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。 智通财经APP获悉，君实生物(01877)现涨近5%，截至发稿，涨4.71%，报24.92港元，成交额3254.28万 港元。 公告显示，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。 ...

Core Insights - Junshi Biosciences announced that its JS001sc-002-III-NSCLC study has met its primary endpoints, indicating a successful Phase 3 clinical trial for its subcutaneous formulation of toripalimab in treating recurrent or metastatic non-squamous non-small-cell lung cancer [1][5] - The company plans to submit a new drug application (NDA) to regulatory authorities soon, aiming to enhance treatment accessibility and convenience for patients [1][6] Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company founded in December 2012, focusing on the discovery, development, and commercialization of novel therapies [8] - The company has a diversified R&D pipeline with over 50 drug candidates across five therapeutic areas, including cancer, autoimmune, metabolic, neurological, and infectious diseases [8] - It has received approvals for five products in China and international markets, including toripalimab, which is China's first domestically produced anti-PD-1 monoclonal antibody [9] Industry Context - In 2022, China reported 1.06 million new lung cancer cases, with non-small-cell lung cancer (NSCLC) being the predominant subtype, accounting for approximately 85% of cases [2] - Immunotherapy, particularly anti-PD-1 monoclonal antibodies, has become a cornerstone treatment for various cancers, including lung cancer, addressing a significant clinical need for more convenient administration methods [3][4]

Core Insights - Junshi Biosciences announced that its JS001sc-002-III-NSCLC study has met its primary endpoints, indicating a successful Phase 3 clinical trial for its subcutaneous formulation of toripalimab in treating recurrent or metastatic non-squamous non-small-cell lung cancer (NSQ-NSCLC) [1][5] - The company plans to submit a new drug application (NDA) to regulatory authorities soon, aiming to enhance treatment accessibility and convenience for patients [1][6] Company Overview - Junshi Biosciences, founded in December 2012, is an innovation-driven biopharmaceutical company focused on discovering, developing, and commercializing novel therapies, with a diverse R&D pipeline of over 50 drug candidates [8][10] - The company has five therapeutic focus areas: cancer, autoimmune, metabolic, neurological, and infectious diseases, and has received approvals for five products in China and international markets [9][8] Clinical Study Details - The JS001sc-002-III-NSCLC study is a multi-center, open-label, randomized Phase 3 clinical trial led by Professor Lin WU from Hunan Cancer Hospital, marking the first Phase 3 study of a domestic anti-PD-1 monoclonal antibody subcutaneous formulation [4][7] - The study results showed that the drug exposure of JS001sc was non-inferior to that of the intravenous formulation, with comparable efficacy and safety profiles [5][6] Market Context - In 2022, China reported 1.06 million new lung cancer cases, with non-small-cell lung cancer (NSCLC) being the predominant subtype, accounting for approximately 85% of cases [2] - Immunotherapy, particularly anti-PD-1 monoclonal antibodies, has become a cornerstone treatment for various cancers, highlighting the urgent need for more convenient administration methods [3][6]

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]

Core Viewpoint - Junshi Biosciences (688180) announced that its product Toripalimab injection (subcutaneous) (code: JS001sc) achieved the primary research endpoint in a Phase III clinical study for the treatment of recurrent or metastatic non-squamous non-small cell lung cancer in combination with chemotherapy, compared to Toripalimab injection (trade name: Tuoyi, product code: JS001) [1] Group 1 - The company plans to submit a marketing authorization application for JS001sc to regulatory authorities in the near future [1] - JS001sc is developed based on the already marketed product Toripalimab injection and is the first domestic PD-1 monoclonal antibody subcutaneous formulation to enter Phase III clinical research [1] - The new formulation is expected to provide convenience for patients in terms of medication administration [1]

SHANGHAI JUNSHI BIOSCIENCES CO., LTD.* 上海君實生物醫藥科技股份有限公司 自願性公告－ JS001sc一線治療非鱗狀非小細胞肺癌的III期臨床研究達到主要研究終點 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1877） JS001sc-002-III-NSCLC研究是一項多中心、開放、隨機對照的III期臨床研究，為 國產PD-1藥物皮下製劑的首個III期臨床研究，由湖南省腫瘤醫院鄔麟教授擔任主 要研究者。該研究旨在比較JS001sc和特瑞普利單抗注射液聯合化療在復發或轉移 性非鱗狀非小細胞肺癌中的藥物暴露量、有效性和安全性。結果表明，JS001sc的 藥物暴露量非劣效於特瑞普利單抗注射液的藥物暴露量，兩者的療效和安全性均 相似。本研究的詳細數據將在近期的國際學術大會上公佈。本公司計劃與監管部 門溝通後，遞交JS001sc用於拓益®所獲批的全部適應症的上市 ...

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].

Core Viewpoint - The company announced that its product, JS001sc (subcutaneous injection of Tislelizumab), has achieved 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: Clinical Trial Results - The Phase III clinical study (JS001sc-002-III-NSCLC) comparing JS001sc with Tislelizumab injection (brand name: Tuoyi®) in combination with chemotherapy has reached its primary endpoint [1] - JS001sc is the first domestically developed subcutaneous PD-1 monoclonal antibody to enter Phase III clinical trials, potentially offering convenience for patients [1] Group 2: Regulatory Plans - The company intends to submit a marketing authorization application to regulatory authorities in the near future [1] Group 3: Product Development - JS001sc is developed based on the already marketed Tislelizumab injection, indicating a strategic expansion of the company's product line [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 SHANGHAI JUNSHI BIOSCIENCES CO., LTD.* 上海君實生物醫藥科技股份有限公司 承董事會命 上海君實生物醫藥科技股份有限公司 熊俊先生 主席 中國，上海，2025年11月24日 於本公告日期，本公司董事會包括執行董事熊俊先生、李寧博士、鄒建軍博士、 李聰先生、張卓兵先生、姚盛博士、王剛博士及李鑫博士；非執行董事湯毅先 生；以及獨立非執行董事張淳先生、馮曉源博士、酈仲賢先生、魯琨女士及楊勁 博士。 * 僅供識別之用 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1877） 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條規則作出。 茲載列上海君實生物醫藥科技股份有限公司在上海證券交易所網站刊發之《上海 君實生物醫藥科技股份有限公司自願披露關於JS001sc一線治療非鱗狀非小細胞肺 癌的III期臨床研究達到主要研究終點的公告》，僅供參閱。 ...

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]