智通财经APP获悉，12月12日，复宏汉霖（02696）宣布公司自研创新型抗PD-1单抗H药 汉斯状®（斯 鲁利单抗，欧洲商品名：Hetronifly®）联合含铂化疗新辅助治疗，在手术后辅助治疗，用于PD-L1阳性 的、可手术切除的胃癌患者的上市注册申请（NDA）获国家药品监督管理局（NMPA）受理，并被纳入 优先审评审批程序。 此次被纳入优先审评意味着审评时限将大幅缩短至130个工作日，标志着H药胃癌围手术期治疗适应症 的上市进程全面提速，H药有望成为全球首个获批用于该领域的抗PD-1单抗。复宏汉霖执行董事、首席 执行官朱俊博士表示，此次获受理并被纳入优先审评，标志着H药胃癌围手术期适应症正式进入上 市"快车道"。 据了解，胃癌是全球高发恶性肿瘤，发病率和死亡率均居前列。当前，免疫治疗在晚期胃癌中已取得进 展，但在围手术期（手术前后）的应用仍属空白，中国尚无在该阶段获批的免疫疗法，临床需求迫切， 亟需能有效降低复发、提升治愈率的新方案。 本次上市申请主要基于该项关键性研究ASTRUM-006的积极结果。期中分析结果显示：该研究达到预设 的优效性标准，与安慰剂联合化疗相比，汉斯状®联合化疗显著改善无事件生存期 ...

Core Viewpoint - The enthusiasm for insurance capital to acquire listed companies has surged, reaching 37 instances this year, marking a near 10-year high and the second highest in history, only behind 62 instances in 2015 [1][5]. Group 1: Regulatory Actions - The Hebei Securities Regulatory Bureau issued a warning letter to Great Wall Life Insurance for failing to disclose timely information regarding its acquisition of shares in Xintian Green Energy, violating the Securities Law of the People's Republic of China [3]. - Great Wall Life Insurance increased its stake in Xintian Green Energy to 5.0027% by acquiring 1 million shares, but did not halt trading upon reaching the 5% threshold, which is a regulatory requirement [3][4]. Group 2: Company Performance - Great Wall Life Insurance's insurance business revenue for the first three quarters of 2025 was 21.455 billion yuan, a decrease of 5.92% compared to 22.806 billion yuan in the same period last year [4]. - The net profit for Great Wall Life Insurance in the first three quarters of 2025 was 872 million yuan, down 70.92% from 2.972 billion yuan in the same period of 2024, with a quarterly net loss of 122 million yuan [4]. Group 3: Market Trends - The current year has seen a significant increase in insurance capital acquisitions, with a notable focus on high-quality equity investments, particularly in sectors like banking, public utilities, and environmental protection [7]. - The insurance capital's preference for high ROE and high dividend stocks indicates a strategic shift towards stable investment returns, with various insurance companies participating in the acquisition trend [7][8]. - The asset allocation of insurance funds in stocks and funds has risen to 15.5%, creating more room for acquisitions and signaling a positive outlook for the market [8].

12月12日，复宏汉霖（2696.HK）宣布公司自研创新型抗PD-1单抗H药汉斯状®（斯鲁利单抗，欧洲商 品名：Hetronifly®）联合含铂化疗新辅助治疗，在手术后辅助治疗，用于PD-L1阳性的、可手术切除的 胃癌患者的上市注册申请（NDA）获国家药品监督管理局（NMPA）受理，并被纳入优先审评审批程 序。此次被纳入优先审评意味着审评时限将大幅缩短至130个工作日，标志着H药胃癌围手术期治疗适 应症的上市进程全面提速，H药有望成为全球首个获批用于该领域的抗PD-1单抗。 ...

