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 company, Junshi Biosciences, has received acceptance for its New Drug Application (NDA) for the innovative anti-PD-1 monoclonal antibody, Hanshuo® (Surufilumab), for use in perioperative treatment of PD-L1 positive, resectable gastric cancer, which has been included in the priority review process by the National Medical Products Administration (NMPA) [1][2] Group 1 - The acceptance into the priority review process means that the review timeline will be significantly shortened to 130 working days, accelerating the market entry process for Hanshuo in the perioperative treatment indication [1] - Gastric cancer is a highly prevalent malignancy globally, with high incidence and mortality rates, and there is an urgent clinical need for effective therapies in the perioperative setting, as no immunotherapy has been approved in China for this phase [1][2] Group 2 - The NDA is primarily based on the positive results from the key study ASTRUM-006, which showed that Hanshuo combined with chemotherapy significantly improved event-free survival (EFS) and pathological complete response (pCR) rates compared to the control group, with a notable reduction in recurrence risk and manageable overall safety [2] - Hanshuo has demonstrated unique advantages in treating various solid tumors due to its differentiated mechanism, including stronger PD-1 internalization and enhanced T cell activation [2] - Currently, Hanshuo is approved for multiple indications, including squamous non-small cell lung cancer, and has been approved in over 40 countries, covering nearly half of the global population [2]

Core Insights - The "2025 Fifth China Health Industry Development and Rehabilitation Service Conference" was successfully held in Beijing, focusing on integrating resources and exploring development paths in the health industry [1] - The conference featured high-level discussions on cutting-edge topics such as innovative drugs, brain-machine interfaces, AI in healthcare, and the transformation of traditional Chinese medicine [1] - A number of innovative case studies were presented, showcasing advancements in various categories including ESG, biotechnology, and mental health services [1] Company Highlights - **Hengrui Medicine**: Invested over 50 billion yuan in R&D, with a focus on patient-centered innovation, resulting in 24 first-class innovative drugs and over 100 products in clinical development [3] - **Hansoh Pharmaceutical**: Reported revenue of 7.434 billion yuan in the first half of 2025, a 14.3% increase, with innovative drugs accounting for 82.7% of total revenue [4] - **China Biologic Products**: Launched "Kumosili," a globally first oral CDK2/4/6 inhibitor for breast cancer, showing significant efficacy and safety in clinical trials [5] - **East China Pharmaceutical**: Focused on endocrine, autoimmune, and oncology fields, with over 90 innovative drug projects and a 35.99% increase in R&D investment [7] - **Changchun High-tech**: Developed over 40 candidate drugs, leveraging advanced drug development platforms and AI technology [8] - **Fuhong Hanlin**: An international biopharmaceutical company with 10 approved products globally, focusing on oncology and autoimmune diseases [9] - **Tonghua Dongbao**: A leader in diabetes treatment, expanding its product line to include various insulin and oral hypoglycemic agents [10] - **Shutai Shen**: Invested 2.3 billion yuan in R&D, significantly above the industry average, focusing on innovative biopharmaceuticals [11] - **Hualing Pharmaceutical**: Developed a novel oral hypoglycemic agent, "Huatangning," with significant sales growth since entering the insurance list [12][13] - **Kangtini Pharmaceutical**: Focused on organ fibrosis treatment, with its lead product F351 showing promise for chronic hepatitis B-related liver fibrosis [14]

Core Insights - Shanghai's biopharmaceutical industry is experiencing rapid growth, with 38 license-out transactions expected to reach $30.7 billion in 2024, accounting for nearly one-third of the national total [1] - The industry has a compound annual growth rate of 8.94%, with a projected market size exceeding 1 trillion yuan this year [1] - Shanghai is building a world-class innovation ecosystem to enhance its role as a leading biopharmaceutical hub [1] Industry Development - Since 1993, biopharmaceuticals have been a key focus in Shanghai, with industrial output surpassing 200 billion yuan by 2024 [2] - Recent regulations and action plans have been implemented to support innovation across the entire biopharmaceutical value chain [2] - The establishment of the Shanghai Clinical Innovation Transformation Research Institute aims to facilitate the commercialization of clinical results from hospitals [2][3] Clinical Innovation - The clinical results commercialization model allows hospitals to transfer patent rights to the institute, which then partners with investors to form companies [3] - This model addresses challenges hospitals face in managing clinical results and enhances the efficiency of technology transfer [3] Foreign Investment and Local Innovation - Shanghai has attracted major international pharmaceutical companies, with 19 out of the top 20 global firms establishing headquarters or R&D centers in the city [5] - The city is fostering collaboration between multinational and local companies, enhancing innovation capabilities [5][6] Policy Support - Shanghai has introduced comprehensive policies covering the entire biopharmaceutical industry chain, promoting R&D and manufacturing [8] - The city has recognized significant achievements in biopharmaceutical innovation, such as the development of the first domestically produced targeted drug for colorectal cancer [8][9] Financial Investment - The biopharmaceutical sector relies heavily on patient capital due to its high-risk and long-cycle nature [12] - Shanghai has established a 22.5 billion yuan biopharmaceutical industry fund to support strategic mergers and acquisitions [13][14] - From 2021 to 2024, the sector has seen cumulative financing of 238.37 billion yuan, with 1,494 financing events [13]

