Core Viewpoint - Junshi Biosciences (01877) experienced a nearly 5% increase in stock price following the announcement of FDA approval for its clinical trial application for JS207, a dual-specific antibody targeting PD-1 and VEGF for the treatment of non-small cell lung cancer [1][2]. Group 1: Product Development - JS207 is a recombinant humanized dual-specific antibody targeting PD-1 and VEGF, developed by the company for the treatment of advanced malignancies [1]. - The antibody effectively blocks the binding of PD-1 to PD-L1 and PD-L2, as well as the binding of VEGF to its receptors, showcasing both immunotherapy and anti-angiogenesis properties [1]. - The drug aims to improve the tumor microenvironment by inhibiting endothelial cell proliferation and increasing the infiltration of cytotoxic T lymphocytes, thereby enhancing anti-tumor activity [1]. Group 2: Clinical Research - As of the announcement date, JS207 has been approved to enter the Phase II/III clinical research stage, with multiple ongoing Phase II studies exploring its use in various cancers, including non-small cell lung cancer, colorectal cancer, triple-negative breast cancer, and liver cancer [2]. - The ongoing studies are investigating combinations of JS207 with chemotherapy, monoclonal antibodies, and antibody-drug conjugates (ADCs) [2].

Group 1 - Junshi Biosciences' JS207 received FDA approval for a Phase II/III clinical trial targeting neoadjuvant treatment in resectable, driver gene-negative non-small cell lung cancer patients, enhancing its international expansion and market potential [1] Group 2 - Eli Lilly's oral GLP-1 drug orforglipron demonstrated significant efficacy in two Phase III trials, achieving primary and all key secondary endpoints, including notable reductions in HbA1c, weight loss, and improvements in cardiovascular risk factors, reinforcing its competitive position in the GLP-1 market [2] Group 3 - Guobang Pharmaceutical reported a 23.17% year-on-year increase in net profit for Q3, despite a 5.39% decline in revenue, attributed to improved sales collection and optimized procurement payments, showcasing strong profitability resilience [3] Group 4 - Zhijiang Biopharmaceutical announced a share buyback plan of 60 million to 120 million yuan to support employee stock ownership plans or equity incentives, reflecting confidence in long-term development and aiming to strengthen core team commitment [4]

证券日报网讯 10月16日晚间，君实生物发布公告称，近日，公司产品重组人源化抗PD-1和VEGF双特异 性抗体（代号：JS207）对比纳武利尤单抗用于Ⅱ/Ⅲ期、可切除、可改变驱动基因（AGA）阴性非小细 胞肺癌患者新辅助治疗的开放标签、双臂、随机、阳性对照Ⅱ/Ⅲ期临床研究的临床试验申请获得美国 食品药品监督管理局（FDA）批准。 （编辑 任世碧） ...

Core Viewpoint - Junshi Biosciences has received FDA approval to conduct a Phase II/III study comparing JS207 (a PD-1/VEGF dual antibody) with Nivolumab for neoadjuvant treatment in patients with resectable, AGA-negative non-small cell lung cancer (NSCLC) [1][2] Group 1: Study Overview - The study is an open-label, two-arm, randomized, positive-controlled international multicenter Phase II/III trial aimed at comparing the efficacy and safety of JS207 and Nivolumab in patients with resectable, AGA-negative NSCLC [2] - This marks the first confirmatory study of a PD-1/VEGF dual-target drug in a surgical population, led by Professor Wu Yilong from Guangdong Provincial People's Hospital [2] Group 2: Clinical Context - Lung cancer is the most prevalent and deadly malignancy globally, with approximately 2.48 million new cases and 1.82 million deaths reported in 2022 [1] - NSCLC accounts for about 85% of all lung cancer cases, with 20-25% of patients being operable at diagnosis [1] - Despite radical surgical treatment, 30-55% of patients may experience recurrence and death post-surgery [1][4][5] Group 3: Product Information - JS207 is a recombinant humanized dual-specific antibody targeting PD-1 and VEGF, primarily used for treating advanced malignancies [10] - The drug has entered Phase II/III clinical research and is involved in multiple Phase II studies across various cancers, including NSCLC, colorectal cancer, triple-negative breast cancer, and liver cancer [10] - JS207 effectively blocks the binding of PD-1 to PD-L1 and PD-L2, and inhibits VEGF from binding to its receptors, enhancing anti-tumor activity by improving the tumor microenvironment [10][11] Group 4: Company Background - Junshi Biosciences, established in December 2012, focuses on the discovery, development, and commercialization of innovative therapies [12] - The company has developed a diverse pipeline of over 50 innovative drugs across five therapeutic areas, with five products already approved for market [12] - Junshi Biosciences aims to provide world-class, trustworthy innovative drugs to patients, with a global workforce of approximately 2,500 employees [12]

