Core Viewpoint - Zai Ding Pharmaceutical (09688) announced that its partner Amgen will stop the FORTITUDE-102 clinical trial due to insufficient efficacy based on interim analysis requested by the data monitoring committee [1] Group 1 - The FORTITUDE-102 trial was evaluating the combination of bemarituzumab with chemotherapy and nivolumab for first-line gastric cancer [1] - The announcement was made during Amgen's Q3 2025 earnings call on November 4, 2025 [1]

Core Viewpoint - The company Zai Lab (09688) announced that its partner Amgen will halt the FORTITUDE-102 clinical trial due to insufficient efficacy observed in a preliminary analysis mandated by the data monitoring committee [1] Group 1 - The FORTITUDE-102 trial was assessing the combination of bemarituzumab with chemotherapy and nivolumab for first-line gastric cancer treatment [1] - The announcement was made during Amgen's Q3 2025 earnings call scheduled for November 4, 2025 [1]

Core Viewpoint - The article discusses a significant clinical study on bladder cancer treatment conducted by Chinese researchers, highlighting the promising results of combining two novel drugs, a PD-1 immune drug and an HER2-targeted antibody-drug conjugate, which may redefine first-line treatment standards for advanced bladder cancer [1][6][9]. Group 1: Bladder Cancer Overview - Bladder cancer is the most common type of urinary system tumor, with nearly 100,000 new cases reported annually in China, primarily affecting middle-aged and older men, largely due to smoking [1][2]. - Early detection of bladder cancer leads to high survival rates, but advanced stages are challenging due to drug resistance and recurrence [2]. Group 2: Treatment Landscape - Traditional chemotherapy has been the main treatment for bladder cancer for decades, but it has limited effectiveness, with a median survival of just over one year and significant side effects [3]. - New drug classes, including immune therapies and antibody-drug conjugates (ADCs), have emerged as hopeful alternatives, with several PD-1/PD-L1 immune drugs already approved for bladder cancer [4][5]. Group 3: Clinical Study Insights - The recent study involved 484 patients with HER2-positive advanced urothelial carcinoma, randomly assigned to receive either the new drug combination or traditional chemotherapy [9]. - Results showed that the new drug combination significantly outperformed chemotherapy across various metrics, indicating a potential shift in treatment standards [10][14]. Group 4: Drug Development and Approval - The combination of the PD-1 immune drug Toripalimab and the HER2-targeted ADC Disitamab Vedotin has shown promising results, with the potential for approval in first-line treatment for advanced bladder cancer [17][18]. - The success of this study reflects the rapid advancement of China's domestic drug development capabilities, with increasing recognition in top-tier clinical journals [19][20]. Group 5: Future Directions - The emergence of multiple treatment options for bladder cancer, including various drug combinations, suggests a move away from traditional chemotherapy as the sole first-line treatment [21]. - Future treatment decisions may rely on biomarker expressions, such as HER2 and PD-L1, to optimize patient outcomes [22]. - Ongoing research is expected to explore the durability of treatment responses and the potential for earlier intervention in the treatment process [24].

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 ...

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]

Core Viewpoint - The company announced that its product, JS207, a recombinant humanized anti-PD-1 and VEGF bispecific antibody, has received FDA approval for a clinical trial application to compare it with Nivolumab in a Phase II/III study for neoadjuvant treatment in patients with resectable, genetically altered negative non-small cell lung cancer [1] Group 1 - JS207 is developed by the company and is primarily used for the treatment of advanced malignant tumors [1] - The clinical trial is an open-label, two-arm, randomized, positive-controlled Phase II/III study [1] - The study focuses on patients with resectable, genetically altered negative non-small cell lung cancer [1]

Core Viewpoint - Zai Ding Pharmaceutical (09688) shares rose over 5%, currently up 5.38% at HKD 25.48, with a trading volume of HKD 224 million [1] Group 1: Clinical Research Updates - Recently, Zai Ding Pharmaceutical announced that its partner Amgen has completed the final analysis of the FORTITUDE-101 Phase III clinical study, which evaluates the efficacy of Bemarituzumab combined with chemotherapy (mFOLFOX6) for first-line treatment of gastric cancer [1] - The interim analysis showed significant statistical and clinical improvement in overall survival with the Bemarituzumab combination compared to chemotherapy alone; however, the survival benefit observed in the interim analysis weakened in the final analysis [1] - Amgen stated that the results of both the interim and final analyses will be presented at an upcoming major medical conference [1] Group 2: Future Research Plans - Based on the updated results from the FORTITUDE-101 study, the company plans to wait for the results of the FORTITUDE-102 study, which aims to evaluate Bemarituzumab combined with Nivolumab and chemotherapy for the same patient population, before submitting a registration application [1] - Data from the FORTITUDE-102 study is expected to be released by the end of 2025 or in the first half of 2026 [1]