SBP GROUP (01177): TQ-A3334 "TLR7 agonist" and TQA3605 "core protein allosteric modulator" granted Breakthrough Therapy Designation by CDE

SBP GROUP (01177) announced that TQ-A3334, a Class 1 innovative drug "Toll-like receptor 7 (TLR7) agonist" and TQA3605, a "core protein allosteric modulator", both independently developed by the company's subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Chia Tai Tianqing), have been granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration. The two innovative drugs each address two major unmet needs in the treatment of chronic hepatitis B (CHB): functional cure and low-level viremia (LLV). TQ-A3334 is an orally administered, highly selective TLR7 agonist independently developed by Chia Tai Tianqing. By activating innate and adaptive immune pathways, it induces interferon and cytokine responses, thereby remodeling the body's immune response against hepatitis B virus (HBV) and complementing the direct antiviral effect of nucleos(t)ide analogues (NAs). It is an important exploration in the direction of functional cure for hepatitis B. The drug's inclusion in the Breakthrough Therapy Designation program was primarily based on the substantial improvement potential demonstrated by its Phase II clinical data in key efficacy endpoints; the relevant study results were also selected as a Late-Breaking Abstract (LBA) for the 2026 American Association for the Study of Liver Diseases (AASLD) and will be presented in an oral presentation. TQA3605 is a core protein allosteric modulator (CpAM) independently developed by Chia Tai Tianqing. It can effectively inhibit HBV replication across multiple genotypes and has no cross-resistance with the standard-of-care drug NAs. By targeting hepatitis B core antigen (HBcAg), TQA3605 blocks viral nucleocapsid formation, thereby inhibiting viral replication, and can indirectly affect the stability of the covalently closed circular DNA (cccDNA) pool, with a relatively high resistance barrier. TQA3605's inclusion in the Breakthrough Therapy Designation program was primarily based on positive results from its Phase II clinical study: 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 response rates approaching 90% across all treatment groups, superior to the NAs monotherapy control group (p<0.0001). These results suggest that TQA3605 is expected to provide a new treatment option for the clinical challenge of LLV. CHB is a major global public health issue. There are approximately 290 million chronic HBV carriers worldwide, of whom approximately 75 million are in China. Without timely and standardized treatment, CHB can further progress to cirrhosis, liver failure, and hepatocellular carcinoma. Although standard antiviral therapy represented by NAs has been widely used and has effectively improved patient prognosis, current clinical management of CHB still faces two major unmet needs: High barrier to functional cure: Although NAs can potently inhibit HBV replication, their inhibitory effect on hepatitis B surface antigen (HBsAg) is limited; pegylated interferon (peg-IFN), while able to increase HBsAg clearance rates in some patients, shows substantial individual variability and limited tolerability. Achieving dual negativity for both HBsAg and HBV DNA (i.e., functional cure) within a limited treatment course remains a globally recognized ideal treatment goal. Underestimated LLV risk: Even with standardized NA treatment, some patients remain in a persistent low viral load state, with the virus not fully cleared and continuing to replicate in hepatocytes, which can accelerate the progression of liver fibrosis and cirrhosis; their risk of developing hepatocellular carcinoma (HCC) is approximately 2 to 4 times that of those who achieve complete viral suppression. Currently, these two highly differentiated investigational new drugs are steadily advancing in clinical development: TQA3605 has initiated 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 both candidate drugs, with the aim of bringing new treatment options to CHB patients as soon as possible.