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） 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，一項HLX22（重組人源化抗 HER2單克隆抗體注射液）（「HLX22」）聯合德曲妥珠單抗治療HER2低表達 HR陽性的局部晚期或轉移性乳腺癌的2期臨床研究於中國境內（不包括港澳 台地區，下同）完成首例患者給藥。 B. 臨床試驗設計及目的 本研究是一項多中心的2期臨床研究，旨在評估HLX22聯合德曲妥珠單抗治 療經標準治療後疾病進展或不可耐受毒性反應的，HER2低表達HR陽性的 局部晚期或轉移性乳腺癌患者的療效和安全性。符合條件的受試者將接受 HLX22（15mg/kg，靜脈注 ...

Core Insights - The event "聚.创" Global R&D Day held by Fuhong Hanlin showcased the company's strategic vision and technological breakthroughs in innovative drug development, attracting significant industry attention [1] - Fuhong Hanlin emphasizes a patient-centered approach, having provided treatment solutions to at least 750,000 patients, resulting in cumulative sales exceeding 20 billion [2] - The company has six products on the market, with five developed entirely in-house, and reported a revenue of 5.72 billion last year, investing one-third in R&D while achieving profitability for two consecutive years [2] Internationalization Strategy - Fuhong Hanlin focuses on key markets such as the US, EU, and Japan, aiming to enhance its global value chain through resource integration and international collaboration [3] - The company plans to accelerate the development of core innovative products like H药汉斯状, anti-HER2 monoclonal antibody HLX22, and PD-L1 ADC HLX43, promoting affordable high-quality biopharmaceuticals globally [3] R&D Innovations - The company has established three core technology platforms: Hinova TCE, HanjugatorTM, and HAI Club, which facilitate collaborative R&D and enhance the development of differentiated innovative molecules [3] - HLX43, a PD-L1 ADC product, is in late clinical stages and shows promising potential for treating solid tumors, with ongoing clinical studies [4] AI-Driven Development - Fuhong Hanlin has made significant advancements in AI-assisted drug development, reducing the molecular design cycle from 18 months to 5 months, thus enhancing efficiency [5] - The company aims to leverage its AI platform to support the development of innovative drugs and biosimilars, particularly in the subcutaneous administration market [5] Global Collaboration - Fuhong Hanlin is building an international cooperation ecosystem to enhance its product development and market access, emphasizing trust, efficiency, and innovation in partnerships [6][7] - The company has established a comprehensive biopharmaceutical platform covering the entire value chain, which has garnered confidence from its partners [7] Overcoming Development Challenges - The company addresses the translational gap in biopharmaceutical R&D, focusing on patient-centered innovations to ensure clinical benefits [8] - Discussions at the event highlighted the importance of collaboration and breaking down barriers in the industry to achieve effective transitions from discovery to delivery [8] Future Outlook - Fuhong Hanlin aims to continue driving innovation and globalization, contributing to the global biopharmaceutical landscape and enhancing human health with Chinese wisdom [9]

Core Viewpoint - The financial data and commercialization results of biotech companies have become key indicators for secondary investors following rapid expansion and the bursting of the innovation drug market bubble in the biopharmaceutical sector [1] Group 1: Company Performance - Companies such as BeiGene and Kelun-Biotech have seen their market values double due to strong pipeline progress [1] - The company Fuhong Hanlin has experienced a stock price increase of over 90% since February, with a trading volume exceeding 2.4 billion HKD and a turnover rate of 52% [1] - In 2024, Fuhong Hanlin achieved a revenue of 5.724 billion CNY, a year-on-year increase of 6.1%, and a net profit of 820.5 million CNY, up 50.3% [7] - The cumulative sales of Fuhong Hanlin have surpassed 20 billion CNY [3] Group 2: Research and Development - Fuhong Hanlin's R&D expenditure reached 1.8405 billion CNY in 2024, a year-on-year increase of 28.4%, serving as a driving force for innovation growth [3] - The company has made significant progress in its pipeline, with multiple products receiving regulatory approvals, including HLX11 and HLX22 [3][4] - The company has committed one-third of its revenue to R&D, resulting in six marketed products and substantial benefits for 750,000 patients [5] Group 3: International Expansion - Fuhong Hanlin has accelerated its internationalization process, achieving a closed-loop in its global strategy with products launched in various countries [8] - The company has established a partnership network with over 100 global markets, enhancing its treatment offerings in breast cancer and other areas [9] - The company has built a commercial production capacity of 48,000 liters, ensuring stable supply across multiple regions [9] Group 4: Market Outlook - Analysts from Tianfeng and CMB Securities have given Fuhong Hanlin a "buy" rating, citing its continuous investment in biopharmaceutical innovation and global expansion as key growth drivers [9] - The company is expected to maintain steady growth as core products continue to gain market traction and new products are launched [9]

