Core Insights - The company Fuhong Hanlin has announced the completion of the first patient dosing in the Phase II clinical trial of its innovative anti-HER2 monoclonal antibody HLX22, in combination with Trastuzumab, for the treatment of HER2 low-expressing HR-positive locally advanced or metastatic breast cancer [1] Group 1 - The Phase II clinical study (HLX22-BC201) has been completed for the first patient in China [1] - The treatment area for HLX22 has expanded to include breast cancer, following its application in HER2-positive gastric cancer [1]

Core Insights - The article highlights the growth and global ambitions of Fuhong Hanlin, showcasing its achievements in providing affordable biopharmaceuticals to 750,000 patients globally and generating over 20 billion yuan in sales over the past four years [2] - Fuhong Hanlin is transitioning from a "follower" to a "definer" in the biopharmaceutical industry, with a focus on innovative drugs and breaking the monopoly of multinational pharmaceutical companies [4][5] - The company is leveraging strategic partnerships and advanced technology platforms to enhance its research and development capabilities, aiming to create a comprehensive "R&D-production-commercialization" loop [3][9] Company Growth and Market Strategy - Fuhong Hanlin has successfully launched six drugs, with four approved overseas, and is expanding its market presence in over 50 countries [2] - The company’s revenue from overseas markets is on the rise, supported by its "wall-breaking strategy" in regions like the EU and Japan [2][3] - The PD-1 monoclonal antibody, Hanshuang, has become the first approved treatment for extensive-stage small cell lung cancer globally, showcasing the company's innovative capabilities [4][5] Product Development and Innovation - The company has developed a diverse pipeline of approximately 50 molecules, including monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates (ADCs) [9] - Fuhong Hanlin's HLX22, targeting HER2-positive gastric cancer, demonstrates promising results in clinical trials, indicating its potential as a new first-line treatment option [12] - The company is also advancing its next-generation product, HLX43, a PD-L1 ADC drug, which shows significant efficacy in early trials for pancreatic and colorectal cancers [6] Technological Advancements - Fuhong Hanlin has established three major technology platforms to enhance its drug development process, including the Hinova TCE platform for T cell activation and the Hanjugator™ ADC platform to overcome traditional drug resistance [9][10] - The integration of AI in the drug development process has significantly reduced the research cycle for hyaluronidase from 18 months to 5 months, showcasing the company's commitment to innovation [12] Globalization and Strategic Partnerships - The company is strategically targeting six major global markets, with a focus on the U.S., EU, and Japan, while also establishing local partnerships in Southeast Asia, the Middle East, and Latin America [13][14] - Fuhong Hanlin has formed collaborations with notable entities, including Nobel laureate Carolyn Bertozzi, to develop dual-function antibodies and enhance its ADC product pipeline [14]

Transaction Overview - The company plans to acquire a total of 21,034,313 non-listed shares of Fuhong Hanlin at a price of HKD 24.60 per share, representing approximately 3.87% of the total shares outstanding as of the announcement date [2][7] - The total transaction value amounts to HKD 517,444,099.80, which is equivalent to approximately RMB [2][7] - Following the completion of this acquisition, the company's ownership in Fuhong Hanlin will increase from 59.56% to 63.43% [3][9] Related Party Transactions - The acquisition includes a related party transaction as the company’s executive director, Ms. Guan Xiaohui, is also a director of Wuxi Tongshan, which is a related party [3][9] - The shares acquired from Wuxi Tongshan amount to 4,666,667, constituting part of the related party transaction [3][9] Regulatory Compliance - The acquisition does not constitute a major asset restructuring as defined by the relevant regulations [4][10] - No approval from the board of directors or shareholders is required for this transaction [5][11] Company Background - Fuhong Hanlin, established in February 2010 and listed on the Hong Kong Stock Exchange in September 2019, focuses on the research, production, and sales of monoclonal antibody drugs [12] - As of the announcement date, Fuhong Hanlin has a total of 543,494,853 shares, including 163,428,541 H-shares and 380,066,312 non-listed shares [12] Financial Performance - As of December 31, 2024, Fuhong Hanlin reported total assets of RMB 1,059,752,000, equity attributable to shareholders of RMB 301,362,000, and total liabilities of RMB 758,390,000 [13] - For the year 2024, Fuhong Hanlin achieved revenue of RMB 572,445,000 and a net profit of RMB 82,047,000 [13] Seller Information - Wuxi Tongshan, one of the sellers, was established in May 2016 and has total assets of RMB 9,519,000 as of December 31, 2024 [14] - Other sellers include Shanghai Shanwu, Zhoushan Guoyun, and Henlink, each with varying business focuses and financial standings [15][16][17] Impact on the Company - The acquisition reflects the company's confidence in Fuhong Hanlin's growth and value, enhancing its stake in a key antibody technology platform [19]

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 ...

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 ...

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]

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 ...

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]