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]

Core Viewpoint - The announcement highlights 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 novel antibody-drug conjugate (ADC) targeting PD-L1, developed by the company using a licensed small molecule toxin-peptide linker and its own PD-L1 targeting antibody [1] - HLX07 is an innovative biological drug developed by the company targeting EGFR, intended for the treatment of advanced solid tumors [1] Group 2: Clinical Trials - The 1b/2 phase clinical study of HLX07 in combination with chemotherapy for advanced solid tumors showed good safety and tolerability as of February 2023 [1] - Multiple phase 2 clinical studies of HLX07 are currently underway in China, including trials for advanced cutaneous squamous cell carcinoma (CSCC) and advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) [1]

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 注射用HLX43（靶向PD-L1抗體偶聯藥物） 聯合HLX07（重組抗EGFR人源化單克隆抗體注射液） 用於晚期/轉移性實體瘤治療的1b/2期臨床試驗申請 獲國家藥品監督管理局批准 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」）欣然宣布，近日，注射用HLX43（靶向PD-L1抗體 偶聯藥物）（「HLX43」）聯合HLX07（重組抗EGFR人源化單克隆抗體注射液） （「HLX07」）用於晚期/轉移性實體瘤治療的1b/2期臨床試驗申請獲國家藥品 監督管理局（「NMPA」）批准。 1 B. 關於HLX43及HLX07 HLX43是由本 ...

Core Viewpoint - Shanghai Fosun Pharmaceutical's subsidiary, Fuhong Hanlin, has received approval from the National Medical Products Administration to conduct clinical trials for HLX43 in combination with HLX07 for the treatment of advanced/metastatic solid tumors [1] Group 1: Clinical Trials and Drug Development - The clinical trials will be conducted domestically, focusing on Phase Ib/II studies [1] - HLX43 is a targeted PD-L1 antibody-drug conjugate, while HLX07 is an innovative biopharmaceutical targeting the EGFR [1] - As of September 30, 2025, multiple clinical studies for HLX43 are being conducted globally, and several Phase II clinical studies for HLX07 are underway in China [1] Group 2: Financial Investment and Market Context - Cumulative research and development investment for this treatment regimen has reached approximately 150,000 yuan as of August [1] - There are currently no similar combination therapies approved for market globally [1]

持續創新，卓越運營；以優質生物藥，造福全球病患 願景 專注提供質高價優的生物藥， 成為全球最受信賴的創新生物製藥公司 2025 中期報告 INTERIM REPORT 2025 中期報告 使命 獨立非執行董事 目錄 蘇德揚8 陳力元 宋瑞霖 Yihao Zhang9 趙國屏10 | 公司資料 | 2 | | --- | --- | | 運營摘要 | 4 | | 管理層討論與分析 | 11 | | 獨立審閱報告 | 37 | | 中期簡明綜合損益表 | 38 | | 中期簡明綜合全面收益表 | 39 | | 中期簡明綜合財務狀況表 | 40 | | 中期簡明綜合權益變動表 | 41 | | 中期簡明綜合現金流量表 | 42 | | 中期簡明綜合財務資料附註 | 44 | | 一般資料 | 61 | | 釋義 | 72 | 公司資料 董事 主席及非執行董事 Wenjie Zhang1 執行董事 朱俊 （首席執行官） 2 Wenjie Zhang1 非執行董事 陳啟宇 陳玉卿3 關曉暉4 劉毅5 Xingli Wang 吳以芳6 文德鏞7 監事 審計委員會 馮蓉麗 （主席） 孔德力 劉志勇11 袁曄星12 Wenj ...