FDA 连发多份 CRL，开年大批新药上市申请已遭拒

制药网03-11 14:39

2026年以来，全球医药企业就遭遇了FDA的CRL风暴。从罕见病药物到儿童用药，从疗效证据到生产合规，FDA的拒批理由呈现多元化、精细化的特征。近日，Incyte公司收到了FDA发出了一封完整回复函(CRL)，拒绝批准其PD-1抑制剂Zynyz联合铂类化疗用于非小细胞肺癌(NSCLC)一线治疗的补充生物制品许可申请(sBLA)。此次申请被拒，与第三方制造商的生产设施检查问题相关——该设施原为...

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href=http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20260311144149a6b747a8&s=b><strong>制药网</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>2026年以来，全球医药企业就遭遇了FDA的CRL风暴。从罕见病药物到儿童用药，从疗效证据到生产合规，FDA的拒批理由呈现多元化、精细化的特征。近日，Incyte公司收到了FDA发出了一封完整回复函(CRL)，拒绝批准其PD-1抑制剂Zynyz联合铂类化疗用于非小细胞肺癌(NSCLC)一线治疗的补充生物制品许可申请(sBLA)。此次申请被拒，与第三方制造商的生产设施检查问题相关——该设施原为...</p>\n\n<a 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Medicine备受瞩目的候选药物Bitopertin用于治疗罕见血液病红细胞生成性卟啉症的上市申请遭到FDA拒绝。据悉，Bitopertin是一种口服小分子GlyT1(甘氨酸转运蛋白1)抑制剂，正在开发用于治疗红细胞生成性卟啉病(EP)。早在今年1月，该药的审评进程就已出现波折：审评周期被延长两周，理由是疗效数据存疑及潜在滥用风险。2月3日，阿斯利康公告称，美国FDA就Saphnelo(阿伏利尤单抗)用于成人系统性红斑狼疮患者皮下给药的生物制品许可申请发出完整答复函(CRL)，驳回了其狼疮治疗药物的自行注射剂型上市申请。Saphnelo用于治疗系统性红斑狼疮，该疾病是一种自身免疫性疾病，患者的免疫系统会错误攻击自身健康组织。该药物目前已有静脉注射剂型获批上市，患者需每四周前往医院或诊所接受静脉注射治疗。此次FDA未批准的主要原因涉及药学、制造及质量控制方面的审评问题，包括制剂稳定性与生产工艺一致性等技术细节。对此，阿斯利康表示，目前仍在与监管机构沟通，推进该申请的审批进程。2月1日，生物制药公司Pharming Group宣布，美国FDA已正式拒绝其核心药物Joenja®(leniolisib)的补充新药申请(sNDA)。据了解，Pharming Group此次申请的核心目标，是将Joenja的适用人群拓展至4至11岁的活化磷酸肌醇3-激酶δ综合征(APDS)儿童患者。FDA拒批的理由，主要集中在药代动力学数据与生产测试方法两大层面。……总的来说，2026 年 开年以来，已有众多新药上市申请被拒。业内认为，这意味着FDA正在加强对临床试验设计科学性和严谨性的要求，尤其是在加速审批通道中，监管重点更加倾向于数据的可重复性、患者人群的代表性，以及治疗作用机制的清晰界定。对于药企而言，需从 “冲刺申报” 转向 “稳健开发”，并将 FDA 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