Core Insights - The company, Junshi Biosciences (复宏汉霖), has announced that its self-developed drug, Hanshu (Sruilumab injection), has met the primary endpoint of event-free survival (EFS) in a Phase 3 clinical trial for gastric cancer, allowing for early submission for market approval [1] Group 1: Clinical Trial Details - The Phase 3 clinical trial is a randomized, double-blind, multi-center study comparing Hanshu combined with chemotherapy against a placebo combined with chemotherapy for early gastric cancer patients [1] - The interim analysis conducted by the Independent Data Monitoring Committee (IDMC) showed significant improvement in EFS for the Hanshu group compared to the placebo group, meeting the predefined superiority criteria [1] Group 2: Efficacy and Safety - The pathological complete response (pCR) rate for the Hanshu group was over three times that of the control group, indicating a substantial reduction in the risk of recurrence for patients [1] - The safety profile of Hanshu was reported to be good, with no new safety signals identified during the trial [1]

Core Viewpoint - The company, Fuhong Hanlin (02696), has announced that its self-developed drug, Hanshu (Sru Li Antibody Injection), has met the primary endpoint of event-free survival (EFS) in a Phase 3 clinical trial for the treatment of early gastric cancer, supporting an early application for market approval [1] Group 1: Clinical Trial Details - The Phase 3 clinical trial is a randomized, double-blind, multi-center study comparing Hanshu combined with chemotherapy against a placebo combined with chemotherapy for early gastric cancer patients [1] - The independent data monitoring committee (IDMC) conducted a pre-specified interim analysis, which showed significant improvement in EFS for the Hanshu combination therapy compared to the placebo group [1] Group 2: Efficacy and Safety Results - The pathological complete response (pCR) rate for the Hanshu group was more than three times that of the control group, indicating a substantial efficacy advantage [1] - The risk of recurrence for patients receiving Hanshu was significantly reduced, and no new safety signals were identified, demonstrating good safety [1]

Core Insights - The company announced that its self-developed drug Hansizhuang® (sulizumab injection) has met the primary endpoint of event-free survival (EFS) in a Phase 3 clinical trial for gastric cancer, allowing for early submission for market approval [1][2] Group 1: Clinical Trial Results - The Phase 3 clinical trial is a randomized, double-blind, multi-center study comparing Hansizhuang® combined with chemotherapy to placebo combined with chemotherapy for early gastric cancer patients [1] - The interim analysis conducted by the Independent Data Monitoring Committee (IDMC) showed significant improvement in EFS for the Hansizhuang® group, achieving pre-set superiority standards [1] - The pathological complete response (pCR) rate for Hansizhuang® was over three times that of the control group, with a significant reduction in recurrence risk and no new safety signals reported [1] Group 2: Product Information and Approvals - Hansizhuang® is an innovative anti-PD-1 monoclonal antibody that has been approved for various indications in mainland China, including first-line treatment for squamous non-small cell lung cancer (sq-NSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsq-NSCLC) [2] - The drug has also received approvals in several countries/regions, including the EU, UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India, and has been granted orphan drug designation in the US, EU, Switzerland, and South Korea [2] - The company is actively advancing multiple clinical trials for Hansizhuang® and related combination therapies across various indications, including lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric 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） C. 關於漢斯狀® 漢斯狀®為本公司自主開發的創新型抗PD-1單抗，其於中國境內（不包括中國 港澳台地區，下同）已獲批上市的適應症包括聯合化療一線治療鱗狀非小細 胞肺癌(sq-NSCLC)，廣泛期小細胞肺癌(ES-SCLC)、食管鱗狀細胞癌(ESCC) 及非鱗狀非小細胞肺癌(nsq-NSCLC)。同時，漢斯狀®亦已分別於歐盟、英 國、印度尼西亞、柬埔寨、泰國、馬來西亞、新加坡、及印度等國家/地區獲 批上市，並分別獲美國、歐盟、瑞士及韓國等國家/地區的藥品監督管理部門 授予孤兒藥資格認定(Orphan-drug Designation)。 （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3期臨床研究達到主要研究終點 A ...

Core Viewpoint - The Hong Kong biopharmaceutical sector experienced a significant decline, with major companies reporting substantial drops in stock prices, indicating a bearish trend in the market [1]. Group 1: Stock Performance - Innovent Biologics (099660) saw a decline of 11.54%, with a latest price of 16.640 and a market capitalization of 293.36 billion, despite a year-to-date increase of 171.90% [2]. - Rongchang Biologics (09995) dropped by 9.20%, priced at 108.600, with a total market value of 612.08 billion, and a remarkable year-to-date increase of 654.17% [2]. - Kelun-Biotech (06990) fell by 7.71%, with a latest price of 533.000 and a market cap of 1,242.88 billion, while still showing a year-to-date increase of 226.39% [2]. - Tigermed (03347) decreased by 6.86%, priced at 43.960, with a market capitalization of 378.51 billion and a year-to-date increase of 44.25% [2]. - WuXi AppTec (02268) experienced a decline of 6.22%, with a latest price of 77.650 and a market cap of 954.09 billion, maintaining a year-to-date increase of 153.34% [2]. - CanSino Biologics (09926) dropped by 5.15%, priced at 134.500, with a market capitalization of 1,238.94 billion, and a year-to-date increase of 121.58% [2]. - Other companies like Junshi Biosciences (01877) and BeiGene (06160) also reported declines, with respective decreases of 3.16% and 2.48% [2].