Core Viewpoint - Junshi Biosciences (君实生物) announced that its product JS207, a recombinant humanized anti-PD-1 and VEGF bispecific antibody, has received FDA approval for a clinical trial in patients with resectable, AGA-negative non-small cell lung cancer [1] Group 1: Product Information - JS207 is a self-developed bispecific antibody targeting PD-1 and VEGFA, primarily used for the treatment of advanced malignancies [1] - The drug binds with high affinity to both PD-1 and VEGFA, effectively blocking the interaction between PD-1 and PD-L1/PD-L2, as well as inhibiting the binding of VEGF to its receptors [1] - JS207 exhibits both immunotherapeutic and anti-angiogenic properties, neutralizing VEGF to inhibit endothelial cell proliferation, improve the tumor microenvironment, and enhance the infiltration of cytotoxic T lymphocytes in the tumor microenvironment, leading to better anti-tumor activity [1] Group 2: Clinical Trial Details - The clinical trial is an open-label, two-arm, randomized, positive-controlled Phase II/III study comparing JS207 to Nivolumab for neoadjuvant treatment [1] - The study focuses on patients with resectable, AGA-negative non-small cell lung cancer [1]

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 ...

Resumption of Trading - Zhiguang Electric plans to issue new shares to purchase all or part of the minority equity of Guangzhou Zhiguang Energy Technology, leading to the resumption of its stock trading [1] Mergers and Acquisitions - Guotou Fengle's acquirer, Guotou Seed Industry, intends to subscribe for no more than 184 million shares at a price of 5.91 yuan per share [2] Share Buybacks and Equity Transfers - Zhijiang Biology plans to repurchase shares worth between 60 million to 120 million yuan [3] - YTO Express, for strategic and financial planning reasons, intends to transfer no more than 2% of its shares through block trading by Hangzhou Haoyue [4] Daily Operations and External Investments - Zhaofeng Co. signed a strategic cooperation framework agreement with NiuNai Robotics, focusing on cognitive and humanoid robot development [5] - Huayu Automotive completed the acquisition of a 49% stake in Shanghai SAIC Qingtao Energy Technology Co., Ltd. [6] - Dingjide's high-end new material project for petrochemical technology, POE industrialization device, has been put into production [7] - Chiplink Integration plans to increase capital by 1.8 billion yuan to ensure the ongoing implementation of its 12-inch integrated circuit analog mixed-signal chip manufacturing project [7] - Shanghai Xiba has obtained the IATF16949 automotive quality management system certification for the design and production of silicon-carbon anode materials for new energy batteries [7] - Zhongtian Technology won multiple marine series projects in deep-sea technology, totaling approximately 1.788 billion yuan [8] - TBEA's subsidiary plans to acquire 74.19% of Shuguang Cable for 946 million yuan, specializing in 1E-level K1 and K3 cables for nuclear power plants [8] - Junshi Biosciences received FDA approval for the clinical trial application of JS207 for neoadjuvant therapy in non-small cell lung cancer patients [9] - Longbai Group's subsidiary intends to acquire assets related to Venator UK's titanium dioxide business [10] - Yunnan Energy Investment is investing 1.872 billion yuan to construct a 350MW compressed air energy storage demonstration project in Kunming Anning [11] Performance Changes - Shijia Photon reported a net profit of 299 million yuan for the first three quarters, a year-on-year increase of 728%, with orders for optical chips and devices increasing [12] - Guangku Technology expects a net profit of 110 million yuan for the first three quarters, a year-on-year increase of 97.00%-117.00%, driven by technological innovation and new product launches [12] - Rongzhi Rixin anticipates a net profit of 26.4 million to 27.4 million yuan for the first three quarters, a year-on-year increase of 871.30%-908.09% [13] - Guangsheng Nonferrous expects a net profit of 100 million to 130 million yuan for the first three quarters, a year-on-year increase of 136.29% to 147.18%, due to rising rare earth market prices [14] - Aobi Zhongguang expects to achieve a net profit of approximately 108 million yuan for the first three quarters, returning to profitability with rapid growth in various business areas [15] - Cangge Mining reported a net profit of 951 million yuan in the third quarter, a year-on-year increase of 66.49% [15]

