Core Viewpoint - The company's performance in the first three quarters of 2025 aligns with expectations, showing significant revenue growth and reduced net loss compared to the previous year [1][2]. Financial Performance - Revenue for 1-3Q25 reached 1.806 billion yuan, representing a year-on-year increase of 42.1% [1]. - The net profit attributable to the parent company was -596 million yuan, reflecting a year-on-year reduction in loss of 35.7% [1]. Development Trends - The core product, Tuoyi, continues to see strong sales growth, with domestic market revenue of 1.495 billion yuan in 1-3Q25, up approximately 40% year-on-year [1]. - Tuoyi has received approval for 12 indications in China, with a new indication for HER2-expressing urothelial carcinoma under review by NMPA [1]. - Tuoyi has been approved in 40 countries and regions globally, including Hong Kong, the US, the EU, India, and the UK, with expectations for continued revenue contribution as more indications are approved [1]. Clinical Research and Innovation - The FDA has approved the initiation of clinical research for JS207, a PD-1/VEGF dual-target drug, marking a significant step in its development for operable patients [1]. - The company showcased over 20 research studies at the 2025 ESMO conference, with two studies selected for oral presentations, indicating strong engagement in international academic forums [2]. - Upcoming data updates for JS107 and JS207 at the 2025 ESMO Asia conference highlight the company's commitment to advancing cancer immunotherapy [2]. Profit Forecast and Valuation - The company maintains its net profit forecasts for 2025 and 2026 at -917 million yuan and -315 million yuan, respectively [2]. - The company retains an "outperform" rating based on DCF valuation, with a target price of 36.98 HKD, indicating a potential upside of 47.6% from the current stock price [2].

Core Insights - Junshi Biosciences (688180.SH/1877.HK) reported a continuous increase in commercial revenue and accelerated R&D of differentiated innovative pipelines, showcasing improved sustainable operational capabilities [1][2]. Financial Performance - For the first three quarters, Junshi Biosciences achieved operating revenue of 1.806 billion yuan, a year-on-year increase of 42.06%, while narrowing its net loss to 596 million yuan, a reduction of 35.72% [1]. - In Q3 alone, the company recorded operating revenue of 637 million yuan, reflecting a year-on-year growth of 31.40% [2]. Product Performance - The core product, Tuoyi® (Tremelimumab), generated sales of 1.495 billion yuan in the first three quarters, marking a 40% year-on-year increase [2]. - Tuoyi® has seen six consecutive quarters of sequential growth since 2024, driven by enhanced sales efficiency and the inclusion of more indications in medical insurance [2]. Global Expansion - As of the end of Q3, Tuoyi® has been approved for marketing in over 40 countries and regions across four continents, including major markets like the U.S. and EU, with ongoing expansion into emerging regions [2][6]. - The global commercialization network has been established through partnerships with companies like Coherus and Dr. Reddy's, covering over 80 countries [2][6]. R&D and Pipeline Development - Junshi Biosciences is focusing on next-generation therapies, with high-potential pipelines such as JS207 (PD-1/VEGF), JS212 (HER3/EGFR dual antibody ADC), and JS015 (DKK1 monoclonal antibody) advancing rapidly [2][8]. - The company has developed over 50 drug candidates, including four commercialized products and nearly 30 in clinical stages, indicating strong product iteration capabilities [8]. Clinical Achievements - At the recent ESMO conference, Tuoyi® was highlighted for its combination therapy with ADC drug Vadisizumab, achieving significant clinical results, including an overall survival extension to 31.5 months compared to traditional chemotherapy [5][6]. - The company has also received positive results from its ongoing studies, including the registration study for JS005 (anti-IL-17A monoclonal antibody) in treating moderate to severe plaque psoriasis, which is expected to lead to a market application [11]. Strategic Initiatives - In September 2025, Junshi Biosciences launched an equity incentive plan with performance targets, reflecting strong confidence in future performance [3]. - The company is actively exploring combination therapies for its products, enhancing its competitive edge in the oncology market [9][10].

Core Viewpoint - Junshi Biosciences (01877) has received FDA approval for its clinical trial application for JS207, a dual-specific antibody targeting PD-1 and VEGF, aimed at treating non-small cell lung cancer patients [1][2]. Group 1 - Junshi Biosciences' stock opened nearly 5% higher and is currently trading at 28.04 HKD with a transaction volume of 6.41 million HKD [1]. - The clinical trial for JS207 is a Phase II/III study comparing it to Nivolumab in patients with resectable, AGA-negative non-small cell lung cancer [1]. - JS207 is a recombinant humanized dual-specific antibody that binds with high affinity to both PD-1 and VEGFA, effectively blocking their interactions and exhibiting properties of both immunotherapy and anti-angiogenic drugs [1]. Group 2 - As of the announcement date, JS207 has been approved to enter Phase II/III clinical research, with additional Phase II studies ongoing in various cancers including non-small cell lung cancer, colorectal cancer, triple-negative breast cancer, and liver cancer [2]. - The ongoing studies are exploring combinations of JS207 with chemotherapy, monoclonal antibodies, and antibody-drug conjugates (ADCs) [2].

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].

Core Viewpoint - Junshi Biosciences has received FDA approval for its investigational new drug application for JS207, a bispecific antibody targeting PD-1 and VEGF, aimed at treating resectable non-small cell lung cancer (NSCLC) in a phase 2/3 clinical study [1][3][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 [2] - Non-small cell lung cancer (NSCLC) accounts for about 85% of lung cancer cases, with 20%-25% being surgically resectable at diagnosis; however, 30%-55% of these patients experience recurrence post-surgery [2] Company Overview - Junshi Biosciences is an innovation-driven biopharmaceutical company founded in December 2012, focusing on the discovery and commercialization of novel therapies, with over 50 drug candidates in its R&D pipeline [8][9] - The company has five therapeutic focus areas, including cancer, and has received approvals for five products in China and international markets, including toripalimab, China's first domestically produced anti-PD-1 monoclonal antibody [8] Product Details - JS207 is a recombinant humanized anti-PD-1/VEGF bispecific antibody developed by Junshi Biosciences, currently approved for phase 2/3 clinical studies and being explored in various cancers [5][6] - The drug can bind to PD-1 and VEGFA, blocking their interactions and improving the tumor microenvironment, which enhances anti-tumor activity [6][7] Clinical Study Insights - The phase 2/3 clinical study is an open-label, two-arm, randomized, active-controlled trial comparing JS207 to nivolumab for neoadjuvant treatment in patients with stage II/III, resectable, AGA-negative NSCLC [3][4] - Professor Yilong WU from Guangdong Provincial People's Hospital will lead the study as the principal investigator [3]

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 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]

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 - 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]