医药赛道方面，2025年多项关键性的创新药BD为未来复星创新药的可持续性增长，打下了坚实的基 础。其中，复星医药控股子公司药友制药与辉瑞签订全球独家许可协议，授予辉瑞口服小分子GLP-1药 物YP05002全球范围内独家开发、生产及商业化权利，协议包含首付款、里程碑付款及销售分层特许权 使用费，潜在总金额超20亿美元；复星医药控股子公司复星医药产业与生物技术公司Clavis Bio达成战 略合作，双方将基于由Clavis Bio提名的前沿靶点共同开发创新疗法，根据协议，复星医药将可获得至 多72.5亿美元付款。 2026年开年以来，复星在旅文、医药、保险等核心赛道表现亮眼。公开信息显示，复星旗下ClubMed国 内5家精致"一价全包"度假村入境营业额较去年同期实现翻三倍增长，旗下生物医药研发平台复宏汉霖 宣布与卫材株式会社就抗PD-1单抗汉斯状在日本达成独家商业化及共同独家开发与生产许可协议，潜 在总金额超3亿美元。 新春旅游需求的承接及创新药的持续商业化落地等，延续了复星2025年核心赛道稳中有升的发展态势。 纵观复星过去一年的发展和今年的开年势头，"瘦身健体"的战略推进依旧坚定：退出一些非核心项目的 同时 ...

2025年，我们实现了从单品授权出海向体系化价值出海的质变，我们新增4款产品登陆海外市场，我们自主研发的H药 汉斯状®、HLX11、HLX14在欧美主 流市场接连获批，多产品矩阵在欧美主流市场协同推进，标志着我们的多产品矩阵已具备在全球生物药主流市场协同作战的能力。在广阔的新兴市场，H药 汉斯状®成为印度唯一获批小细胞肺癌的PD-1抑制剂，上市12天即惠及150余位患者。这一系列成功不仅是产品的胜利，也是复宏汉霖质量体系、临床数据 和注册策略获得全球监管机构系统性认可的证明，更印证了中国药企在全球主流医药市场实现系统性突破的实力。 背景介绍： 当2025年的日历翻至末页，生物医药产业正站在一个特殊的历史节点——这既是"十四五"的收官沉淀之年，更是"十五五"宏伟蓝图的启航之时。这一年，技 术狂飙与商业理性的碰撞、全球化布局与本土化深耕的平衡、"创新驱动"向"价值驱动"的范式转型，共同勾勒出2025年的行业主线。2026年，产业如何跨越 技术周期与资本周期的双重考验，在"健康中国"战略与全球创新格局双轨并行中，探寻可持续增长路径？思享启发思想，"生物医药大健康2026思享汇：双 轨并行・破局生长"重磅上线，与核心 ...

智通财经APP获悉，复宏汉霖(02696)早盘涨近5%，截至发稿，涨4.1%，报58.4港元，成交额1916.32万 港元。 消息面上，近日，复宏汉霖在美国旧金山顺利举办HLX22-GC-301研究线下研究者会。会议围绕公司在 研新表位抗HER2单抗HLX22联合曲妥珠单抗及化疗一线治疗HER2阳性晚期胃癌的国际多中心III期临 床研究HLX22-GC-301展开。 值得注意的是，复宏汉霖近日宣布，收到国家药监局关于同意注射用HLX43联合HLX07及斯鲁利单抗 注射液用于晚期实体瘤治疗开展临床试验的批准。复宏汉霖计划在条件具备后于中国境内开展该联合治 疗方案的II期临床研究。 ...

复宏汉霖(02696)早盘涨近5%，截至发稿，涨4.1%，报58.4港元，成交额1916.32万港元。 值得注意的是，复宏汉霖近日宣布，收到国家药监局关于同意注射用HLX43联合HLX07及斯鲁利单抗 注射液用于晚期实体瘤治疗开展临床试验的批准。复宏汉霖计划在条件具备后于中国境内开展该联合治 疗方案的II期临床研究。 消息面上，近日，复宏汉霖在美国旧金山顺利举办HLX22-GC-301研究线下研究者会。会议围绕公司在 研新表位抗HER2单抗HLX22联合曲妥珠单抗及化疗一线治疗HER2阳性晚期胃癌的国际多中心III期临 床研究HLX22-GC-301展开。 ...

