15 January 2019 - - A subsidiary of Chinese biotechnology company Ascletis Pharma Inc. and Suzhou Alphamab Co., Ltd. have entered into a strategic collaboration and exclusive licensing agreement for anti-PD-L1 KN035 to treat hepatitis B and other viral diseases in Greater China (Ascletis code: ASC22), the companies said.

KN035 is an investigational programmed cell death ligand-1 (PD-L1) monoclonal antibody which has been exposed to more than 500 patients in multiple clinical trials in US, China and Japan.

Under the terms of the agreement, Ascletis has an exclusive license from Alphamab to develop and commercialise ASC22 (KN035) for viral diseases including hepatitis B in Greater China.

Ascletis will pay Alphamab a cash upfront payment and Alphamab will be eligible to receive payments in development and commercial milestones as well as tiered royalties from the mid-teens to around 20% on future sales of ASC22 (KN035).

Alphamab will manufacture ASC22 (KN035) for clinical trials and commercialization of viral indications in Greater China for Ascletis. For ASC22 (KN035) in viral indications worldwide outside Greater China, Ascletis will be eligible to share certain economics such as upfront, milestone payments and royalties, depending on the development and regulatory status of ASC22 (KN035) inside Greater China.

KN035, as a PD-L1 single domain antibody Fc fusion, has the advantages of subcutaneous injection and good stability at room temperature. These would be of great value to improve patients' compliance and quality of life and to help realize the goal of long-term management of cancer as a chronic disease.

With the close collaboration between Alphamab (together with its affiliate Jiangsu Alphamab Biopharmaceuticals Co., Ltd.) and 3D Medicines (Beijing) Co., Ltd, to date, KN035 has been studied in multiple clinical trials with more than 500 patients exposed in U.S, China and Japan. KN035 has entered into two pivotal trials and demonstrated good safety profile and encouraging preliminary efficacy.

Ascletis is addressing unmet medical needs in three therapeutic areas: anti-viral, cancer and fatty liver disease.

Suzhou Alphamab is focused on research and development of mAbs, fusion proteins and other biological macromolecule drugs. With multiple proprietary platforms in antibody screening, protein engineering, CMC development and pilot production set up in its 6000m2 laboratory in Biobay Suzhou, Alphamab has created a pipeline of over 20+ novel biologics. Alphamab aims to develop affordable and efficient biological drugs to address high unmet medical needs globally.