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]

Market Overview - The A-share pharmaceutical and biotechnology index fell by 4.32%, underperforming the CSI 300 index by 0.54 percentage points, and outperforming the ChiNext index by 1.92 percentage points, ranking 30th among 31 sub-industries [4] - The H-share Hang Seng Healthcare Index dropped by 7.5%, underperforming the Hang Seng Index by 2.41 percentage points [4] R&D Progress - Recent IND applications were initiated for HRS-1358 and HRS-3738 by Heng Rui Medicine; clinical applications for SHR-9539 and JS207 were also newly initiated [5] - TQB2934 by Zhengda Tianqing is currently in Phase I clinical trials; Gan Li Pharmaceutical's Bofan Glutide is in Phase III clinical trials [5] Industry Insights - The small nucleic acid drug sector is experiencing significant advancements, indicating a potential wave of next-generation innovative drugs [6] - Since 2025, breakthroughs in delivery technology are expected to expand indications from the liver to cardiovascular and CNS areas, coupled with the commercialization of major products and substantial mergers by multinational pharmaceutical giants [6] - The industry is entering a golden development period driven by "technological breakthroughs + commercial realization" [6] - Domestic pharmaceutical companies are accelerating R&D progress, with many entering clinical research phases since 2025; focus is recommended on leading innovative drug companies with advanced technology platforms and differentiated pipelines, as well as innovative industry chain companies likely to benefit from overall industry upturn [6] Investment Strategy - The investment strategy for the pharmaceutical sector in 2026 emphasizes the importance of clinical value, addressing clinical needs of patients [7] - Both domestic medical insurance policies and global expansion strategies are increasingly assigning higher premiums to clinical value [7]

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]

Major Events - Leapmotor (09863) has been included in the Hang Seng Tech Index [1] - Yipai Sunshine (02522) signed a strategic framework cooperation agreement with the government of Qingyang and Yinghe Yimai [1] - China Coalbed Methane (08270) plans to sell 100% equity of Shanxi Qingshui Shuntai Energy Development for 24.6093 million yuan [1] - Huayou Energy (01251) successfully won the development rights for six blocks in the Talara oil field in Peru [1] - Xian Construction (01500) issued a profit warning, expecting mid-term comprehensive profit to be around 25 to 30 million HKD, turning from loss to profit year-on-year [1] - Junshi Biosciences (01877): JS001sc's Phase III clinical trial for first-line treatment of non-squamous non-small cell lung cancer achieved its primary endpoint [1] Operating Performance - WeRide (00800) reported third-quarter revenue growth of 144% to 171 million yuan year-on-year [1] - China Wangwang (00151) announced mid-term results with profit attributable to equity holders of approximately 1.717 billion yuan, a decrease of 7.8% year-on-year [1] - Yike (09923) reported a 50% quarter-on-quarter increase in overseas payment transaction volume for the third quarter [1] - Cathay Pacific (00293): Cathay Pacific and Hong Kong Express carried over 3.2 million passengers in October, a month-on-month increase of 21% [1] - Kingold International (00009) released mid-term results with a profit attributable to shareholders of 198 million HKD, turning from loss to profit year-on-year [1]

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]