抗PD - 1单抗皮下制剂
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港股异动 | 君实生物(01877)再涨超5% 特瑞普利单抗皮下注射III期临床达主要终点 后续拟申报上市
Zhi Tong Cai Jing· 2025-11-26 03:33
消息面上,君实生物宣布,由公司自主研发的特瑞普利单抗注射液(皮下注射)(产品代号:JS001sc)对比 特瑞普利单抗注射液(产品代号:JS001)联合化疗一线治疗复发或转移性非鳞状非小细胞肺癌(NSCLC)的 多中心、开放、随机对照Ⅲ期临床研究达到主要研究终点。君实生物计划将于近期向监管部门递交该产 品的上市许可申请。 公开资料显示,JS001sc是公司在已上市产品特瑞普利单抗注射液的基础上开发的皮下注射制剂,为首 款进入III期临床研究阶段的国产抗 PD-1 单抗皮下制剂,有望给患者带来用药的便捷性。 智通财经APP获悉,君实生物(01877)再涨超5%,截至发稿,涨4.43%,报25.48港元,成交额4614.77万 港元。 ...
君实生物再涨超5% 特瑞普利单抗皮下注射III期临床达主要终点 后续拟申报上市
Zhi Tong Cai Jing· 2025-11-26 03:14
消息面上,君实生物宣布,由公司自主研发的特瑞普利单抗注射液(皮下注射)(产品代号:JS001sc)对比 特瑞普利单抗注射液(产品代号:JS001)联合化疗一线治疗复发或转移性非鳞状非小细胞肺癌(NSCLC)的 多中心、开放、随机对照Ⅲ期临床研究达到主要研究终点。君实生物计划将于近期向监管部门递交该产 品的上市许可申请。 公开资料显示,JS001sc是公司在已上市产品特瑞普利单抗注射液的基础上开发的皮下注射制剂,为首 款进入III期临床研究阶段的国产抗PD-1单抗皮下制剂,有望给患者带来用药的便捷性。 君实生物(01877)再涨超5%,截至发稿,涨4.43%,报25.48港元,成交额4614.77万港元。 ...
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]