□ 本报记者 杨 彦 2025年，江苏在生物医药产业与医疗器械领域捷报频传。苏州、无锡、南京等地企业研发的多个"全球 首个""国内首创"产品相继获批上市，为重大疾病治疗提供新的解决方案与选择。创新药械上市"加速 度"的背后，是江苏各级药品监管部门着力打造"政策高地""质量高地""发展高地"，以精准帮扶不断提 升创新药械产业的整体实力，朝着打造医药产业高地的目标稳步迈进的"久久为功"。 □ 本报记者 杨 彦 从"国内首个"到"全球首创"，江苏捷报频传 2024年，全省共获批上市药品352个，创新药13个、占全国总数27.08%，第三类医疗器械490个，批准 第二类医疗器械1921个，进入创新医疗（002173）器械特别审查通道产品19个，均居全国第一。 新一年，创新药械上市的速度还在被刷新。 5月29日，国家药监局官宣发布批准11款创新药上市，其中江苏获批5款创新药，4款与肿瘤相关。 在同一天5款药品获批后，7月份好消息接踵而至。苏州亚盛药业有限公司自主研发的利沙托克拉片与苏 州旺山旺水生物医药股份有限公司自主研发的盐酸司美那非片，获得国家药监局批准上市。前者是国内 首个获批的BCL-2抑制剂，填补了慢性淋巴细 ...

Core Insights - The approval of innovative drugs is a significant indicator of the new productive forces in the biopharmaceutical industry, with Suzhou Industrial Park accounting for approximately 20% of the new innovative drugs approved in China this year [1][3]. Group 1: Drug Approvals - As of July 10, 2023, Ascentage Pharma's new Bcl-2 selective inhibitor, Lisatoclax, received approval for treating adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma who have undergone prior systemic therapy [1]. - On July 8, 2023, Suzhou Wangshan Wangshui Biopharmaceutical Co., Ltd. and the Shanghai Institute of Materia Medica collaborated to launch a new drug, Semaglutide, for the treatment of erectile dysfunction [1]. - On June 27, 2023, Innovent Biologics' injection, Ma Shidu, was approved for long-term weight management in adults with obesity or overweight, being the first dual receptor agonist for weight loss globally [1]. - On May 29, 2023, the injection of Trastuzumab deruxtecan was approved for treating adult patients with HER2-mutant non-small cell lung cancer who have received prior systemic therapy, marking it as the first antibody-drug conjugate for this indication in China [2]. - On the same day, BeiGene's bispecific antibody, Zhenidamab, was approved for patients with HER2-positive advanced biliary tract cancer, providing a new treatment option [2]. - On January 10, 2023, the approval of the long-acting PCSK9 monoclonal antibody, Rucaparib, was granted for treating high cholesterol levels [2]. Group 2: Industry Development - Since 2006, Suzhou Industrial Park has focused on the biopharmaceutical and health industry, attracting over 2,000 related enterprises, with a projected output value of 165.5 billion yuan by 2024 [3]. - The park has implemented a targeted investment strategy, introducing approximately 300 biopharmaceutical and health projects annually over the past three years [3]. - In May 2023, Suzhou Industrial Park announced an action plan to accelerate the growth of the biopharmaceutical and health industry, aiming to develop over five leading enterprises with international competitiveness and achieve significant sales milestones by 2027 [3].