Shanghai Henlius(02696)
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斥资5.17亿港元增持复宏汉霖,复星医药欲巩固控制权
Huan Qiu Lao Hu Cai Jing· 2025-04-24 05:14
近日,复星医药披露公告称,在2025年4月11日至17日期间,公司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分别签订转让协议,受让卖方合计持有的2103.43万股复宏汉霖非上 市股份,转让价款共计5.17亿港元。 本次增持完成后,集团持有复宏汉霖的股权比例将从59.56%增至63.43%。其中,复星医药产业受让的 无锡通善持有的466.67万股复宏汉霖非上市股份构成关联交易。 这是继私有化复宏汉霖未果后,复星医药再次对其出手。 2024年6月24日,复星医药抛出了一则关于拟以不超过54.07亿港元私有化复宏汉霖计划。彼时复宏汉霖 H股价格为18.84港元/股,私有化溢价达30.57%。不过,在今年1月复宏汉霖股东大会投票中,因独立H 股股东反对票占比超10%,导致私有化方案告终。 资料显示,复星汉霖是复星医药旗下专注于生物制药的重要子公司,公司业务涉及创新生物药,涵盖肿 瘤、自身免疫性疾病等多个领域。 值得一提的是,在增持复宏汉霖的同时,复星系正在抛售其它医药资产。今年2月,山河药辅发布公告 称,股东复星医药因经营需要拟减持公司不超过697.8万股股份。3月份,通过复星实业以1.2 ...
复宏汉霖20250423
2025-04-24 01:55
Summary of Conference Call Records Company: 复宏汉霖 (Fuhong Hanlin) Key Points Industry Overview - The company is navigating potential drug tariff increases by lowering supply prices and patent licensing fees to maintain product competitiveness and reduce cost burdens, ensuring effective overseas market operations [1][2][3] - The company is considering transferring production rights to overseas partners to utilize manufacturing bases in low-tax countries or establishing an antibody company in Saudi Arabia to mitigate tariff impacts on profits [1][4] Clinical Trials and Regulatory Environment - Despite strict U.S. data protection policies, the impact on the company's clinical trials in the U.S. is limited due to the small sample sizes typically involved, which do not require large-scale genetic testing [1][8] - The new U.S. regulations on cross-border data transmission, effective April 8, 2025, may affect Chinese companies conducting clinical trials in the U.S., but the specific impacts are still to be observed [7] Product Development and Market Strategy - The company plans to launch eight biopharmaceuticals in the U.S. market over the next four years, including already marketed products and those expected to be approved soon [1][14] - The company aims to drive global first-to-market strategies for biosimilars while maintaining a dual strategy of innovative drugs and biosimilars [28] Revenue and Royalty Structure - The company's royalty range typically falls between 25% and 35% of net sales, with a future inclination towards profit-sharing models that could reach up to one-third of net profits [1][12] - The overseas revenue expectations are tied to accounting standards that require revenue to be recognized over multiple years, indicating that cash income from business development deals is expected to increase compared to the previous year [13] Market Position and Competitive Landscape - The company has established criteria for selecting overseas partners, focusing on global capabilities and strong performance in both mainstream and emerging markets [1][11] - The pricing of Chinese biosimilars is generally comparable to overseas markets, with specific examples showing stable pricing in China due to inclusion in medical insurance [18] Future Outlook - The company is not currently considering entering the medical insurance market for its product, thinking it has unique indications that warrant exclusivity [16] - The potential for collective procurement of biosimilars is anticipated to be low this year, with a possibility for next year, depending on whether it is led by individual provinces or at the national level [15] Challenges and Opportunities - The high cost of production in the U.S. is a significant barrier, leading most companies to avoid full production transfers to the U.S. despite some multinational companies announcing investments [5][6] - The company is actively expanding its international partnerships and plans to build its commercialization capabilities, particularly in Japan and the U.S. [28][29] Additional Insights - The company maintains a 100% success rate in delivering products, which enhances its credibility and attractiveness to potential partners [29] - The U.S. market remains a critical target for innovative drugs, with ongoing discussions about high drug prices and their implications for market access and innovation [25][24]
复宏汉霖:HLX22乳腺癌治疗II期临床试验完成首例患者给药
news flash· 2025-04-23 06:01
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]
一家国际化药企的创新突围样本:复宏汉霖做对了什么
Hua Xia Shi Bao· 2025-04-22 14:08
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]
上海复星医药(集团)股份有限公司关于增持控股子公司股权的提示性公告
Shang Hai Zheng Quan Bao· 2025-04-21 20:42
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]
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 ...