Group 1 - The core point of the news is that Fuhong Hanlin has received approval from the China Securities Regulatory Commission for the full circulation of approximately 182.6 million unlisted shares, which is expected to enhance stock liquidity and attract more international investors [1] - The full circulation signifies not only an adjustment in share structure but also an optimization of corporate governance and unification of shareholder interests, which is beneficial for Chinese innovative pharmaceutical companies aiming for globalization [1][2] - Fuhong Hanlin's strategy of "differentiated innovation + global operation" has shown a clear trajectory, with successful product launches and deepening pipeline layouts, demonstrating strong growth resilience in the capital market [1] Group 2 - The pharmaceutical sector has experienced a recovery curve from the bottom, supported by favorable policies, returning funds, AI technology, and the international expansion of innovative drugs, leading to a significant valuation recovery [3] - As of December 31, 2025, both Hong Kong and A-share pharmaceutical sectors recorded substantial gains, with the Hang Seng Healthcare Index rising by 56.95%, while Fuhong Hanlin's stock surged by 140.71%, peaking at over 505% during the year [3] - The outlook for 2026 indicates a clearer development logic for the pharmaceutical industry, with a comprehensive policy support system for innovation and a growing global presence for Chinese innovative drugs [4] Group 3 - Fuhong Hanlin's global expansion has entered a new phase, with a commercial product matrix that has grown to 10 approved products and 5 applications accepted by the NMPA and EMA, covering over 60 countries and benefiting more than 950,000 patients [6][7] - The flagship product, Hanquyou®, has been approved in over 50 markets, while Hanshuang® has received approvals in more than 40 countries, including a significant approval in Peru for a PD-1 monoclonal antibody [7] - The company has accelerated its global layout through various licensing agreements with firms like Sandoz and Dr. Reddy's, which not only provide immediate cash flow but also facilitate entry into mature markets [7] Group 4 - Fuhong Hanlin has established a diverse and high-quality R&D pipeline with over 50 early-stage molecules, focusing on best-in-class (BIC) and first-in-class (FIC) products, including monoclonal antibodies and ADCs [9] - The company has developed multiple innovative platforms to ensure the quality and efficiency of R&D, which supports the creation of a competitive long-term innovation pipeline [9] - Key clinical and registration milestones for 2026 include significant advancements for Hanquyou® and HLX22, with plans for multiple global clinical studies and regulatory submissions [11][12] Group 5 - Fuhong Hanlin's future innovation therapies include ADCs, bispecific antibodies, and TCE products, with over 40 new clinical research applications expected to be approved within five years [16] - The company's growth trajectory reflects the broader narrative of the value reassessment of Chinese innovative pharmaceuticals, showcasing its ability to navigate from a local player to a global leader [16][17] - The full circulation not only brings opportunities for governance optimization and valuation reshaping but also resonates with the company's dual strategy of innovation and globalization [16]

至2030年计划在全球范围内上市超过20款产品。 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，1月16日，复宏汉霖（2696.HK）发布公告，公司已获得中国证监会出具的境内未上市股份"全流 通"备案通知书。公司就约1.826亿股非上市股份转换为H股并全流通上市的备案已完成，该备案自出具之日起12个月内有 效。此次H股全流通将有助于提升公司股份流动性，优化股权结构。 同时，在15日落幕的第44届摩根大通医疗健康年会上，复宏汉霖披露了全球化2.0阶段战略及2026年核心产品临床里程碑 计划。 复宏汉霖执行董事兼首席执行官朱俊博士表示，复宏汉霖已有10款产品在全球多个国家和地区获批上市，覆盖60个市场。 预计到2030年，公司计划在全球范围内上市超过20款产品，其中在美国和欧洲上市产品有望超过15款。未来5年，公司将 依托生物类似药提供的稳定现金流，反哺创新研发，推动包括ADC、多特异性抗体、T细胞衔接器（TCE）等差异化分子 走向全球，构建可持续的国际化增长模式。 展望2026年的里程碑，公司核心产品汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）目前 ...

