Chinese biotechnology company, Ascletis Pharma Inc. has entered into a worldwide license agreement with Suzhou Alphamab Co., Ltd., outside Greater China for ASC22 (Envafolimab) for the treatment of all viral diseases inclusive of Hepatitis B.

Also called KN035, ASC22 is a subcutaneously injected, first-in-class PD-L1 antibody. While Jiangsu Alphamab Biopharmaceuticals Co., Ltd., is working on the development of oncology indications, an oncology BLA (biologic license application) of KN035 was submitted to China NMPA (National Medicine Products Administration) in the month of December 2020.

According to Ascletis’ Chairman and CEO, Jinzi J. Wu, the company is excited to collaborate with Suzhou Alphamab, a major biopharmaceutical firm, on a global basis. Ascletis is a global leader in the field of antiviral drug development such as Hepatitis B which continues to be a highly unmet medical requirement at the global level.

Via strategic partnership with Alphamab, the company is advancing the global development of ASC22 as a first-in-class HBV immunotherapy. This has been possible due to the advantage in convenience and safety and the encouraging Phase IIa and Phase IIb efficacy data.

Through this collaboration, the company hopes to provide a functional cure for Hepatitis B patients soon, added Wu.

Under this agreement, Ascletis secured a worldwide and exclusive license outside Greater China for the development and commercialization of ASC22 for all viral diseases inclusive of Hepatitis B.

Furthermore, the company will be making a cash upfront payment to Suzhou Alphamab and the latter will be eligible to obtain payments from Ascletis on commercial, regulatory, and development milestones.

This also includes tiered royalties from the mid-teens to nearly twenty percent on future sales of ASC22. In addition, Suzhou Alphamab will be manufacturing ASC22 for the commercialization of viral indications and clinical trials for Ascletis.

For the record, ASC22 constitutes the most advanced clinical stage immunotherapy at the global level for CHB (chronic hepatitis B) functional cure, that is also called HBsAg (hepatitis B surface antigen) loss, via blocking PD-1/PD-L1 pathway.

Source credit: https://www.prnewswire.com/news-releases/ascletis-and-suzhou-alphamab-expand-their-partnership-into-worldwide-license-agreement-for-asc22-envafolimab-to-treat-hepatitis-b-and-other-viral-diseases-301418129.html