股東周年大會通告 茲通告上海復宏漢霖生物技術股份有限公司（「本公司」）謹訂於2025年5月8日 （星期四）上午10時正假座中國上海市徐匯區宜州路188號B8幢10樓會議室舉行股東周 年大會（「股東周年大會」），以考慮及酌情通過以下決議案為普通決議案及特別決議案 （除非另有說明，否則本通告及下列決議案所用詞彙與本公司日期為2025年4月15日之 通函所定義者具相同涵義）： 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通告的內容概不負 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通告全部或任何 部份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） 普通決議案 – 1 – 1. 審議及批准本公司及其附屬公司（「本集團」）2024年年度報告。 2. 審議及批准本公司董事會（「董事會」）2024年度工作報告。 3. 審議及批准本公司監事會2024年度工作報告。 4. 審議及批准本集團2024年度財務決算報告。 5. 審議及批准 ...

此乃要件 請即處理 閣下如對本通函任何方面或應採取之行動有任何疑問，應諮詢股票經紀或其他註冊證券商、銀行經理、律師、專業會 計師或其他專業顧問。 閣下如已出售或轉讓名下所有上海復宏漢霖生物技術股份有限公司之股份，應立即將本通函連同隨附之代表委任表格 送交買主或承讓人，或經手買賣或轉讓之銀行、股票經紀或其他代理商，以便轉交買主或承讓人。 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通函之內容概不負責，對其準確性或完整性亦不發表任何 聲明，並表明概不就因本通函全部或任何部分內容而產生或因倚賴該等內容而引致之任何損失承擔任何責任。 （股份代號：2696） (1) 2024年年度報告 (2) 2024年度董事會工作報告 (3) 2024年度監事會工作報告 (4) 2024年度財務決算報告 (5) 2024年度利潤分配預案 (6) 2025年度財務預算方案 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） (7) 續聘審計機構 (8) 2024年專職執行董事的報酬 (9) 2025年專職執行董事的報酬方案 (10) 授予發 ...

