Bowang Pharmaceuticals Completes First-in-Human Dosing in China Phase I Clinical Trial of BW-03 for Chronic Hepatitis B

HBV infection is one of the most severe infectious disease threats worldwide, with over 254 million people currently infected globally. Chronic hepatitis B is a leading cause of liver disease, resulting in approximately 820,000 deaths annually due to complications from chronic hepatitis B. China has a high incidence of chronic hepatitis B, with about 87 million infected individuals, and there is still a lack of effective drugs to cure chronic hepatitis B.

BW-03 has previously conducted a global Phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses in healthy subjects, as well as the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses in patients with chronic hepatitis B. In December 2023, all healthy subjects in Australia completed the clinical trial, and in May 2024, all patients with chronic hepatitis B in Thailand and Hong Kong were enrolled. In the same month, ethical committee approval was obtained to initiate the Phase I clinical trial in mainland China.

Argo Biopharma, established in 2021, is a clinical-stage biotechnology company dedicated to developing a new generation of siRNA drugs to provide better treatment options for patients worldwide. Over the past three years, Argo Biopharma has built a rich and differentiated pipeline of siRNA drug candidates covering a wide range of indications, including cardiovascular diseases, rare diseases, central nervous system (CNS) disorders, viral infections, and metabolic diseases. Currently, five of its siRNA drugs have entered clinical trials. Notably, in January 2024, Argo Biopharma reached licensing and strategic collaboration agreements with Novartis for multiple RNAi projects. Under the agreements, Argo Biopharma will receive an upfront payment of $185 million from Novartis, as well as milestone payments and tiered royalties on commercial sales with a total potential transaction value of nearly $4.2 billion.