Logo

Ascletis’s ASC22 (envafolimab) Receives US FDA’s IND Approval of ASC22 (envafolimab) for the Treatment of Chronic Hepatitis B

Share this

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

Click here to­ read the full press release 

Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions