate that patients with lower HBsAg levels are more sensitive to interferon treatment. Pre-treatment with BW-20507's RNA interference mechanism to reduce HBsAg load has the potential to improve interferon treatment response rates, shorten the course of interferon therapy, and enhance tolerability. The initiation of this Phase II clinical trial is a crucial step in further validating its safety and efficacy. If successful, the trial will offer a new therapeutic option for patients with hepatitis B and could potentially transform the treatment landscape for the disease.
 

Notably, in China, the field of innovative drug development for hepatitis B is thriving with diverse progress. Currently, multiple new drugs for the treatment of chronic hepatitis B have been designated as breakthrough therapies. Among them, ZM-H1505R (Canocapavir), developed by Shanghai Zhimeng Biopharma Inc., is a potent HBV capsid inhibitor. Unlike traditional HBV capsid inhibitors, which belong to heteroaryldihydropyrimidines (HAPs) and phenylpropenamides (PPAs), this drug features a novel chemical scaffold and is a pyrazole-based capsid inhibitor. Recently, the company announced that the first patient has been dosed in the Phase III clinical trial of this drug.
 

Fujian Cosunter Pharmaceutical Co., Ltd.'s chronic hepatitis B virus drug GST-HG141 has entered Phase III clinical trials, with the first subject successfully enrolled and dosed on July 25. In December 2024, it was included in the list of breakthrough therapies by the Center for Drug Evaluation of the National Medical Products Administration.
 

In addition, the new drugs under research for the treatment of chronic hepatitis B included in the breakthrough therapy in China also include Bepirovirsen (GSK3228836, GSK836) Injection (antisense oligonucleotide), AHB-137 Injection (antisense oligonucleotide), BRII-835 (VIR-2218) Injection (RNAi therapeutic), BRII-179 (VBI-2601) Injection (therapeutic hepatitis B vaccine), BRII-877 (VIR-3434) for injection (neutralizing antibody), and BW-20507 (RNAi therapeutic), etc. Among them, the antisense oligonucleotide Bepirovirsen (GSK3228836, GSK836) Injection is expected to be launched in 2026.
 

The emergence of these new drugs under research highlights China's strength and determination in the field of innovative hepatitis B drug development. With the deepening of research and the advancement of clinical trials, it is believed that in the near future, more safe and effective innovative hepatitis B drugs will be launched, bringing hope to the vast number of hepatitis B patients for getting rid of the disease troubles, and assisting China and even the global hepatitis B prevention and treatment cause to achieve significant breakthroughs. Data show that Argo Biopharma, mentioned above, is a biotechnology company in the clinical research stage, committed to developing a new generation of RNAi therapies. The company relies on liver-targeted and extrahepatic delivery technology platforms to build a diversified RNAi drug research and development pipeline covering cardiometabolic, special diseases, viral infections, central nervous system diseases, and rare diseases. Currently, Argo Biopharma has six RNAi candidate drugs entering clinical research.
 

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