康方生物双抗依沃西一线治疗NSCLC在中国获批上市

Core Insights - Kangfang Biopharma announced the approval of its independently developed PD-1/VEGF bispecific antibody drug, Iwosimab (generic name: Iwosimab injection), for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with PD-L1 positive (TPS≥1%) and negative EGFR mutations and ALK [1][2] - Iwosimab is the first drug to achieve significant positive results in a head-to-head Phase III clinical study against the leading drug, Pembrolizumab, providing a new, more efficient, and safer "chemotherapy-free" treatment option for first-line NSCLC [1] - The approval of Iwosimab for first-line treatment of PD-L1 positive NSCLC marks its second indication, allowing Chinese patients to access the world's best treatment options first [1] Clinical Recognition and Future Prospects - Iwosimab has gained widespread recognition among clinicians and patients for its efficacy in treating EGFR-TKI resistant NSCLC since its market launch nearly a year ago [2] - Recent Phase III studies comparing Iwosimab combined with chemotherapy against Tremelimumab combined with chemotherapy for first-line treatment of squamous NSCLC have also shown significant positive results, establishing Iwosimab as a new standard treatment [2] - Kangfang Biopharma's founder, Dr. Xia Yu, highlighted that Iwosimab has a forward-looking layout in multiple core tumor immunotherapy indications, with nearly 30 clinical studies underway, including Phase III and Phase II trials, covering nearly 20 indications, creating a leading advantage for its clinical and commercial value globally [2]