今日，复宏汉霖（2696.HK）宣布公司自研创新型抗PD-1单抗H药 汉斯状®（斯鲁利单抗，欧洲商品 名：Hetronifly®）联合含铂化疗新辅助治疗，在手术后辅助治疗，用于PD-L1阳性的、可手术切除的胃 癌患者的上市注册申请（NDA）获国家药品监督管理局（NMPA）受理，并被纳入优先审评审批程序。 此次被纳入优先审评意味着审评时限将大幅缩短至130个工作日，标志着H药胃癌围手术期治疗适应症 的上市进程全面提速，H药有望成为全球首个获批用于该领域的抗PD-1单抗。 复宏汉霖执行董事、首席执行官朱俊博士表示"此次获受理并被纳入优先审评，标志着H药胃癌围手术 期适应症正式进入上市'快车道'。作为全球首个在胃癌围手术期以免疫单药取代术后辅助化疗的创新方 案，该疗法将显著改善患者的生活质量与生存获益。期待这一创新治疗策略尽早惠及广大胃癌患者，为 他们带来治愈希望。 此前，H药已被CDE纳入突破性治疗品种名单，是首个在胃癌围手术期治疗领域获此认定的药物。因符 合优先审评范围，CDE同意将其纳入优先审评审批程序。 ...

（n=10）、2.5 mg/kg（n=10）和3 mg/kg（n=10）的HLX43 治疗。其中超过80%的患者CPS≥1。 患者既往接受肿瘤治疗的中位线数为2.0（范围1–4 线）。全部患者接受过铂类药物化疗，60%的患者接 受过靶向治疗，约50%患者接受过免疫治疗，中位随访时间为3.5 个月。 有效性方面，整体ORR 为41.4%，DCR 为82.8%。3 mg/kg 剂量组的ORR和DCR 为70.0%和100%，患者 中位PFS 尚未达到。 机构：天风证券 研究员：杨松/刘一伯 事件 2025 年12 月5 日，复宏汉霖在ESMO Asia 披露其PD-L1 ADC HLX43 用于复发/转移性宫颈癌的II 期临 床研究数据。继非小细胞肺癌、胸腺癌之后，再度印证了HLX43 在实体瘤领域的广谱治疗潜力。横向 对比，HLX43 的有效性领先同适应症已上市/在研药物，安全性良好，再次展现出色的商业化前景。 疗效优势明显，安全性良好可控 本次数据基于一项开放、随机、多中心的II 期临床研究，研究共纳入30例经组织学确诊为复发/晚期宫 颈癌（CC）且既往接受过标准一线治疗失败、不耐受或禁忌的患者。随机分配接受 ...

智通财经APP讯，复宏汉霖(02696)发布公告，近日，公司自主开发的汉斯状 (斯鲁利单抗注射液)(汉斯 状)联合含铂化疗新辅助，在手术后辅助治疗，用于 PD-L1阳性的、可手术切除的胃癌患者的上市注册 申请(NDA)获国家药品监督管理局(NMPA)药品审评中心受理，并已纳入优先审评审批程序，将加速其 上市审评进程。 本次汉斯状新适应症的上市注册申请(NDA)主要基于一项比较汉斯状联合化疗对比安慰剂联合化疗新辅 助/辅助治疗胃癌患者的临床有效性及安全性的随机、双盲、多中心的3期临床研究。研究结果显示，汉 斯状联合化疗对比安慰剂联合化疗可显著延长患者的无事件生存期(EFS)，达到预设的优效性标准，并 体现出较全程化疗更佳的安全性及耐受性。 （原标题：复宏汉霖(02696)：汉斯状®联合化疗用于胃癌新辅助/辅助治疗的上市注册申请获国家药监 局受理，并已纳入优先审评） ...

汉斯状®为公司自主开发的创新型抗PD-1单抗，其于中国境内(不包括中国港澳台地区，下同)已获批上 市的适应症包括联合化疗一线治疗鳞状非小细胞肺癌(sq-NSCLC)、广泛期小细胞肺癌(ES-SCLC)、食管 鳞状细胞癌(ESCC)及非鳞状非小细胞肺癌(nsq-NSCLC)。同时，汉斯状®亦已分别于欧盟、英国、印度 尼西亚、柬埔寨、泰国、马来西亚、新加坡、及印度等国家/地区获批上市，并分别获美国、欧盟、瑞 士及韩国等国家/地区的药品监督管理部门授予孤儿药资格认定。 此外，公司正有序推进汉斯状®及相关联合疗法在全球开展的多项临床试验，广泛覆盖肺癌、食管癌、 头颈鳞癌、结直肠癌和胃癌等适应症。 格隆汇12月12日丨复宏汉霖(02696.HK)宣布，近日，公司自主开发的汉斯状®(斯鲁利单抗注射液)("汉 斯状®")联合含铂化疗新辅助，在手术后辅助治疗，用于PD-L1阳性的、可手术切除的胃癌患者的上市 注册申请(NDA)获国家药品监督管理局(NMPA)药品审评中心受理，并已纳入优先审评审批程序，将加 速其上市审评进程。 本次汉斯状®新适应症的上市注册申请(NDA)主要基于一项比较汉斯状®联合化疗对比安慰剂联合化疗 新辅 ...

