Ascletis’s ASC22 (envafolimab) Receives US FDA’s IND Approval of ASC22 (envafolimab) for the Treatment of Chronic Hepatitis B
Shots:
- The US FDA has approved an IND application to initiate the global development of ASC22 while the P-IIb study evaluates the efficacy and safety of ASC22 (1/2.5mg/kg) vs PBO in combination with NAs in 149 patients with CHB
- Additionally, interim results from the P-IIb trial showed that ~19% (3/16) of patients in the treatment group obtained HBsAg loss in patients with the baseline HBsAg level ≤ 500 IU/mL compared to PBO where no patient achieved HBsAg loss & no rebound after the last dosing of ASC22
- Ascletis had obtained an exclusive license globally from Suzhou Alphamab to develop and commercialize ASC22 for all viral diseases including Hepatitis B
Ref: PR Newswire | Image: Crunchbase
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