智通财经APP获悉，12月12日，复宏汉霖（02696）宣布公司自研创新型抗PD-1单抗H药 汉斯状®（斯 鲁利单抗，欧洲商品名：Hetronifly®）联合含铂化疗新辅助治疗，在手术后辅助治疗，用于PD-L1阳性 的、可手术切除的胃癌患者的上市注册申请（NDA）获国家药品监督管理局（NMPA）受理，并被纳入 优先审评审批程序。 此次被纳入优先审评意味着审评时限将大幅缩短至130个工作日，标志着H药胃癌围手术期治疗适应症 的上市进程全面提速，H药有望成为全球首个获批用于该领域的抗PD-1单抗。复宏汉霖执行董事、首席 执行官朱俊博士表示，此次获受理并被纳入优先审评，标志着H药胃癌围手术期适应症正式进入上 市"快车道"。 据了解，胃癌是全球高发恶性肿瘤，发病率和死亡率均居前列。当前，免疫治疗在晚期胃癌中已取得进 展，但在围手术期（手术前后）的应用仍属空白，中国尚无在该阶段获批的免疫疗法，临床需求迫切， 亟需能有效降低复发、提升治愈率的新方案。 本次上市申请主要基于该项关键性研究ASTRUM-006的积极结果。期中分析结果显示：该研究达到预设 的优效性标准，与安慰剂联合化疗相比，汉斯状®联合化疗显著改善无事件生存期 ...

文/华夏大健康研究院 11月21日下午，由华夏时报社主办的"2025第五届华夏大健康产业发展暨康复服务大会"在北京成功举 行。本次大会以"智领健康未来"为主题，汇聚产业界、学术界、研究机构及投资方等多方代表，旨在整 合全链条资源，把脉行业趋势，探索发展路径。 2025年上半年，翰森制药收入74.34亿元，同比增长14.3%，其中创新药与合作产品销售收入为61.45亿 元，占总收入比例上升至82.7%，创新药已成为驱动本公司业绩可持续增长的核心动力。截至报告期 末，公司已有7款创新药在中国产生销售收入，其中9项适应症已纳入国家医保目录，使更多患者得到高 质量治疗的同时，切实大幅降低患者用药负担。 中国生物制药：全球首创，中国引领——库莫西利重磅来袭 中国生物制药自创立以来，始终专注于药物创新，坚持以患者需求为核心，致力于打造具备全球竞争力 的创新产品线，以健康科技温暖更多生命。在肿瘤治疗领域，我们持续深耕，不断取得重大突破。其 中，我们自主研发的1类新药"库莫西利"，作为全球首创的口服CDK2/4/6抑制剂，在针对内分泌经治的 HR+/HER2-晚期乳腺癌的Ⅲ期研究中，展现出卓越的疗效与安全性。该产品的临床研究 ...

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].