Recently, Chia Tai Tianqing, a core enterprise of Sino Biopharm (1177.HK), announced that its oral Class 1 innovative drug for chronic hepatitis B virus (HBV) infection, the core protein allosteric modulator TQA3605, has met the primary study endpoint in its Phase II clinical study. After 24 weeks of treatment with TQA3605 in combination with nucleos(t)ide analogues (NAs) across all dose groups, nearly 90% of subjects had HBV DNA levels below the lower limit of quantification (20 IU/mL), demonstrating its ability to further suppress viral replication in the low viraemia population. 

Chronic hepatitis B has long been one of China's major public health challenges. Without timely, effective, and standardized treatment, there is a risk of progression to end-stage liver diseases such as hepatic cirrhosis and hepatocellular carcinoma. Data released by the Polaris Observatory Collaborators show that in 2022, there were 79.74 million people infected with the hepatitis B virus (HBV) in China, including about 23 million patients with chronic hepatitis B. However, with a diagnosis rate of only 22% and a treatment rate of only 15%, over 80% of patients face the risk of disease progression, indicating a significant gap between clinical treatment needs and available methods. 

Existing clinical antiviral drugs such as nucleos(t)ide analogues (NAs) can effectively suppress HBV replication, but some patients still experience poor response and low viraemia, the dangers of which should not be overlooked. In patients with low viraemia, even if the viral load is very low, the virus continues to replicate within liver cells, causing persistent hepatocyte necrosis and inflammation. This also significantly increases the risk of drug resistance and accelerates the progression of hepatic fibrosis/hepatic cirrhosis, much like a "slow simmer". Furthermore, patients with low viraemia have a higher risk of disease progression, with the incidence of hepatocellular carcinoma being 2-4 times higher, or even more, than in those with complete viral suppression. 

As novel anti-HBV drugs, Core protein Allosteric Modulators (CpAMs) target the hepatitis B core antigen (HBcAg) to block the formation of the viral nucleocapsid, thereby inhibiting viral replication. They can also indirectly affect the stability of the covalently closed circular DNA (cccDNA) pool and have a relatively high resistance barrier. TQA3605 tablets are a hepatitis B core protein allosteric modulator independently developed by Chia Tai Tianqing. It is a Class 1 investigational innovative anti-HBV drug with a novel mechanism that can effectively inhibit the replication of multiple HBV genotypes and has no cross-resistance with standard-of-care NAs. 

A randomized, double-blind, placebo-controlled, multi-center Phase II study (NCT06644417), led by Professor Xie Qing from Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, aims to evaluate the efficacy and safety of TQA3605 combined with NAs in treatment-experienced subjects with chronic HBV infection and low viraemia. The study ultimately enrolled 122 subjects with chronic HBV infection who had been treated with NAs for at least 12 months. While maintaining their prior NA therapy, they were randomly assigned to receive either an add-on placebo or TQA3605, administered orally once daily. 

The results showed that 24 weeks of treatment with TQA3605 combined with NAs significantly increased the percentage of subjects with HBV DNA below the lower limit of quantification (<20 IU/mL), with all dose groups approaching 90%, which was superior to the NA monotherapy control group (p < 0.0001). In terms of safety, the overall incidence of adverse reactions in the test group with add-on TQA3605 was comparable to the NA monotherapy control group, and most treatment-emergent adverse events (TEAEs) were Grade 1-2. The detailed results of this study will be presented at upcoming international academic conferences. 

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