Core Viewpoint - The company has initiated a bridging trial in Japan for its drug Hanshuo® (sulunatuzumab injection) in combination with chemotherapy for the treatment of extensive-stage small cell lung cancer (ES-SCLC) patients, aiming to support future market approval in Japan [1][2] Group 1 - The bridging trial is a single-arm, open-label, phase 2 study conducted in Japan, where eligible patients will receive Hanshuo® combined with chemotherapy (carboplatin - etoposide) every three weeks [2] - The primary objective of the study is to evaluate the efficacy of Hanshuo® in combination with chemotherapy in first-line treatment of ES-SCLC patients, while secondary objectives include assessing safety, pharmacokinetics, and immunogenicity [2] - The main endpoint of the study is the response rate at 24 weeks, which includes complete response (CR) or partial response (PR), with secondary endpoints including overall survival (OS), progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), quality of life, safety, pharmacokinetics, and immunogenicity metrics [2]
复宏汉霖(02696.HK)：汉斯状®(斯鲁利单抗注射液)联合化疗一线治疗广泛期小细胞肺癌(ES-SCLC)的日本桥接试验完成首例患者给药