Akeso has received the National Center for Drug Evaluation of the State Drug Administration of the People's Republic of China’s (NMPA CDE) priority review of new drug application (NDA) for its antibody ivonescimab.
Ivonescimab is a potential first-in-class investigational PD-1/VEGF bi-specific antibody.
It is the company’s other new antibody with a priority review following the marketing approval of cadonilimab.
After the China CDE accepted marketing application of ivonescimab, the company has initiated or is conducting four pivotal registrational Phase III studies globally.
Akeso entered into a partnership and license agreement in December last year for up to $5bn with Summit Therapeutics.
The company out-licensed exclusive rights to ivonescimab to Summit to develop and commercialise in the US, Europe, Canada, and Japan.
Akeso agreed to retain rights for its development and commercialisation for the rest of the world including China.
Earlier, ivonescimab received breakthrough therapy designation (BTD) from CDE for three lung cancer indications.
On 1 August 2023, the first NDA was accepted by the CDE for ivonescimab.
The priority review process serves as a milestone for the clinical value recognition of ivonescimab. This is expected to accelerate the approval and marketing process of ivonescimab.
Ivonescimab, which combines the effects of immunotherapy through a blockade of PD-1 with the anti-angiogenesis effects, is believed to be the PD-1 / VEGF bispecific antibody.
This antibody is engaged in several Phase III studies across the globe at present.
Akeso is focused on the development and commercialisation of first-in-class and best-in-class medicines globally.