Core Viewpoint - Junshi Biosciences has received FDA approval for the IND application of JS207, a bispecific antibody targeting PD-1 and VEGF, for a phase 2/3 clinical study in patients with resectable NSCLC [1][4]. Industry Overview - Lung cancer is the most prevalent and deadly malignant tumor globally, with approximately 2.48 million new cases and 1.82 million deaths reported in 2022. NSCLC accounts for about 85% of lung cancer cases, with 20%-25% being surgically resectable at diagnosis. Despite surgical treatment, 30%-55% of patients experience recurrence and death [2]. Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company founded in December 2012, focusing on the discovery and commercialization of novel therapies. The company has over 50 drug candidates in its R&D pipeline, with five products approved in China and international markets, including toripalimab, China's first domestically produced anti-PD-1 monoclonal antibody [8][9]. Product Details - JS207 is a recombinant humanized anti-PD-1/VEGF bispecific antibody developed by Junshi Biosciences for advanced malignant tumors. It is currently approved for phase 2/3 clinical studies and is being explored in combination with other therapies for various cancers, including NSCLC and triple-negative breast cancer [5][6]. Clinical Study Design - The phase 2/3 clinical study is an open-label, two-arm, randomized, active-controlled trial comparing the efficacy and safety of JS207 to nivolumab for neoadjuvant treatment in stage II/III, resectable, AGA-negative NSCLC. This study is significant as JS207 is the first PD-1/VEGF dual-target drug approved for such a study [3][4]. Mechanism of Action - JS207 binds simultaneously to PD-1 and VEGFA, blocking their interactions and enhancing anti-tumor activity. It combines the effects of immunotherapeutic and anti-angiogenic drugs, improving the tumor microenvironment and increasing cytotoxic T lymphocyte infiltration [6][7].

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]

Core Viewpoint - Junshi Biosciences announced the approval of its clinical trial application for JS207, a humanized anti-PD-1 and VEGF bispecific antibody, by the U.S. FDA for a Phase II/III study in patients with resectable, AGA-negative non-small cell lung cancer [1] Group 1 - The clinical trial is an open-label, two-arm, randomized, positive-controlled study [1] - The study compares JS207 with Nivolumab in the neoadjuvant treatment setting [1] - The focus is on patients with AGA-negative non-small cell lung cancer [1]

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]

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 - 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 ...