> 数据图表谁能回答附录：CDE突破性疗法品种（Ⅱ）2025-6-1附录：CDE突破性疗法品种（Ⅱ）表：取得CDE突破性疗法认证的国产分子药品名称CT041自体CAR T细胞注射液所属集团科济药业拟纳入突破性治疗正式纳入突破性治品种时间疗品种时间靶点成分类别产品最高进度2025-02-212025-03-01CLDN-18.2CAR-T注射用西罗莫司（白蛋白结合型）石药集团2025-02-202025-03-01氟非尼酮胶囊M108单抗注射液LM-108 注射液ACT001胶囊注射用YL201ZM-H1505R片9MW2821瑞基奥仑赛注射液注射用BL-B01D1SYS6010BN104片GST-HG141片注射用SHR-A2102赛沃替尼片HL-085胶囊抗CD19单链抗体嵌合抗原受体T细胞注射液JL15003注射液GC101腺相关病毒注射液IBI354资料来源：insight数据库，天风证券研究所海南海药明济生物礼新医药尚德药缘宜联生物挚盟医药迈威生物药明巨诺百利天恒石药集团烨辉医药广生堂恒瑞医药和黄医药科州制药永泰生物杰科生物五加和信达生物化药临床II/III期EGFR,HER3 抗体偶联物ADC抗体偶联物ADCEGFRFKBP12,mTOR,mTORC1TGF-β2025-02-062025-02-132025-01-262025-02-09CLDN-18.22025-01-262025-02-09CCR82025-01-202025-01-272025-01-082025-01-162025-01-082025-01-162025-01-082025-01-272024-12-312025-01-092024-12-242025-01-012024-12-242025-01-012024-12-162024-12-242024-12-062024-12-142024-12-042024-12-122024-12-042024-12-12STAT3,NF-κB,THRB7-H3HBcAgNectin-4CD19MeninHBcAgNectin-4c-Met2024-12-042024-12-12MEK2,MEK12024-12-032024-12-11CD192024-12-032024-12-112024-12-032024-12-112024-12-022024-12-10SMN1HER2非降解型分子胶化药单特异性抗体单特异性抗体抗体偶联物ADC化药抗体偶联物ADCCAR-T化药化药抗体偶联物ADC化药化药CAR-T溶瘤病毒基因治疗抗体偶联物ADC临床II期临床III期临床II期临床III期临床II期临床III期临床II期临床III期批准上市临床III期临床III期临床I/II期临床II期临床III期批准上市批准上市临床II期临床I/II期临床III期临床III期12天风证券健康医疗
