China-based Hengrui Pharma has secured breakthrough therapy designation (BTD) from China's Centre for Drug Evaluation (CDE) for its liver-targeting siRNA therapeutic HRS-5635 for chronic hepatitis B (CHB) treatment. The investigational RNA interference agent demonstrates potent antiviral activity against all HBV genotypes with sustained viral suppression in pre-clinical studies and favourable safety profiles without off-target effects. HRS-5635 represents a novel approach to achieving functional cure through hepatitis B surface antigen clearance, addressing unmet needs for China's estimated 75 million HBV carriers where only 300,000 currently receive antiviral therapy.

CHB affects approximately 257 million people globally with 887,000 annual deaths from related complications including cirrhosis and hepatocellular carcinoma (HCC). Current nucleos(t)ide analogues and interferon therapies achieve functional cure in less than 10% of patients after prolonged treatment. HRS-5635 is currently in Phase II trials with potential to improve upon first-generation siRNA candidates through enhanced liver targeting and durability of response.

According to PharmCube's NextBiopharm® database, there currently exist 14 active projects developing siRNA candidates for CHB, conducted by a total 18 companies (mostly Chinese). Click here to request a free trial for NextBiopharm®.