Revolutionary ASC22 Subcutaneous PD-L1 Antibody Achieves Functional Cure of Chronic Hepatitis B: Presentation at APASL 2023

Ascletis Pharma Inc. (HKEX:1672) is proud to announce that their subcutaneous PD-L1 antibody, ASC22 (Envafolimab), has been found to potentially provide a functional cure for chronic hepatitis B (CHB). This finding was presented at the 2023 Annual Meeting of the Asian Pacific Association for the Study of the Liver (APASL Annual Meeting 2023). This could represent a major breakthrough in the treatment of CHB and provide hope for those living with the condition.

At the APASL Annual Meeting 2023, the results of the 1.0 mg/kg ASC22 (administered subcutaneously once every two weeks) vs placebo cohort ( NCT04465890) were presented. After 24-weeks of treatment, the remarkable HBsAg decline of ASC22 was revealed. In the patient sub-group with baseline HBsAg ≤100 IU/mL, an impressive 42.9% (3/7) achieved HBsAg loss (below the lower limit of quantification, LLOQ < 0.05 IU/mL) during treatment and the CHB functional cure was maintained up to the completion of 24-week or 41-week follow-up. This CHB functional cure is defined as achieving HBsAg loss with a finite treatment duration (24-48 weeks) and a HBsAg loss that still persists after 24-week follow-up.

The data revealed a significant correlation between pre-treatment HBsAg levels and HBsAg reduction after ASC22 treatment: patients with baseline HBsAg levels ≤100 IU/mL showed a statistically significant reduction in HBsAg at the end of both the 24-week treatment and the 24-week follow-up (P < 0.001). This was in contrast to the patient sub-groups with baseline HBsAg of 101-1000 IU/mL (n=18) and >1000 IU/mL (n=23) which showed no such significant reduction. Interestingly, prior interferon treatment and length of prior Nucleot(s)ide analogues (NAs) treatment had no impact on the HBsAg reduction.

The results of the CHB patient study of ASC22 were very encouraging; the drug was found to be safe and well-tolerated. Out of all the adverse events reported, 97.5% were mild, and there were no serious side effects reported in the 1.0 mg/kg ASC22 cohort. This bodes well for the further development of ASC22 as a potential treatment for CHB.

Studies in China and the U.S. have found that 15-22% of total chronic hepatitis B (CHB) patients have HBsAg levels of ≤100 IU/mL—a significant proportion of the overall CHB population.

Today, Professor Guiqiang Wang, Director of the Infectious Diseases Department and Liver Disease Center of Peking University First Hospital, revealed the conclusive results of the 1.0 mg/kg ASC22 vs placebo cohort at the APASL Annual Meeting 2023. His findings have the potential to revolutionize the treatment of infectious diseases and liver diseases alike.

About Ascletis

Ascletis is an innovative biotech company listed on the Hong Kong Stock Exchange (1672.HK), that is dedicated to discovering, developing, manufacturing and commercializing treatments for unmet medical needs. Led by a highly experienced management team, Ascletis has an impressive pipeline of 23 drug candidates, the most advanced of which include ASC22 (HBV functional cure), ASC10 and ASC11 (oral small molecules for COVID-19 treatment), ASC40 (recurrent glioblastoma), ASC42 (PBC, primary biliary cholangitis), and ASC40 (acne). In addition, Ascletis has three marketed products – ritonavir tablets, GANOVO® and ASCLEVIR® – that are already helping to improve the lives of patients around the world. With a clear vision and an unwavering commitment to excellence, Ascletis is set to become a leader in the global biotech industry.

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