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君实生物(01877):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
Zhi Tong Cai Jing· 2025-11-24 12:46
Core Viewpoint - Junshi Biosciences (01877) announced that its product JS001sc (subcutaneous injection of Toripalimab) 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, paving the way for a forthcoming market application submission [1]. Group 1 - The clinical study (JS001sc-002-III-NSCLC) is a multicenter, open-label, randomized controlled trial comparing JS001sc with Toripalimab injection (JS001) in combination with chemotherapy [1]. - JS001sc is the first domestically developed subcutaneous PD-1 monoclonal antibody to enter Phase III clinical trials, potentially offering patients greater convenience in medication administration [1]. - The company plans to submit a marketing authorization application to regulatory authorities in the near future [1].
君实生物(688180.SH):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
智通财经网· 2025-11-24 11:07
Core Viewpoint - Junshi Biosciences (688180.SH) announced that its product JS001sc, a subcutaneous injection of Toripalimab, has met the primary endpoint in a Phase III clinical trial for the treatment of recurrent or metastatic non-squamous non-small cell lung cancer, and plans to submit a marketing authorization application soon [1] Group 1 - The clinical trial (JS001sc-002-III-NSCLC) is a multicenter, open-label, randomized controlled study comparing JS001sc with Toripalimab injection (trade name: Tuoyi®) in combination with chemotherapy [1] - JS001sc is developed based on the already marketed Toripalimab injection and is the first domestic PD-1 monoclonal antibody subcutaneous formulation to enter Phase III clinical trials [1] - The new formulation is expected to provide convenience for patients in terms of medication administration [1]