Core Insights - The Chinese immune checkpoint inhibitor industry is rapidly developing, with a projected market size of approximately 52.734 billion yuan in 2024, representing a year-on-year growth of 44.14% [1][4][8] - The primary driver of this growth is the innovative therapeutic mechanism of immune checkpoint inhibitors, which reactivate the immune system to identify and attack tumor cells, providing revolutionary treatment options for cancer patients with limited traditional therapies [1][4] Industry Overview - Immune checkpoint inhibitors enhance the immune system's ability to attack cancer cells by blocking immune checkpoint proteins, which are used by tumor cells to evade immune responses [2][5] - The industry has evolved through three stages: initiation, rapid development, and mature expansion, with significant policy support and market entry of domestic products since 2018 [3][4] Market Size - The immune checkpoint inhibitor market in China is expected to reach approximately 52.734 billion yuan in 2024, with a significant increase in clinical application driving market demand [1][8] Key Companies - Leading companies in the industry include Junshi Biosciences, Hengrui Medicine, Innovent Biologics, and BeiGene, which collectively hold over half of the market share [8] - Junshi Biosciences' core product, Toripalimab, has been approved for 12 indications and is the first domestic PD-1 inhibitor to receive FDA approval for kidney cancer treatment [9] - Akeso's dual antibody technology has led to significant advancements, with its PD-1/CTLA-4 dual antibody achieving notable efficacy in cervical cancer [11] Industry Development Trends 1. Continuous technological innovation is driving breakthroughs in precision treatment and combination therapies, with dual antibodies and ADCs becoming more prominent [12] 2. Market expansion and the shift of indications towards early-stage treatments are accelerating internationalization, with several domestic products gaining traction in overseas markets [13] 3. Policy and regulatory developments are promoting industry standardization, with support for new biological agents and reforms in medical insurance payment methods [13]

I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | H | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02696 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 163,428,541 | RMB | | 1 RMB | | 163,428,541 | | 增加 / 減少 (-) | | | | | | RMB | | | | 本月底結存 | | | 163,428,541 | RMB | | 1 RMB | | 163,428,541 | 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年9月30日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 上海復宏漢霖生物技術股份有限公司 呈交日期: 2025年10月8日 | 2. 股份分類 | 普通股 | 股份類別 | 其他類別 ( ...

公开资料显示，2024年11月，复宏汉霖与沙特阿拉伯SVax公司达成战略合作。双方将在沙特阿拉伯分 别设立商业化和生产合资公司，并在MENAT地区就复宏汉霖的一系列产品，包括阿达木单抗汉达远 (HLX03)、贝伐珠单抗汉贝泰(HLX04)，进行合作开发，开展本地注册、生产及商业化。另外，此次合 作框架中的首批项目亦包括共同投资开发复宏汉霖自研的帕博利珠单抗生物类似药HLX17，共同推动 该产品的全球注册上市。 消息面上，复星医药中东办公室及合资公司Fosunhenlius Middle East United Company在沙特吉达正式揭 牌，标志着其在中东地区的本土化运营迈出关键一步。该合资公司由复星医药旗下复宏汉霖与沙特领先 药企SVax共同组建，将整合全球研发资源与本地化优势，为中东、北非及土耳其地区患者提供可负担 的高品质生物药。 复宏汉霖(02696)现涨超10%，截至发稿，涨9.33%，报77.95港元，成交额8233.55万港元。 ...

公开资料显示，2024年11月，复宏汉霖与沙特阿拉伯SVax公司达成战略合作。双方将在沙特阿拉伯分 别设立商业化和生产合资公司，并在MENAT地区就复宏汉霖的一系列产品，包括阿达木单抗汉达远 （HLX03）、贝伐珠单抗汉贝泰（HLX04），进行合作开发，开展本地注册、生产及商业化。另外， 此次合作框架中的首批项目亦包括共同投资开发复宏汉霖自研的帕博利珠单抗生物类似药HLX17，共 同推动该产品的全球注册上市。 消息面上，复星医药中东办公室及合资公司Fosunhenlius Middle East United Company在沙特吉达正式揭 牌，标志着其在中东地区的本土化运营迈出关键一步。该合资公司由复星医药旗下复宏汉霖与沙特领先 药企SVax共同组建，将整合全球研发资源与本地化优势，为中东、北非及土耳其地区患者提供可负担 的高品质生物药。 智通财经APP获悉，复宏汉霖(02696)现涨超10%，截至发稿，涨9.33%，报77.95港元，成交额8233.55万 港元。 ...

Core Viewpoint - The company announced the approval of a clinical trial application for HLX43 in combination with HLX07 for the treatment of advanced/metastatic solid tumors by the National Medical Products Administration (NMPA) [1] Group 1: Product Development - HLX43 is a targeted PD-L1 antibody-drug conjugate (ADC) developed by the company, utilizing a novel DNA topoisomerase I inhibitor small molecule toxin linked to a self-developed PD-L1 targeting antibody [1] - HLX07 is an innovative biological drug developed by the company targeting the EGFR pathway, intended for the treatment of advanced solid tumors [1] Group 2: Clinical Trials - The 1b/2 phase clinical trial results for HLX07 in combination with chemotherapy for advanced solid tumors showed good safety and tolerability [1] - Multiple phase 2 clinical studies for HLX07 are currently underway in China, including studies for HLX07 as a monotherapy for advanced cutaneous squamous cell carcinoma (CSCC) and in combination with Hanshu® for advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) [1]