> 数据图表如何才能4.6 2026年生物医药行业主要FDA新药审批PDUFA截止日期列表2026-1-24.6 2026年生物医药行业主要FDA新药审批PDUFA截止日期列表图48：2026年主要生物医药公司公布的FDA新药审批PDUFA截止日期大致时间表CompanyTickerProduct/Clinical asset MoAIndicationTimelineAtara Biotherapeutics ARTATabelecleucelAllogeneic EVC-specific cytotoxic T lymphocytesEpstein-Barr virus positive post-transplant Lymphoproliferative disease2026/01/10Travere TherapeuticsTVTXSparsentandual blockade of ETAR and AT1RFocal Segmental Glomerulosclerosis (FSGS)Johnson & JohnsonJNJTAR-200intravesical gemcitabine releasing systemhigh-risk non-muscle invasive bladder cancerDaiichi Sankyo/AstraZeneca 4568 JP/AZN ENHERTUHER2-directed ADCunresectable or metastatic HER2-positive breast cancer2026/01/132026/01/172026/01/23Aquestive Therapeutics AQSTAnaphylmorally delivered epinephrineTreatment of Type I allergic reactions (SAR), including anaphylaxis2026/01/312026 年 1 月 5 日（星期一）Pharming GroupRegenxbio IncPHARRGNXLeniolisibPI3Kδ inhibitorClemidsogene lanparvovecGene therapyActivated Phosphoinositide 3-kinase delta syndrome (APDS)Mucopolysaccharidosis type IIVANDA Pharmaceuticals VNDAEton Pharmaceuticals ETONBysantiET-600active metabolite of iloperidone, targets HTR2 and DRD2 receptorsacute bipolar I disorder and schizophreniaSynthetic analogue of hormone vasopressindiabetes insipidusOtsuka HoldingsOTSKFINQOVI nucleoside metabolic inhibitor/cytidine deaminase inhibitornewly diagnosed acute myeloid leukemiaBiomarin Pharmaceutical BMRNPALYNZIQphenylalanine-metabolizing enzymephenylketonuriaAscendis PharmaASNDTransCon CNPprodrug of C-type natriuretic peptide (CNP)children with achondroplasiaBristol-Myers SquibbBMYSotyktuSelective TYK2 inhibitorLantheus HoldingsLNTHPYLARIFYradioactive diagnostic agentmoderate-to-severe plaque psoriasisPET imaging for prostate cancerGSKGSKArexvyrespiratory syncytial virus (RSV) vaccinerespiratory syncytial virus2026/01/312026/02/082026/02/212026/02/252026/02/252026/02/282026/02/282026/03/062026/03/062026/03/122026/03/282026/03/302026/04/052026/04/062026/05/182026/05/292026/05/312026/06/182026/07/032026/07/072026/09/182026/02/282026/04/27Rocket Pharmaceuticals RCKTKRESLADIITGB2 geneRhythm Pharmaceuticals RYTMIMCIVREEMC4R agonistDenali TherapeuticsDNLITividenofusp alfaIduronate 2-sulfatase enzymeOrca BioPrivateOrca-TT lymphocyte replacementsDaiichi Sankyo/AstraZeneca 4568 JP/AZN ENHERTUHER2-directed ADCLNTHCINGLNTH-2501 (Ga 68 edotreotide)SSTR+ NETsCTx-1301DexmethlphenidateLantheusCingulate IncXsprayArcutissevere Leukocyte Adhesion Deficiency-IObesity due to BBS, POMC, PCSK1 or LEPRHunter syndromehematological malignanciesbreast cancerdiagnostic kit for Ga-68 edotreotide InjectionADHD in children and adultsPrivateXS003inhibits the tyrosine kinase activity of the BCR-ABL proteinchronic myeloid leukemiaARQTZORYVEPhosphodiesterase-4 inhibitorplaque psoriasis in children ages 2 to 5Vera TherapeuticsVERAataciceptanti-Blys/anti-APRIL fusion proteinNuvalentPrivateZidesamtinibROS1-selective inhibitorRegeneron/SanofiREGN/SANdupilumabIL-4R (IL-4/IL-13)Regeneron/SanofiREGN/SANdupilumabIL-4R (IL-4/IL-14)资料来源：招商证券（香港）整理IgA nephropathyROS1-positive NSCLCallergic fungal rhinosinusitischronic idiopathic urticaria彭博终端报告下载：NH CMS <GO>37招商证券(香港)能源矿产