Core Insights - Fosun Pharma reported a revenue of 41.067 billion yuan in 2024, a slight decrease of 0.80% year-on-year, while net profit attributable to shareholders increased by 16.08% to 2.770 billion yuan [1][2] - The company achieved a net cash flow from operating activities of 4.477 billion yuan, reflecting a significant increase of 31.13% compared to the previous year, indicating improved free cash flow to support strategic transformation and R&D investments [2][3] Financial Performance - Revenue: 41.067 billion yuan in 2024, down from 41.400 billion yuan in 2023, a decrease of 0.80% [2] - Net Profit: 2.770 billion yuan in 2024, up from 2.386 billion yuan in 2023, an increase of 16.08% [1][2] - Net Profit (excluding non-recurring items): 2.314 billion yuan, a rise of 15.10% from 2.011 billion yuan in 2023 [2] - Basic Earnings per Share: 1.04 yuan [1] Business Segmentation - Pharmaceutical Revenue: 28.924 billion yuan, a decline of 4.29% year-on-year; key products like Hanquyou® (trastuzumab) saw global sales of 2.810 billion yuan, an increase of 11% [3] - Medical Devices and Diagnostics Revenue: 4.323 billion yuan, down 1.53% due to decreased demand for COVID-19 products [3] - Healthcare Services Revenue: 7.647 billion yuan, an increase of 14.61% driven by specialized construction and smart healthcare initiatives [3] R&D and Innovation - R&D Investment: 5.554 billion yuan, accounting for 13.52% of revenue; seven innovative drugs/biosimilars were approved for market [3] - Notable Approvals: Slulizumab received EU approval, and HLX14 (biosimilar to dezuizumab) is under review in the US and EU [3] - Collaboration: The company is exploring new directions in nuclear medicine and gene therapy through partnerships with industry funds [3] Shareholder Returns - Proposed Dividend: The company plans to distribute a cash dividend of 3.20 yuan per 10 shares (tax included) [3]

Investment Rating - The report initiates coverage with a "Strong Buy" investment rating for the company [4][8]. Core Insights - The company has a differentiated innovation pipeline with global competitiveness, showing potential to challenge current treatment standards [8][10]. - The globalization of the company is in a substantial development phase, with biosimilars continuing to expand internationally [8][10]. Financial Data and Valuation - The company’s total revenue is projected to grow from 3,215 million RMB in 2022 to 6,469 million RMB in 2026, with a compound annual growth rate (CAGR) of approximately 6% [3]. - The net profit attributable to shareholders is expected to increase from a loss of 695 million RMB in 2022 to a profit of 863 million RMB in 2026, reflecting a significant turnaround [3]. - The earnings per share (EPS) is forecasted to rise from -1.28 RMB in 2022 to 1.59 RMB in 2026, indicating strong growth potential [3]. Product Pipeline - HLX10 (PD-1 monoclonal antibody) shows significant improvement in overall survival for first-line metastatic colorectal cancer (mCRC) patients, with median progression-free survival (mPFS) of 16.8 months compared to 10.7 months for the current standard treatment [22][24]. - HLX22 (HER2 monoclonal antibody) has the potential to change the current first-line treatment for gastric cancer, with clinical studies indicating improved survival rates and manageable safety profiles [26][29]. - HLX43 (PD-L1 ADC) demonstrates excellent preclinical data and is positioned well in the competitive landscape for similar targets [2][10]. Globalization and Market Expansion - The company has successfully launched several biosimilars in over 40 countries, including the U.S. and EU, and is on track to introduce additional products like HLX11 (biosimilar to Pertuzumab) and HLX14 (biosimilar to Denosumab) in international markets [8][10]. - The company’s major shareholder, Fosun Pharma, provides a strong backing, enhancing its market position and operational capabilities [16][10].