Sino Biopharmaceutical Limited (1177) recently reported that its independently developed Class I innovative drug, TQA3605 tablets—known as a Core Protein Allosteric Modulator (CpAM)—has successfully completed a Phase II clinical trial for chronic hepatitis B virus (HBV) infection, meeting its primary endpoint.
The multicenter, randomized, double-blind, placebo-controlled study enrolled 122 participants who had received nucleos(t)ide analogues (NAs) for at least 12 months. Combining TQA3605 with NAs for 24 weeks significantly enhanced the percentage of patients achieving HBV DNA levels below the lower limit of quantification (less than 20 IU/mL), reaching around 90% in all TQA3605 dose groups. These results notably surpassed the control group on monotherapy (p<0.0001).
TQA3605 also demonstrated a generally favorable safety profile. No new safety signals emerged, and most treatment-emergent adverse events were classified as Grade 1 to 2. Further details are to be shared at upcoming international academic conferences.
There are approximately 86 million HBV carriers in the People’s Republic of China, of which around 30 million are chronic HBV-infected patients. Long-term medication is often required for HBV, highlighting the need for novel therapeutic approaches. TQA3605, which can effectively suppress multiple HBV genotypes with no cross-resistance to NAs, is administered once daily and offers a potentially convenient treatment option for chronic HBV infection.
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