Biopharmaceutical company Akeso Inc. (AKESF) announced Monday that China's National Medical Products Administration or NMPA has accepted the supplementary New Drug Application or sNDA for ivonescimab (PD-1/VEGF bispecific antibody) in combination with chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer or sq-NSCLC.
The decision is based on positive outcomes from the Phase III HARMONi-6 study, which demonstrated the superiority of ivonescimab combined with chemotherapy over existing treatments.
The latest approval is the third accepted application for ivonescimab in China. Previous filings were for its combination therapy in EGFR-TKI resistant locally advanced or metastatic non-squamous NSCLC (nsq-NSCLC), as well as its monotherapy for first-line treatment of PD-L1 positive advanced NSCLC.
Ivonescimab is currently involved in over 12 registrational/Phase III clinical trials worldwide, further establishing its role in global cancer immunotherapy. These include six head-to-head studies with PD-1/L1 inhibitors.
The trials are on various malignancies, including various subtypes of lung cancer, first-line colorectal cancer, first-line head and neck squamous cell carcinoma, first-line biliary tract cancer, first-line pancreatic cancer, and first-line triple-negative breast cancer, among others.
For More Such Health News, visit rttnews.com
For comments and feedback contact: editorial@rttnews.com
Health News
May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.