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]

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。截至本公告披露日，一项对比 JS001sc和特瑞普利单抗注射液联合化疗一线治疗复发或转移性非鳞状非小细胞肺癌的多中心、开放、 随机对照III期临床研究(JS001sc-002-III-NSCLC研究)已达到主要研究终点。 格隆汇11月24日丨君实生物(01877.HK)公告，近日，上海君实生物医药科技股份有限公司(以下简称"公 司")产品特瑞普利单抗注射液(皮下注射)(代号：JS001sc)对比特瑞普利单抗注射液(商品名：拓益®，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的多中心、开放、随机对照III期临 床研究(JS001sc-002-III-NSCLC研究，NCT06505837)达到主要研究终点。公司计划将于近期向监管部门 递交该产品的上市许可申请。由于药品的研发周期长、审批环节多，容易受到一些不确定性因素的影 响，敬请广大投资者谨慎决策，注意防范投资风险。 ...

Core Viewpoint - Junshi Bioscience (688180.SH/1877.HK) reported significant improvement in operational performance in the first half of 2025, with revenue reaching 1.168 billion yuan, a 49% year-on-year increase, and a 36% reduction in net loss to 413 million yuan, indicating enhanced sustainability in operations [1] Group 1: Financial Performance - In the first half of 2025, Junshi Bioscience achieved drug sales revenue of 1.059 billion yuan, also a 49% increase year-on-year, reflecting strengthened commercialization capabilities [1] - The core product, Toripalimab (Tuoyi®), generated sales revenue of 954 million yuan in the domestic market, marking a 42% year-on-year growth [1] - As of the end of Q2, the company had a total of 3.507 billion yuan in cash and financial assets, indicating a strong liquidity position [3] Group 2: Product Development and Market Expansion - Toripalimab's inclusion in the National Medical Insurance Directory expanded to 10 indications, with new approvals for the 11th and 12th indications in mainland China [1] - The product has been approved for sale in 40 countries and regions across four continents, including recent approvals in Australia, Singapore, UAE, and Kuwait [1][7] - The company has established commercial partnerships in over 80 countries, enhancing its global commercialization network [6] Group 3: R&D and Pipeline Progress - Junshi Bioscience increased its R&D investment to 706 million yuan in the first half of 2025, a 29% year-on-year increase, focusing on high-potential projects [8] - The company is advancing its PD-1/VEGF dual antibody (JS207) in Phase II clinical trials, targeting various cancers [9] - The company is also developing JS213, a PD-1/IL-2 dual functional antibody, currently in I phase clinical trials [9] - The innovative research institute was established to consolidate resources for R&D, enhancing operational efficiency [8]