截至本公告披露日，JS207已获准进入II/III期临床研究阶段，另有多项II 期临床研究正在进行中，在非 小细胞肺癌、结直肠癌、三阴乳腺癌、肝癌等瘤种中开展与化疗、单抗、抗体偶联药物(ADC)等不同药 物的联合探索。 智通财经APP讯，君实生物(01877)发布公告，近日，上海君实生物医药科技股份有限公司(以下简称"公 司")产品重组人源化抗PD-1和VEGF双特异性抗体(代号：JS207)对比纳武利尤单抗用于 II/III 期、可切 除、可改变驱动基因(AGA)阴性非小细胞肺癌患者新辅助治疗的开放标签、双臂、随机、阳性对照II/III 期临床研究(以下简称"本次研究")的临床试验申请获得美国食品药品监督管理局(FDA)批准。 JS207 为公司自主研发的重组人源化抗PD-1和VEGF双特异性抗体，主要用于晚期恶性肿瘤的治疗。 JS207可同时以高亲和力结合于PD-1与VEGFA，有效阻断PD-1与PD-L1和PD-L2的结合，并抑制VEGF与 其受体的结合。JS207 具有免疫治疗药物和抗血管生成药物的疗效特性，通过中和VEGF可抑制血管内 皮细胞增殖，改善肿瘤微环境，增加细胞毒性T淋巴细胞在肿瘤微环境中 ...

Core Viewpoint - The company, Junshi Biosciences, has received FDA approval for its clinical trial application for JS207, a bispecific antibody targeting PD-1 and VEGF, for use in neoadjuvant therapy for AGA-negative non-small cell lung cancer patients in a Phase II/III study [1][2] Group 1: Product Overview - JS207 is a recombinant humanized bispecific antibody designed to target both PD-1 and VEGF, primarily for the treatment of advanced malignancies [1] - The drug effectively blocks the binding of PD-1 to PD-L1 and PD-L2, as well as the binding of VEGF to its receptors, showcasing both immunotherapy and anti-angiogenic properties [1] - By neutralizing VEGF, JS207 can inhibit endothelial cell proliferation, improve the tumor microenvironment, and enhance the infiltration of cytotoxic T lymphocytes, leading to better anti-tumor activity [1] Group 2: Clinical Development - JS207 is designed based on the clinically validated anti-PD-1 drug, Toripalimab, with a Fab structure to maintain high affinity for PD-1 [2] - The VEGF-targeting component of JS207 has binding affinity comparable to Bevacizumab [2] - Non-clinical in vitro studies indicate that the bispecific antibody shows significantly enhanced PD-1 antigen binding and internalization, as well as synergistic activation of immune cells in the tumor microenvironment compared to the combination of PD-1/PD-L1 and VEGF monoclonal antibodies [2] - As of the announcement date, JS207 has been approved to enter Phase II/III clinical research, with multiple ongoing Phase II studies exploring combinations with chemotherapy, monoclonal antibodies, and antibody-drug conjugates (ADCs) across various cancer types including non-small cell lung cancer, colorectal cancer, triple-negative breast cancer, and liver cancer [2]

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 （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批准的公告》，僅供參閱。 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10月16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 ...