Biopharmaceutical company Akeso announced that its ivonescimab has obtained priority review of New Drug Application (NDA) from the National Center for Drug Evaluation of the State Drug Administration of the People’s Republic of China (NMPA CDE).
Ivonescimab is a possible first-in-class investigational PD-1/VEGF bi-specific antibody.
US-based Summit Therapeutics and Akeso agreed on a collaboration and license deal for up to $5bn in December 2022.
China-based Akeso out-licensed to Summit exclusive rights to ivonescimab for the development and commercialisation in the US, Canada, Europe, and Japan.
The rights to development and commercialisation for the rest of the globe, including China, remained with Akeso.
Ivonescimab is marketed in China, Australia, and other R&D markets under the trade names AK112 for Akeso and SMT112 for Summit.
The PD-1/VEGF bi-specific antibody has already received a Breakthrough Therapy Designation (BTD) for three indications related to lung cancer.
The CDE approved the initial NDA for ivonescimab on August 1st, 2023. Its priority review procedure will help validate its clinical significance and will accelerate the drug’s approval and marketing procedures.
After cadonilimab, a PD-1/CTLA-4 bispecific antibody that received marketing approval, ivonescimab is another bispecific antibody from Akeso which received a priority evaluation.
Prior to this, cadonilimab’s priority review procedure took just nine months to wrap up, making it the first bispecific antibody medication for cancer immunotherapy to receive approval worldwide, the biopharmaceutical company claimed.
Following this recent announcement, Akeso has started or been conducting four registrational Phase 3 clinical trials globally. It includes three head-to-head studies with PD-1 monoclonal antibody as the positive control drug.
The Chinese company is currently working on a portfolio of over 30 assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease, and other therapeutic areas.
Out of 30 assets, 19 assets have entered the clinical stage and three drugs have been authorised.
Furthermore, Akeso internally discovered and developed an oncology product, penpulimab. It received marketing approval in China in August 2021.