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，並明確表示概不就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 Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2696） 自願公告 漢斯狀® （斯魯利單抗注射液）聯合化療用 於胃癌新輔助/輔助治療的上市註冊申請(NDA) 獲國家藥品監督管理局(NMPA)受理，並已納入優先審評 A. 緒言 本公告由上海復宏漢霖生物技術股份有限公司（「本公司」）自願作出，以告知 本公司股東及潛在投資者本公司最新業務更新。 本公司董事會（「董事會」）欣然宣佈，近日，本公司自主開發的漢斯狀® （斯魯 利單抗注射液）（「漢斯狀®」）聯合含鉑化療新輔助，在手術後輔助治療，用於 PD-L1陽性的、可手術切除的胃癌患者的上市註冊申請(NDA)獲國家藥品監 督管理局(NMPA)藥品審評中心受理，並已納入優先審評審批程序，將加速 其上市審評進程。 B. 申報背景及依據 本次漢斯狀®新適應症的上市註冊 ...

Market Performance - The Hong Kong stock market continued to show weakness, with the Hang Seng Index down 0.43% to 25,324.75 points, the Hang Seng Tech Index down 0.68%, and the National Enterprises Index down 0.51% [1] - Major technology stocks exhibited mixed performance, with NetEase and Bilibili down over 1%, Tencent down 1%, while Meituan rose over 1% [1] - Precious metals performed strongly, with silver reaching a historical high and gold-related stocks rising, including Lingbao Gold which increased nearly 10% [1] - Shipping stocks declined, with Pacific Basin Shipping down 9.5% and Orient Overseas International down 5% [1] - The photovoltaic sector also fell, with China Metallurgical Group down 4.3% and other companies like Xinyi Solar and Flat Glass down over 3% [1] Company News - Datang New Energy reported a cumulative power generation of approximately 31.6521 million MWh in the first 11 months, an increase of 10.58% year-on-year [2] - Jiangshan Holdings reported a total solar power generation of approximately 279.78 thousand MWh in the first 11 months, a decrease of 5.61% year-on-year [3] - New City Development reported a cumulative contract sales amount of approximately 17.917 billion yuan in the first 11 months, a decrease of 51.53% year-on-year [4] - Longfor Group achieved a total contract sales amount of 59.39 billion yuan in the first 11 months [5] - CIFI Holdings reported a cumulative contract sales amount of approximately 15.1 billion yuan in the first 11 months [6] Institutional Insights - Dongwu Securities indicated that the Hong Kong stock market is still in a left-side phase, with a rebound needing to wait, but mid-term positioning appears attractive [12] - Huaxia Fund noted that the previous irrational panic in the tech sector has eased, and the future outlook for AI development is pragmatic with clear commercialization paths [12] - China International Capital Corporation highlighted that the recent weakness in the Hong Kong market is due to multiple factors including a declining credit cycle and liquidity pressure [13] - Everbright Securities mentioned that after a rebound in 2025, the current Hang Seng Index P/E ratio is above the past five-year average, indicating overall valuation repair but still within a reasonable range [13]

Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotechnology Co., Ltd. has received approval from the National Medical Products Administration to conduct clinical trials for HLX22 in combination with HLX87 for HER2-positive breast cancer treatment in mainland China [1] Group 1 - The approved clinical trials will focus on the use of HLX22 as a novel targeted monoclonal antibody for first-line treatment and neoadjuvant therapy in HER2-positive breast cancer [1] - HLX87 is an innovative antibody-drug conjugate (ADC) that links a topoisomerase I inhibitor with an anti-HER2 monoclonal antibody through a stable cleavable linker [1]