Shanghai Henlius(02696)

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拟被复星医药超5亿增持的复宏汉霖,想在海外市场大展拳脚
Di Yi Cai Jing· 2025-04-21 14:41
由于复星医药公司执行董事关晓晖女士兼任无锡通善间接控股股东HermedCapital的董事,本次交易也 构成关联交易。 2024年6月24日,复星医药抛出了一则关于拟以不超过约54.07亿港元私有化复宏汉霖计划。不过,在今 年1月复宏汉霖股票大会投票中,该计划未能获得通过,导致私有化方案搁浅。 今年以来,复宏汉霖二级市场上的股价涨幅超过40%,股价表现抢眼背后,也跟该公司业绩连续实现盈 利有关。 2024年,复宏汉霖实现营业收入约57.24亿元,净利润约8.21亿元,已连续两年通过产品销售实现盈利。 在国内市场竞争激烈的背景下,拓展海外市场是很多创新药企追逐的梦想,复宏汉霖正试图在海外市场 大展拳脚。 复星医药持有复宏汉霖的股权比例将增至63.43%。 复星医药(600196.SH、02196.HK)私有化复宏汉霖(02696.HK)计划没有成行后,拟改为增持后者股 份。 4月21日晚间,复星医药发布公告称,基于对复宏汉霖发展的信心及价值的认可,2025年4月11日至4月 17日期间,控股子公司复星医药产业与上海善梧、无锡通善、舟山果运及Henlink分别达成转让协议, 拟以港币24.60元/股的价格受让该等 ...
复宏汉霖全球化:4年内,在美获批至少8款产品
2 1 Shi Ji Jing Ji Bao Dao· 2025-04-21 11:10
记者/ 韩璐 编辑/ 谭璐 "至今,我们已经为全球75万名患者提供治疗方案和医疗支持。" 近日,复宏汉霖举办2025全球研发日(R&D Day)活动,复宏汉霖执行董事兼首席执行官朱俊打趣 道,之前做医生的时候,一年只能看1000个病人,要活到750岁,才能看75万个患者。 "一位患者的年治疗费用最少3万,累计销售额超过200亿元。"朱俊表示。 2024年,已上市的6款产品,合计为复宏汉霖带来近50亿元销售收入,带动公司营收57.244亿元,利润 8.205亿元,同比增长超过五成。 接下来,复宏汉霖将用更多创新靶点与全球化,创造更大的临床价值。 自有章法 "我们的全球化自有章法。"朱俊介绍,公司针对美国、欧盟、日本、东南亚、中东、拉美六大市场的不 同特点,稳步推进。 目前,复宏汉霖在日本招募资深临床团队,深入了解其医疗需求和临床实践特点,力求在汉斯状结直肠 癌数据出炉后,迅速高效地将产品推向市场。 而东南亚、中东和拉美市场,蕴含着巨大的发展潜力,普遍存在"缺医少药"的问题。 "哪里有市场、哪里有病人、哪里有需求,我们就去哪里。"朱俊表示。 创新为底 美国市场是全球生物医药的高地,竞争异常激烈。复宏汉霖选择自主运 ...
复宏汉霖朱俊:公司将持续深耕抗体药物研发 加速前沿领域创新
Zheng Quan Shi Bao Wang· 2025-04-18 13:15
Core Insights - Fuhong Hanlin is focusing on innovative R&D to strengthen its competitive advantage, with a commitment to patient-centered principles [1] - The company is advancing key innovative products such as HLX22 and HLX43, which are expected to revolutionize treatment for lung cancer and gastrointestinal tumors [1][2] - Fuhong Hanlin is expanding its international strategy, particularly targeting the Japanese market for its core pipelines [3] Group 1: R&D and Product Development - The company is developing several core innovative products, including HLX22, HLX43, and the PD-L1 ADC product, which is designed for targeted cancer therapy [1][2] - Fuhong Hanlin has established three core technology platforms: HinovaTCE, HanjugatorTM, and HAI Club, which enhance its R&D capabilities [2] - The company’s products cover various therapeutic areas, including oncology and autoimmune diseases, with several already approved in multiple regions [2] Group 2: International Expansion Strategy - Fuhong Hanlin is implementing an internationalization strategy with a focus on the Japanese market, leveraging its differentiated advantages in gastric and lung cancer treatments [3] - The company has initiated clinical trials in Japan to support its product development for specific indications [3] - The expansion strategy also includes deepening its presence in the European and Southeast Asian markets [3]
复宏汉霖国际化2.0策略:以核心管线差异化优势切入,突破口在日本市场
IPO早知道· 2025-04-18 03:12
持续推进区域化临床设计,例如汉斯状在美国和日本分别开展专门的桥接试验。 本文为IPO早知道原创 作者| 罗宾 微信公众号|ipozaozhidao 据 IPO早知道消息, 4月15日, 在 复宏汉霖举办 的 2025年"聚·创"全球研发日(R&D Day)活动 中,公司 管理层与来自业界的顶级专家学者、创新研发负责人 就 创新研发领域的最新进展、 国际 化等 未来战略规划以及前沿 领域布局等进行了深入探讨。 复宏汉霖执行董事、首席执行官朱俊博士表示: "复宏汉霖始终践行'以患者为中心'的核心理念,以 创新研发持续强化差异化竞争优势。公司持续推进H药 汉斯状、抗HER2单抗HLX22、PD-L1 ADC HLX43等核心创新产品的开发进程,有望革新肺癌和消化道肿瘤治疗格局。国际化布局方面,复宏 汉霖聚焦美国、欧盟、日本等关键市场,通过全产业链资源整合与国际合作深化,实现从产品出海到 全球价值链构建的战略跃升。 " 创新 HER2单抗及PD-L1 ADC的突破 在复宏汉霖的创新管线布局中, HLX22、HLX43等产品已进入临床后期阶段, 并已展现出 突破性 优势。 HLX43进入 II 期临床, HLX22联用 ...
复宏汉霖(02696) - 自愿公告 - HLX22(重组人源化抗HER2单克隆抗体注射液)联合德曲...
2025-04-17 09:35
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 ...
复宏汉霖2025研发日重磅解码:AI 赋能创新药矩阵,全球化布局加速突破
Jin Rong Jie· 2025-04-17 08:51
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]
复宏汉霖(02696)CEO朱俊:挖掘出创新药“未被满足的需求”,经济效益将自显
智通财经网· 2025-04-17 02:20
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]
复宏汉霖(02696) - 股东周年大会通告
2025-04-15 08:46
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 ...
复宏汉霖(02696) - 股东周年大会;续聘审计机构;授予发行股份及回购H股之一般性授权;建议修订...
2025-04-15 08:42
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 ...
复宏汉霖(02696) - 2024 - 年度财报
2025-04-15 08:38
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].