Ascletis Pharma Inc. (Ascletis) and Suzhou Alphamab Co., Ltd. (Suzhou Alphamab) jointly announced that Ascletis’ subsidiary and Suzhou Alphamab have entered into an exclusive worldwide licensing agreement (excluding Greater China) for ASC22 (Envafolimab) to treat viral diseases, including Hepatitis B. According to the press release, ASC22, also known as KN035, is one of the first subcutaneously-injected PD-L1 antibodies. An oncology biologic license application was submitted to the Chinese National Medicine Products Administration in December 2020, and other oncology indications are currently under development by Jiangsu Alphamab Biopharmaceuticals Co., Ltd.
Under the terms of the agreement, Ascletis will receive from Suzhou Alphamab all rights to develop and commercialize ASC22. Ascletis will pay Suzhou Alphamab an upfront payment in cash, and Suzhou Alphamab is eligible to receive milestone payments from Ascletis based on development, regulatory, and commercial targets in addition to tiered royalties (ranging from approximately fifteen to twenty percent) on the future sales of ASC22. Suzhou Alphamab will manufacture ASC22 for clinical trials and commercialize the product.