SBP GROUP (01177.HK): Two Hepatitis B Drugs Granted CDE Breakthrough Therapy Status

NewTimeSpace News: On 27 October 2026, Sino Biopharmaceutical Limited (stock code: 1177) announced that TQ-A3334 (a Toll-like receptor 7 agonist) and TQA3605 (a core protein allosteric modulator), two Class 1 innovative drugs independently developed by its subsidiary Chia Tai Tianqing, have both been granted breakthrough therapy designation by the Centre for Drug Evaluation of China's National Medical Products Administration, addressing unmet needs in functional cure and low-level viraemia (LLV) in chronic hepatitis B.

TQ-A3334 is an oral highly selective TLR7 agonist that activates innate and adaptive immune pathways, induces interferon and cytokine responses and remodels the body's anti-HBV immune response, complementing the direct antiviral action of nucleos(t)ide analogues (NAs). The designation was based mainly on Phase II data showing potential for substantive improvement in key efficacy endpoints; the results were selected as a late-breaking abstract at the 2026 AASLD meeting and will be presented orally.

TQA3605 is an oral core protein allosteric modulator that inhibits replication of multiple HBV genotypes without cross-resistance to NAs. Its Phase II study showed that 24 weeks of combination treatment with NAs significantly increased the proportion of subjects with HBV DNA below 20 IU/mL, with response rates approaching 90% in all treatment arms versus the NA monotherapy control (p<0.0001). TQA3605 has entered Phase III, while TQ-A3334 will soon enter Phase III.

The announcement cited about 290 million chronic HBV infections globally, including about 75 million in China; without timely standard treatment, chronic hepatitis B can progress to cirrhosis, liver failure and hepatocellular carcinoma.