Zhitong Finance App News, China Biopharmaceutical (01177) announced that the national Class 1 innovative drugs TQ-A3334 “Toll-like Receptor 7 (TLR7) Agonist” and TQA3605 “Core Protein Allogenesis Modulator” independently developed by Zhengda Tianqing Pharmaceutical Group Co., Ltd. (Zhengda Tianqing), a subsidiary of the Group, have all been included in the breakthrough therapeutic drug program by the China Drug Administration Drug Evaluation Center (CDE). The two innovative drugs address the two major unmet needs in the treatment of chronic hepatitis B (chronic hepatitis B): functional cure and hypoviremia (LLV).
TQ-A3334 is an oral highly selective TLR7 agonist independently developed by Chia Tai Tianqing. It induces interferon and cytokine responses by activating intrinsic immunity and adaptive immune pathways, thereby remodeling the body's immune response against hepatitis B virus (HBV), complementing the direct antiviral effects of nucleoside (acid) analogs (NAs), and is an important exploration in the direction of functional treatment of hepatitis B.
This time, the drug was included in the breakthrough treatment program, mainly based on its phase II clinical data showing substantial improvement potential in key efficacy indicators; the relevant research results were also selected for the 2026 American Society for Liver Disease Research (AASLD) Latest Breakthrough Summary (LBA) and will be published in the form of an oral report.
TQA3605 is a core protein allosteric modulator (cPAM) independently developed by Zhengda Tianqing. It can effectively inhibit HBV replication in various genotypes, and has no cross-resistance with standard therapeutic drugs, NAs. TQA3605 blocks viral nuclear capsid formation by targeting the hepatitis B core antigen (HBcAg), thereby inhibiting viral replication, and can also indirectly affect the stability of covalent closed circular DNA (cccDNA) banks, and has a relatively high drug resistance barrier. This time, TQA3605 was included in the breakthrough therapeutic drug program, mainly based on the positive results of its phase II clinical study: 24 weeks of treatment with TQA3605 combined with NAS can significantly increase the proportion of subjects with HbV DNA below the lower limit of quantitative detection (<20 IU/ml). The response rate of all treatment groups was close to 90%, which was superior to the NAS single drug control group (p<0.0001). The above results suggest that TQA3605 is expected to provide a new treatment option for the clinical challenge of LLV.
Chronic hepatitis B is a major global public health problem. There are about 290 million people with chronic HBV infections worldwide, of which there are about 75 million in China. Without timely and standardized treatment, chronic hepatitis B can further progress to cirrhosis, liver failure, and hepatocellular carcinoma. Although standard antiviral treatments represented by NAs have been widely used and are effective in improving patient outcomes, clinical management of chronic hepatitis B still faces two major unmet needs:
High functional healing barriers: Although NAS can strongly inhibit HbV replication, the inhibitory effect on hepatitis B surface antigen (HBsAg) is limited; although long-acting interferon (PEG-IFNα) can improve HBsAg clearance in some patients, there are large individual differences and limited tolerability. Achieving both negative HBsAg and HbV DNA within a limited course of treatment (i.e. functional cure) is still globally recognized as an ideal treatment goal.
The risk of LLV is underestimated: even after receiving standard NAs treatment, some patients continue to have a low viral load. The virus is not completely removed and continues to replicate within hepatocytes, which can accelerate the progression of liver fibrosis and cirrhosis; the risk of hepatocellular carcinoma (HCC) is about 2 to 4 times that of those who have achieved complete suppression of the virus.
Currently, these two new drugs under development with highly differentiated advantages are steadily advancing clinical development: TQA3605 has started phase III clinical trials, and TQ-A3334 is about to enter phase III clinical trials. The Group will continue to advance the clinical development of two drug candidates with a view to bringing new treatment options to patients with chronic hepatitis B as soon as possible.