Financial Performance - The company achieved continuous profitability in 2024, demonstrating strong market performance and operational efficiency[12]. - In 2024, the company achieved a total revenue of RMB 5.724 billion, an increase of approximately RMB 329.5 million or 6.1% compared to 2023[22]. - Net profit for 2024 reached RMB 820.5 million, representing a year-on-year growth of 50.3% and a net profit margin of 14.3%, up 41.6% from the previous year[22]. - The company's total assets as of December 31, 2024, were RMB 10.598 billion, while total liabilities were RMB 7.584 billion, resulting in net assets of RMB 3.014 billion[25]. - The group's gross profit for the 12 months ending December 31, 2024, was approximately RMB 41,847 million, an increase of approximately RMB 2,659 million compared to the previous year, mainly due to the continued sales growth of key commercialized products[110]. - The group's net profit increased from approximately RMB 5,460 million for the year ending December 31, 2023, to approximately RMB 8,205 million for the year ending December 31, 2024, an increase of approximately RMB 2,745 million[119]. Product Development and Innovation - The company focuses on innovative drug development, emphasizing the integration of source innovation and clinical value to accelerate the provision of breakthrough clinical solutions[12]. - The innovative pipeline includes approximately 50 molecules, focusing on monoclonal antibodies, ADCs, and fusion proteins, with ongoing clinical trials for various cancer treatments[18]. - The company is actively developing innovative monoclonal antibodies and other therapies, with several products in various stages of clinical trials[52]. - The company has approximately 50 molecules and 14 research and development platforms, covering a wide range of drug forms including monoclonal antibodies, multi-antibodies, antibody-drug conjugates (ADCs), fusion proteins, and small molecules[45]. - The company is committed to addressing unmet clinical needs through differentiated strategies and advanced technology in drug research and development[12]. Market Expansion and Partnerships - The company aims to strengthen its international supply chain and localized operational capabilities to accelerate global market expansion[13]. - The company plans to deepen global partnerships and expand its global footprint through diverse strategic collaborations[13]. - The company is actively expanding its international market presence through partnerships with Accord, Eurofarma, KGBio, and Organon[19]. - The company has successfully registered Hanquyou® in multiple countries, including Brazil, the Philippines, and Uzbekistan, expanding its international footprint[57]. - The company has entered into multiple international collaborations to advance overseas commercialization, including agreements with Getz Pharma for commercialization in Pakistan and Abbott for five products across 69 countries in Asia, Latin America, and the Middle East[70]. Regulatory Approvals and Clinical Trials - The IND for HLX22, a recombinant humanized anti-HER2 monoclonal antibody, was approved in December 2024 for a Phase 2 trial in combination with trastuzumab and chemotherapy for HER2-expressing solid tumors[41]. - The IND for HLX14, a biosimilar to denosumab, achieved primary endpoints in a Phase 3 clinical trial for osteoporosis in postmenopausal women[39]. - The IND application for HLX43 (targeting PD-L1 antibody - novel DNA topoisomerase I inhibitor conjugate) was approved in December 2024, with the first patient dosing in a phase 2 clinical study for recurrent/metastatic esophageal squamous cell carcinoma completed in January 2025[79]. - The company has submitted 17 clinical trial applications (IND) and 25 new drug applications (NDA) during the reporting period, receiving approvals for 12 INDs and 17 NDAs across various regions including China, the US, and the EU[74]. - The international multicenter phase 3 clinical study of HLX11 (recombinant anti-HER2 domain II humanized monoclonal antibody injection) for HER2-positive and HR-negative early or locally advanced breast cancer achieved its primary endpoint in September 2024[78]. Operational Efficiency and Production Capacity - The company emphasizes the importance of technological innovation and process optimization to improve production efficiency while adhering to international quality management standards[12]. - The company has a total commercial production capacity of 48,000 liters, with successful initial commercial shipments of products like Hansizhuang® and Hanquyou® to multiple overseas regions during the reporting period[46]. - The company has established a biopharmaceutical production base in Shanghai, which has received GMP certification from China, the EU, Brazil, and Indonesia, enabling regular supply to global markets[92]. - The company is investing up to RMB 2.54 billion in the construction of a new production base in Songjiang, which is expected to enhance its overall production capacity for monoclonal antibody biopharmaceuticals[132]. - The company plans to complete the overall acceptance of the first phase of the Songjiang Base II project by 2025, which will enhance its global supply capabilities[100]. Corporate Governance and Financial Management - The company is committed to ESG management strategies, enhancing governance and sustainability practices[90]. - The company has established a profit distribution policy prioritizing cash dividends, with the option to use stock dividends if necessary to align with capital expansion and performance growth[147]. - The company has no distributable reserves as of December 31, 2024[158]. - The company has not engaged in any significant transactions or arrangements during the reporting period that would involve directors or supervisors having a substantial interest[168]. - The company has established a financial services agreement with Fosun Finance, with a maximum daily deposit amount not exceeding RMB 200 million for the years ending December 31, 2024, and December 31, 2025[189].

