君实生物(688180.SH):关于 JS001sc 一线治疗非鳞状非小细胞肺癌的Ⅲ期临床研究达到主要研究终点
Ge Long Hui·2025-11-24 20:16

Core Viewpoint - Junshi Biosciences (688180.SH) announced that its product Toripalimab injection (subcutaneous) has achieved the primary endpoint in a Phase III clinical study for the treatment of recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy [1][2] Group 1: Clinical Research - The JS001sc-002-III-NSCLC study is a multicenter, open-label, randomized controlled Phase III clinical trial, marking the first Phase III clinical study for a domestic PD-1 subcutaneous formulation [2] - The study aims to compare the drug exposure, efficacy, and safety of JS001sc and Toripalimab injection in patients with recurrent or metastatic non-squamous NSCLC [2] - Results indicate that the drug exposure of JS001sc is non-inferior to that of Toripalimab injection, with similar efficacy and safety profiles for both treatments [2] Group 2: Market Context - According to GLOBOCAN 2022, there were 1.06 million new lung cancer cases in China in 2022, accounting for 22.0% of all new cancer cases, with lung cancer deaths reaching 730,000, representing 28.5% of cancer deaths [1] - Non-small cell lung cancer (NSCLC) constitutes approximately 85% of all lung cancer cases, with non-squamous NSCLC patients making up about 65% of NSCLC cases [1] - There is a pressing clinical need to enhance the convenience of immunotherapy, as current domestic immunotherapy drugs are primarily intravenous formulations, which are time-consuming and inconvenient for patients [2]