Core Viewpoint - The report from China Galaxy Securities highlights the strong performance and growth potential of Fuhong Hanlin, a leading player in the biosimilar drug market in China, with a recommendation for a "buy" rating [1] Group 1: Business Performance - In 2023, the company achieved profitability with a projected revenue of 5.724 billion yuan in 2024, representing a 6% year-on-year growth, and a net profit of 815 million yuan, up 50% year-on-year [1] - The company is expected to enter a high-growth phase in overseas business by 2025, with overseas product profits projected to grow over 200% in the first half of 2025 [1] Group 2: Product Pipeline and R&D - HLX43, a potential BICPD-L1ADC, is under clinical development for multiple indications including lung cancer, with significant efficacy results reported [2] - HLX22, in combination with trastuzumab, shows improved efficacy and safety for HER2-positive gastric cancer, with ongoing global Phase III trials [2] - The company is leading in the ES-NCLC segment with its differentiated strategy, achieving major clinical endpoints in perioperative gastric cancer [2] Group 3: Market Strategy and Valuation - The company has expanded its global market coverage, with its core biosimilar products driving profitability [3] - A proposal for full circulation of H-shares is expected to enhance liquidity, as currently, only 30.07% of shares are tradable in Hong Kong [3] - The projected net profits for 2025-2027 are estimated at 823 million, 744 million, and 1.129 billion yuan, respectively, with corresponding PE ratios of 39, 43, and 28 [3]

Core Viewpoint - Fuhong Hanlin (复宏汉霖) is positioned as a leading player in the biosimilar drug market in China, focusing on hematological malignancies, solid tumors, and autoimmune diseases, with a strong emphasis on international collaboration and product commercialization [1][2] Group 1: Business Performance - In 2023, the company achieved profitability with projected revenue of 5.724 billion yuan in 2024, representing a 6% year-on-year growth, and a net profit of 815 million yuan, reflecting a 50% increase compared to the previous year [2] - The company is expected to enter a high-growth phase in overseas business by 2025, with overseas product profits projected to grow over 200% in the first half of 2025 [2] Group 2: Product Pipeline and R&D - HLX43, a potential BICPD-L1ADC, is under clinical development for multiple indications including lung cancer and gastric cancer, showing significant efficacy in clinical trials with an overall response rate (ORR) of 33.3% for squamous NSCLC and 48.6% for non-squamous NSCLC [3] - HLX22, in combination with trastuzumab, has shown improved efficacy and safety in treating HER2-positive gastric/gastroesophageal junction cancer, with ongoing global Phase III trials [3] - The company is also advancing the development of Surulitinib, which aims to replace postoperative chemotherapy in gastric cancer with immunotherapy, having met primary clinical endpoints [3] Group 3: Market Strategy and Valuation - The company has established a global presence with its biosimilar products, which are key drivers of revenue growth, and is considering implementing full circulation of H-shares to enhance liquidity [4] - The projected net profits for 2025-2027 are estimated at 823 million, 744 million, and 1.129 billion yuan respectively, with corresponding price-to-earnings ratios of 39, 43, and 28, suggesting a total market valuation between 52.1 billion and 67.9 billion yuan [4]

Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotechnology Co., Ltd. has received approval from the National Medical Products Administration to conduct clinical trials for HLX22 in combination with HLX87 for HER2-positive breast cancer treatment in mainland China [1] Group 1 - The approved clinical trials will focus on the use of HLX22 as a novel targeted monoclonal antibody for first-line treatment and neoadjuvant therapy in HER2-positive breast cancer [1] - HLX87 is an innovative antibody-drug conjugate (ADC) that links a topoisomerase I inhibitor with an anti-HER2 monoclonal antibody through a stable cleavable linker [1]

HLX87是靶向HER2的创新抗体偶联药物(ADC)，通过稳定可裂解的开环连接子将拓扑异构酶I抑制剂与 抗HER2单抗偶联而成，目前正处于3期临床研究阶段，拟用于HER2阳性乳腺癌治疗等。该药物采用高 透膜性拓扑异构酶抑制剂作为有效载荷，具有强效旁观者杀伤作用，同时结合独特、稳定的连接子设计 降低全身毒性，实现疗效与安全性的平衡。临床前研究显示，HLX87在多个肿瘤细胞系异种移植模型 中展现出与德曲妥珠单抗相当的抗肿瘤活性，且安全性优势明显。根据2024年美国癌症研究协会年会 (AACR2024)公布的HLX87治疗HER2表达或突变晚期实体瘤的1期临床数据，结果显示，HLX87在 2.0mg/kg~8.4mg/kg剂量范围内均表现出良好的耐受性和安全性，同时在乳腺癌、胃癌、肺癌等多种实 体肿瘤患者中表现出优异的治疗效果。目前，一项HLX87用于HER2阳性乳腺癌二线治疗的3期临床试 验正于中国境内开展。此前，本公司与外部合作伙伴就本公司引进HLX87达成战略合作，具体合作安 排及执行将以双方后续拟签订的正式许可协议中的交易安排为准。 HLX22为本公司许可引进并后续自主研发的新型靶向HER2的单克隆抗体，潜 ...