{"id":21501,"date":"2023-08-25T12:00:00","date_gmt":"2023-08-25T12:00:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4193019_CN93019_0"},"modified":"2023-08-25T12:00:00","modified_gmt":"2023-08-25T12:00:00","slug":"akeso-announced-that-ivonescimab-granted-priority-review-of-nda-by-china-nmpa","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=21501","title":{"rendered":"Akeso Announced that Ivonescimab Granted Priority Review of NDA by China NMPA"},"content":{"rendered":"
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HONG KONG<\/span><\/span>, Aug. 25, 2023<\/span><\/span> \/PRNewswire\/ — Akeso Inc. (“Akeso”, the “Company”; 9926.HK), a commercial-stage biopharmaceutical company focused on developing and commercializing first-in-class and best-in-class innovative medicines globally, announced today that the National Center for Drug Evaluation of the State Drug Administration of the People’s Republic of China<\/span> (NMPA CDE) has granted priority review of New Drug Application (NDA) for ivonescimab, a potential first-in-class investigational PD-1\/VEGF bi-specific antibody.<\/p>\n

In December 2022<\/span>, Akeso entered into a collaboration and license agreement for up to US$5 billion<\/span> with Summit Therapeutics(“Summit”). Akeso out-licensed to Summit exclusive rights to ivonescimab (PD-1\/VEGF) for the development and commercialization in the United States<\/span>, Canada<\/span>, Europe<\/span>, and Japan<\/span>. Akeso will retain development and commercialization rights for the rest of the world including China<\/span>. Ivonescimab is known as AK112 for Akeso’ R&D code at China<\/span> and Australia<\/span>, and as SMT112 for Summit’s license territories.<\/p>\n

Previously, CDE has granted Breakthrough Therapy Designation (BTD) for ivonescimab for three lung cancer indications. On August 1, 2023<\/span>, the first NDA for ivonescimab was accepted by the CDE. The Priority Review process for ivonescimab is a milestone for the clinical value recognition of ivonescimab, which will expedite the process of approval and marketing of ivonescimab.<\/p>\n

Ivonescimab is Akeso’s other novel bispecific antibody with a priority review following the marketing approval of cadonilimab (PD-1\/CTLA-4 bispecific antibody). Prior to this, the review process for cadonilimab<\/span> under Priority Review took only 9 months to complete, making it the world’s first approved bispecific antibody drug for cancer immunotherapy.<\/p>\n

Following an acceptance of marketing application of ivonescimab by the China CDE, four pivotal registrational Phase III clinical trials have been initiated\/are being conducted worldwide, including three head-to-head trials with PD-1 monoclonal antibody as the positive control drug:<\/p>\n