Akeso (09926.HK) announcement, the National Medical Products Administration (NMPA) of China has recently officially accepted the company's independently developed global first innovative bispecific antibody Idaferolizumab (PD-1/VEGF) monotherapy as a new indication in the market application (sNDA) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with positive PD-L1 expression (PD-L1 TPS≥1%).

This sNDA is based on AK112-303/HARMONi-2, and the mid-term analysis of this study has achieved strong positive results. In the intention-to-treat population (ITT), Idaferolizumab monotherapy significantly prolonged progression-free survival (PFS) and hazard ratio (HR) was significantly better than expected compared to single-agent Paborelizumab.

Idaferolizumab has become the world's first and only drug that has been proved to be significantly superior to Paborelizumab in a head-to-head Phase III clinical study in monotherapy. Idaferolizumab will also become the new standard of care for first-line treatment of lung cancer without chemotherapy.

It is reported that Idaferolizumab is an independently developed global first PD-1/VEGF bispecific tumor immunotherapy drug. Idaferolizumab was approved by the NMPA for marketing on May 24, 2024, for the treatment of locally advanced or metastatic non-squamous NSCLC with EGFR mutations that have progressed after EGFRTKI treatment. Currently, Idaferolizumab has been approved for one indication in China, and 5 Phase III clinical studies are underway, including 2 international multicenter Phase III clinical studies and 4 Phase III registration clinical studies with PD-1 monoclonal antibody as positive control drugs. Idaferolizumab clinical trials cover 16 indications, including gastrointestinal tumors, liver cancer, and colorectal cancer.