Bei Jing Ri Bao Ke Hu Duan·2025-07-16 13:03Group 1 - The National Medical Products Administration (NMPA) has accepted the marketing application for Baiyue Shenzhou's Talatuzumab injection, which is intended for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have failed at least second-line treatment [1] - Talatuzumab is a first-in-class DLL3/CD3 bispecific antibody that may bring breakthrough advancements in the treatment of SCLC, a type of lung cancer with a high rate of incidence and mortality [1][2] - SCLC accounts for approximately 15% of all lung cancer cases, with about 70% of patients diagnosed at the extensive stage, leading to a median overall survival (mOS) of only 4 to 5 months after initial treatment [1] Group 2 - DLL3 protein is considered a highly attractive therapeutic target in SCLC, with up to 96% of SCLC patients expressing this protein [2] - Talatuzumab utilizes an innovative T-cell engaging (BiTE) structure, which allows for effective targeting of tumor cells and T-cells, potentially making it a novel therapy for SCLC [2] - Interim analysis from a global Phase 3 clinical trial presented at the 2025 American Society of Clinical Oncology annual meeting showed that Talatuzumab treatment resulted in a median overall survival of 13.6 months, significantly extending survival by 5.3 months compared to standard chemotherapy [2]