1 2024年環境、社會及管治報告 | 目錄 關於本報告 管理層致辭 | | 3 人才 4 員工權益與僱傭 | | | --- | --- | --- | --- | | | | 2024 ESG 亮點績效 5 員工培育與成長 | | | | | | 走進復宏漢霖 7 員工回饋與關愛 | | | 關於我們 | 7 職業健康與安全 | | | 企業管治 | 42 | | --- | --- | | 企業治理與管理 | 43 | | 落實責任經營 | 45 | | 附錄一：關鍵績效表 | 48 | | 附錄二：GRI 內容索引 | 54 | | 附錄三：聯交所指引 | 58 | | 附錄四：意見反饋 | 62 | | 鑑證聲明 | 63 | 2 2024年環境、社會及管治報告 ESG 管理策略 利益相關方溝通 重大性議題矩陣 產品 產品管線 產品普惠 創新研發 品質引領 環境 應對氣候變化 夯實環境管理 社會 供應鏈管理與發展 共建溫暖家園 行業合作與發展 8 9 10 11 12 13 16 17 21 22 23 25 28 29 30 32 37 38 41 41 關於本報告 管理層致辭 2024 ESG ...

智通财经APP获悉，复宏汉霖(02696)涨超4%，截至发稿，涨4.45%，报31.7港元，成交额2551.34万港 元。 据介绍，H药汉斯状是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，已在中国、欧洲和东南亚等30 多个国家和地区获批上市。截至目前，H药已获批用于治疗鳞状非小细胞肺癌(sqNSCLC)、广泛期小细 胞肺癌(ES-SCLC)、食管鳞状细胞癌(ESCC)和非鳞状非小细胞肺癌(nsNSCLC)。聚焦肺癌和消化道肿瘤 等全球高发癌种，复宏汉霖在全球同步开展10余项以H药为核心的免疫联合疗法临床研究，于中国、美 国、日本、土耳其、波兰、格鲁吉亚等国家和地区累计入组逾4900人。 消息面上，据市场消息报道，由国际胃癌协会(International Gastric Cancer Association,IGCA)主办的第16 届国际胃癌大会(International Gastric Cancer Congress, IGCC 2025)将于2025年5月7日-10日在荷兰阿姆斯 特丹召开。此届大会上，复宏汉霖自主研发的创新型单抗H药汉斯状(斯鲁利单抗，欧洲商品名： Hetronifly)两项胃癌领 ...

智通财经APP讯，复宏汉霖(02696)发布公告，近日，注射用HLX43(靶向PD-L1抗体-新型DNA拓扑异构 酶I抑制剂偶联药物)(HLX43)联合汉斯状®(斯鲁利单抗注射液)(汉斯状)治疗晚期/转移性实体瘤患者的 1b/2期临床研究于中国境内(不包括港澳台地区，下同)完成首例患者给药。 本研究为一项旨在评估HLX43联合汉斯状治疗晚期/转移性实体瘤患者的安全性、耐受性和有效性的 1b/2期临床研究。研究分为1b期剂量递增和2期剂量拓展两个阶段。第一阶段为开放标签研究，合格的 受试者将接受不同剂量的 HLX43联合固定剂量的汉斯状静脉输注给药，每3周一次(Q3W)。第二阶段为 多中心、随机、开放标签的对照研究，在第一阶段数据的基础上，评估3个不同剂量的HLX43联合固定 剂量汉斯状在晚期非小细胞肺癌(NSCLC)患者中的安全性和有效性。第一阶段的主要终点为剂量限制性 毒性(DLT)观察期内每个剂量组发生DLT事件的受试者比例和HLX43联合汉斯状用药的最大耐受剂量 (MTD)。第二阶段的主要终点为独立影像评估委员会(IRRC)根据实体瘤疗效评价标准(RECIST)v1.1评估 的客观缓解率(ORR)。 H ...

（股份代號：2696） 自願公告 注射用HLX43（靶向PD-L1抗體－新型DNA 拓撲異構酶I抑制劑偶聯藥物）聯合漢斯狀® （斯魯利單抗注射液） 治療晚期/轉移性實體瘤患者的1b/2期臨床 研究於中國境內完成首例患者給藥 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。 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） HLX43是由本公司利用於2022年11月自蘇州宜聯生物醫藥有限公司許可引進 的新型DNA拓撲異構酶I抑制劑小分子毒素－肽鏈連接子與本公司自主研發 的靶向PD-L1的抗體進行偶聯開發的靶向PD-L1的抗體偶聯藥物(ADC)，擬用 於晚期/轉移性實體瘤的治療。2023年10月，HLX43用於治療晚期/轉移性實 體瘤的1期臨床 ...