Ascletis Pharma Inc. (1672.HK) and Suzhou Alphamab Co., Ltd. (Suzhou Alphamab) jointly announce today that Ascletis' subsidiary and Suzhou Alphamab have entered into an exclusive and worldwide license agreement outside Greater China for ASC22 (Envafolimab) to treat all viral diseases including Hepatitis B. ASC22, also known as KN035, is a first-in-class subcutaneously injected PD-L1 antibody. Oncology indications are under development by Jiangsu Alphamab Biopharmaceuticals Co., Ltd. and an oncology biologic license application ("BLA") of KN035 was submitted to China National Medicine Products Administration (NMPA) in December 2020. Under the terms of this agreement, Ascletis obtained an exclusive and worldwide license outside Greater China from Suzhou Alphamab to develop and commercialize ASC22 for all viral diseases including Hepatitis B. Ascletis will pay Suzhou Alphamab a cash upfront payment and Suzhou Alphamab will be eligible to receive payments from Ascletis on development, regulatory and commercial milestones as well as tiered royalties from the mid-teens to around twenty percent on future sales of ASC22. Suzhou Alphamab will manufacture ASC22 for clinical trials and commercialization of viral indications for Ascletis. Together with the exclusive license agreement in Greater China announced jointly by Ascletis and Suzhou Alphamab on January 14, 2019 (Details referring to press release: https://www.ascletis.com/news_detail/171/id/290.html), Ascletis has now obtained a global and exclusive license from Suzhou Alphamab to develop and commercialize ASC22 for all viral diseases including Hepatitis B. Ascletis books sales globally for ASC22 of all viral diseases. ASC22 is the most advanced clinical stage immunotherapy in the world for chronic hepatitis B (CHB) functional cure, i.e. hepatitis B surface antigen (HBsAg) loss, through blocking PD-1/PD-L1 pathway. A Phase IIa clinical trial of ASC22 in CHB patients was completed and the data indicated that there was a trend of dose dependent HBsAg reduction after single dose administration of 0.3, 1.0 or 2.5 mg/kg ASC22. Among three patients receiving 2.5 mg/kg dose, one patient achieved a maximum HBsAg reduction of 1.2 log10 IU/mL during the 12-week follow up. The Phase IIa results will be presented in oral parallel session at The Liver Meeting
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