Core Insights - China Biopharmaceutical (01177) announced that its self-developed national class 1 innovative drug TQA3605, a core protein allosteric modulator (CpAM), has recently completed a phase II clinical trial for patients with chronic hepatitis B virus (HBV) infection, achieving its primary endpoint [1] Group 1: Clinical Trial Results - The study was a randomized, double-blind, placebo-controlled, multi-center phase II trial (NCT06644417) aimed at evaluating the efficacy and safety of TQA3605 in combination with nucleos(t)ide analogs (NAs) in treated patients with low viral load [1] - A total of 122 subjects were enrolled, divided into a placebo control group and multiple different dosage groups of TQA3605, administered orally once daily [1] - Results showed that among adult HBV-infected patients who had received NAs treatment for at least 12 months, TQA3605 combined with NAs for 24 weeks significantly increased the proportion of subjects with HBV DNA below the lower limit of quantification (<20 IU/mL), with nearly 90% in all dosage groups, significantly better than the NAs monotherapy control group (p < 0.0001) [1] - In terms of safety, TQA3605 demonstrated overall good safety, with the incidence of adverse reactions comparable to the control group, and most treatment-emergent adverse events (TEAEs) were of grade 1-2, with no new safety signals observed [1] Group 2: Drug Profile and Market Potential - TQA3605 is a core protein modulator developed by the company that can effectively inhibit multiple genotypes of HBV and has no cross-resistance with NAs [2] - Currently, there are no approved core protein modulators for HBV globally, and compared to other similar investigational drugs, TQA3605 shows superior safety and a more convenient once-daily oral administration, potentially providing a new treatment option for chronic HBV-infected patients [2]

Core Insights - China Biologic Products (01177.HK) announced the completion of Phase II clinical trials for its self-developed innovative drug TQA3605, a core protein allosteric modulator (CpAM), targeting chronic hepatitis B virus (HBV) infection patients, achieving its primary endpoint [1] Group 1: Clinical Trial Details - The study was a randomized, double-blind, placebo-controlled, multi-center Phase II trial (NCT06644417) aimed at evaluating the efficacy and safety of TQA3605 in combination with nucleos(t)ide analogs (NAs) in chronic HBV patients with low viral load [1] - A total of 122 subjects were enrolled, divided into a placebo group and multiple dosage groups of TQA3605, administered orally once daily [1] Group 2: Efficacy Results - Results indicated that among adult HBV patients who had received NAs treatment for at least 12 months, the combination therapy of TQA3605 and NAs for 24 weeks significantly increased the proportion of subjects with HBV DNA below the lower limit of quantification (<20 IU/mL), with nearly 90% in all dosage groups, significantly outperforming the NAs monotherapy control group (p < 0.0001) [1] Group 3: Safety Profile - The overall safety profile of TQA3605 was found to be good, with the incidence of adverse reactions comparable to the control group, and most treatment-emergent adverse events (TEAEs) were of grade 1-2, with no new safety signals observed [1] - Detailed study results are expected to be presented at upcoming international academic conferences [1]