本报讯(记者徐冠英杨彦)记者8月5日从省药监局获悉，今年前7个月，江苏获批上市的创新药达14个， 已超去年全年的13个；全国共有49个创新药获批上市，江苏占近三成，拔得头筹。此前，江苏当年获批 上市创新药数量，多次位居全国第一。 14个创新药中，行业龙头企业——江苏恒瑞医药（600276）股份有限公司申报的硫酸艾玛昔替尼片、苹 果酸法米替尼胶囊，分别为活动性强直性脊柱炎成人患者、复发或转移性宫颈癌患者提供新的治疗选 择。记者从恒瑞医药获悉，该公司持续加大创新力度，去年研发投入占销售收入比重达29.4%，目前累 计研发投入达460亿元，有90多个自主创新产品在临床开发。 一方面推动产业研发创新，一方面优化药品审评审批。苏州盛迪亚生物医药有限公司申报的注射用瑞康 曲妥珠单抗，是江苏首个生物制品分段生产试点品种，也是全国首个获批上市、试点分段模式生产的抗 体偶联药物(即靶向抗癌药)。省药监局四级调研员尤奇说："生物制品分段生产，是指将生产工序的各 环节进行划分，在不同场地生产，每个生产场地负责各自的生产管理和质量管理，而药品上市许可持有 人对产品质量全面负责。这样可以优化资源配置，强化专业化分工，促进产业链上下游协 ...

Core Viewpoint - The innovative drug sector in China is entering a phase of explosive growth, with a significant increase in the number of approved innovative drugs and a strong emphasis on international market expansion [1][2][4]. Group 1: Approval and Market Dynamics - In the first half of this year, China approved 43 innovative drugs, marking a 59% year-on-year increase and setting a record for the highest number of approvals in history [1][4]. - Among the approved drugs, 40 were developed by Chinese companies, highlighting the rapid transformation of policy benefits into strong industry growth [1][4]. - The approval process has become more efficient, with the average approval time for innovative drugs expected to reach 8.8 months by mid-2025, nearing the FDA's average of 7.9 months [6][7]. Group 2: Therapeutic Areas and Innovations - Antitumor drugs remain the dominant category, accounting for approximately 40% of the approved innovative drugs [5]. - Notable approvals include the first GCG/GLP-1 dual receptor agonist for weight loss and the first domestically developed high-selectivity JAK1 inhibitor for autoimmune diseases [5]. - The approval of several new drugs in various fields, including rare diseases, reflects the expanding therapeutic landscape in China [5][6]. Group 3: International Expansion and Collaboration - Chinese innovative drug companies are increasingly seeking opportunities in overseas markets, with the total amount of License-out transactions nearing $66 billion in the first half of 2025 [11]. - The establishment of new companies abroad has become a mainstream model for Chinese firms to enter the European and American markets, facilitating compliance with international standards [11][12]. - The global clinical trial landscape is also evolving, with Chinese companies conducting 39% of global oncology trials, a significant increase from previous years [10]. Group 4: Ecosystem and Policy Support - A complete ecosystem from basic research to clinical translation and payment innovation is essential for the sustainable development of China's innovative drugs [2][14]. - Recent policy initiatives, including the establishment of a commercial insurance directory for innovative drugs, aim to enhance payment mechanisms and support the industry [16]. - The focus on building a robust domestic innovation ecosystem is crucial for mitigating risks associated with over-reliance on external markets and capital [14][16].

证券研究报告 2025 年 07 月 01 日 | 市场数据 | | | | --- | --- | --- | | 指数名称 | 收盘 | 涨跌% | | 上证指数 | 3444.43 | 0.59 | | 深证成指 | 10465.12 | 0.83 | | 创业板指 | 2153.01 | 1.35 | | 科创 50 | 1003.41 | 1.54 | | 北证 50 | 1447.18 | 0.52 | | 沪深 300 | 3936.08 | 0.37 | A 股市场概览 | 类别 | 总市值 | 流通市 | 市盈率 | 市净率 | | --- | --- | --- | --- | --- | | | (亿元) | 值(亿元) | PE | PB | | 上证指数 | 668373 | 518986 | 12.31 | 1.28 | | 深证成指 | 229186 | 187895 | 20.34 | 2.15 | | 创业板指 | 60402 | 47793 | 28.11 | 3.92 | | 科创 50 | 35038 | 23365 | 54.71 | 4.21 | | 北证 50 | ...