SBP GROUP(01177): BEPIROVIRSEN to be announced Phase III clinical data at EASL 2026.

06:23 29/05/2026

China Biologic Products (01177) has announced that its subsidiary, Chino Biologics Group Co., Ltd. (Chino Biologics), in collaboration with GlaxoSmithKline (GSK), has released positive key data on bepirovirsen for the treatment of chronic hepatitis B (CHB).

SBP GROUP (01177) announced that its subsidiary, Zhongda Tianqing Pharmaceutical Group Co., Ltd. (Zhongda Tianqing), in cooperation with GlaxoSmithKline (GSK), has released key positive data on bepirovirsen for the treatment of chronic hepatitis B (CHB). The results of the two Phase III clinical trials, B-Well 1 (NCT05630807) and B-Well 2 (NCT05630820), have been published in the New England Journal of Medicine and will be presented at the 2026 European Association for the Study of Liver Disease (EASL) conference. Regional subgroup data were also presented at the EASL meeting. The Chinese subgroup data showed that in subjects with HBsAg 3000 IU/ml, the functional cure rate was 24%; in subjects with HBsAg 1000 IU/ml, the functional cure rate reached 35%. The combined data from the two trials showed a statistically and clinically significant functional cure rate of 19% in the overall study population (adults with hepatitis B surface antigen (HBsAg) levels 3000 IU/ml) at 6 months of bepirovirsen treatment (233/1220 vs. 0/614 in the placebo group, p<0.001). A key secondary endpoint showed a functional cure rate of 26% in subjects with HBsAg 1000 IU/ml (200/768 vs. 0/393 in the placebo group, p<0.001), representing approximately 45% of the global chronic hepatitis B diagnosed cases. The current standard of care typically requires lifelong medication, with a functional cure rate of less than 1%. Functional cure requires the continuous undetectable presence of hepatitis B virus DNA and HBsAg in the blood for at least 6 months after stopping all treatment. This indicates that the immune system is able to control the infection without the need for medication. The reduction of HBsAg is also associated with a reduced risk of liver cancer by 89% and all-cause mortality by 62%. In an exploratory analysis, 49% of bepirovirsen subjects achieved a quantitative surface antigen level (qHBsAg) of 100 IU/ml one year after the end of treatment, which is considered to be related to enhanced immune control and improved patient prognosis. Additionally, a key secondary endpoint showed that 23% of all subjects (283/1220 vs. 0/614 in the placebo group; p<0.001) and 31% of subjects with a baseline HBsAg 1000 IU/ml (237/768 vs. 0/393 in the placebo group; p<0.001) achieved sustained hepatitis B virus DNA levels below the quantification limit (

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