本公告由上海君實生物醫藥科技股份有限公司（「本公司」）自願作出。請亦參見本 公司於2025年10月16日刊發的海外監管公告。 本公司董事（「董事」）會（「董事會」）欣然宣佈，本公司產品重組人源化抗PD-1和 VEGF雙特異性抗體（代號：JS207）對比納武利尤單抗用於II/III期、可切除、可改 變驅動基因(AGA)陰性非小細胞肺癌患者新輔助治療的開放標籤、雙臂、隨機、 陽性對照II/III期臨床研究（「本次研究」）的臨床試驗申請獲得美國食品藥品監督管 理局(FDA)批准。 關於JS207 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。 SHANGHAI JUNSHI BIOSCIENCES CO., LTD.* 上海君實生物醫藥科技股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1877） 自願性公告－ JS207用於非小細胞肺癌患者新輔助治療的 II/III期臨床試驗申請獲得FDA批准 JS207為本公司自主研發的重組人源化 ...

Core Viewpoint - The company has received FDA approval for its clinical trial application for JS207, a bispecific antibody targeting PD-1 and VEGF, aimed at treating resectable, AGA-negative non-small cell lung cancer (NSCLC) patients in a Phase II/III study [1][2]. Company Summary - JS207 is a recombinant humanized bispecific antibody designed to target PD-1 and VEGF, developed independently by the company, primarily for the treatment of advanced malignancies [1]. - The antibody has high affinity for both PD-1 and VEGFA, effectively blocking the interaction between PD-1 and its ligands, as well as inhibiting VEGF from binding to its receptors [1]. - JS207 combines the therapeutic effects of immunotherapy and anti-angiogenic therapy, improving the tumor microenvironment and enhancing the infiltration of cytotoxic T lymphocytes, thereby achieving better anti-tumor activity [1][2]. Clinical Research Summary - The clinical trial is an open-label, two-arm, randomized, positive-controlled Phase II/III study comparing the efficacy and safety of JS207 with Nivolumab in NSCLC patients [3]. - This study marks the first confirmatory research for a PD-1/VEGF dual-target drug in a surgical population, led by Professor Wu Yilong from Guangdong Provincial People's Hospital [3]. - The company is also conducting multiple Phase II clinical studies exploring JS207 in various cancers, including NSCLC, colorectal cancer, triple-negative breast cancer, and liver cancer, in combination with chemotherapy and other therapies [2]. Industry Context - Lung cancer remains the leading cause of cancer incidence and mortality globally, with approximately 2.48 million new cases and 1.82 million deaths reported in 2022 [3]. - Non-small cell lung cancer (NSCLC) accounts for about 85% of all lung cancer cases, with 20% to 25% of patients being eligible for surgical resection at diagnosis [3]. - Despite advancements in treatment, there remains an unmet clinical need for improved survival rates and cure rates in resectable NSCLC patients [3].

Core Viewpoint - Junshi Biosciences' application for a Phase II/III clinical trial of JS207 for neoadjuvant treatment in patients with non-small cell lung cancer has been approved by the FDA [1] Group 1: Company Information - Junshi Biosciences (688180.SH) announced the FDA approval for its clinical trial application of JS207, a recombinant humanized anti-PD-1 and VEGF bispecific antibody [1] - JS207 is designed to block the binding of PD-1 to PD-L1 and PD-L2, as well as inhibit the binding of VEGF to its receptors, showcasing both immunotherapy and anti-angiogenesis properties [1] Group 2: Industry Context - This study marks the first time a PD-1/VEGF dual-target drug has been approved for confirmatory research in a surgically resectable population [1]