Summit Therapeutics, Inc. has a definitive partnership with Akeso Inc. (HKEX Code: 9926.HK, “Akeso”), to in-license its breakthrough bispecific antibody, ivonescimab. Akeso is a pioneer and source originator in developing innovative antibodies. The agreement supports Summit’s mission of developing and commercializing groundbreaking oncology pipeline products aimed at improving the quality of life of patients with serious unmet medical needs. For Akeso, the deal represents an opportunity to introduce its highly innovative antibodies to markets, including the United States, Canada, Europe, and Japan – an important step towards Akeso’s strategic intention of becoming a global biopharma organization. Ivonescimab is an investigational therapy that is not approved by any regulatory authority.

Ivonescimab, known as AK112 in China and non-Summit territories, and also as SMT112 in the United States, Canada, Europe, and Japan (Summit License Territories), is a novel, potential first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking of VEGF into a single molecule. Ivonescimab is the most advanced PD-1/VEGF bispecific antibody in clinical development in the Summit License Territories: there are no known PD-1-based bispecific antibodies approved by the U.S. Food and Drug Administration (“FDA”) or the European Medicines Agency (“EMA”). ​A New Drug Application (“NDA”) of ivonescimab has been accepted by the Center for Drug Evaluation of the National Medical Products Administration (“NMPA CDE”) of China in August 2023, and granted Priority Review Designation.