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 Insights - Junshi Biosciences (01877) reported a revenue of 1.806 billion RMB for the first three quarters of 2025, representing a year-on-year growth of 42.06% [1] - The net loss attributable to shareholders narrowed to 596 million RMB, a decrease of 35.7% compared to the previous year [1] - The basic loss per share was 0.60 RMB [1] Revenue Growth - The increase in revenue was primarily driven by the sales of commercialized drugs, with the core product Toripalimab injection (brand name: Tuoyi/LOQTORZI, product code: JS001) generating approximately 1.495 billion RMB in sales in the domestic market, reflecting a year-on-year growth of about 40% [1] Cost Management - The company is implementing a "quality improvement and efficiency enhancement" action plan, focusing on cost control and resource allocation, which has significantly reduced the loss amount compared to the same period last year [1] Financial Position - As of the end of the reporting period, the company had a total balance of cash and trading financial assets amounting to 3.270 billion RMB, indicating a strong liquidity position [1]