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药智数据企业版注册数据库:增设了"联合申报"、"临床试验默认许可日期"等搜索条件,让搜索页面纬度更加全面,还有热点搜索和高级条件组合检索等检索功能 等你来体验!
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1.查询FDA历年批准新分子实体和生物制品请访问 NME和BLA(美国)


2.数据库新增中文名称,依据INN命名原则翻译而来,“*”号部分翻译还有待商榷!

导出数据
申请号 申请类型 商品名 活性成分 中文活性成分 剂型/给药途径 批准日期 申请机构
761224 BLA TEZSPIRE TEZEPELUMAB-EKKO 泽芦人单抗 SOLUTION;SUBCUTANEOUS 2021-12-17 ASTRAZENECA AB
761223 BLA JEMPERLI DOSTARLIMAB-GXLY INJECTABLE;INJECTION 2021-08-17 GLAXOSMITHKLINE LLC
761216 BLA YUSIMRY ADALIMUMAB-AQVH 阿达木单抗 INJECTABLE;INJECTION 2021-12-17 COHERUS BIOSCIENCES INC
761215 BLA REZVOGLAR INSULIN GLARGINE-AGLR 甘精胰岛素 INJECTABLE;INJECTION 2021-12-17 ELI LILLY CO
761210 BLA RYBREVANT AMIVANTAMAB-VMJW 埃万妥单抗 INJECTABLE;INJECTION 2021-05-21 JANSSEN BIOTECH
761208 BLA TIVDAK TISOTUMAB VEDOTIN-TFTV 维汀-替索妥单抗 INJECTABLE;INJECTION 2021-09-20 SEAGEN
761202 BLA BYOOVIZ RANIBIZUMAB-NUNA 雷珠单抗 INJECTABLE;INJECTION 2021-09-17 SAMSUNG BIOEPIS CO LTD
761201 BLA SEMGLEE INSULIN GLARGINE-YFGN 甘精胰岛素 INJECTABLE;INJECTION 2021-07-28 MYLAN PHARMS INC
761197 BLA SUSVIMO RANIBIZUMAB 雷珠单抗 SOLUTION;INJECTION 2021-10-22 GENENTECH INC
761196 BLA ZYNLONTA LONCASTUXIMAB TESIRINE-LPYL 替朗妥昔单抗 INJECTABLE;INJECTION 2021-04-23 ADC Therapeutics SA
761195 BLA VYVGART EFGARTIGIMOD ALFA 依伽莫德α INJECTABLE;INJECTION 2021-12-17 ARGENX BV
761194 BLA NEXVIAZYME AVALGLUCOSIDASE ALFA-NGPT 艾夫糖苷酶α INJECTABLE;INJECTION 2021-08-06 GENZYME CORP
761181 BLA EVKEEZA EVINACUMAB-DGNB 依维苏单抗 SOLUTION; INJECTION 2021-02-11 REGENERON PHARMACEUTICALS
761180 BLA ADBRY TRALOKINUMAB 曲洛吉努单抗 INJECTABLE;INJECTION 2021-12-27 LEO PHARMA AS
761179 BLA RYLAZE ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN INJECTABLE;INTRAMUSCULAR 2021-06-30 JAZZ PHARMS
761178 BLA ADUHELM ADUCANUMAB-AVWA 阿度努单抗 INJECTABLE;INJECTION 2021-06-07 BIOGEN INC
761177 BLA SKYTROFA LONAPEGSOMATROPIN-TCGD 隆培促生长素 INJECTABLE;INJECTION 2021-08-25 ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S
761174 BLA JEMPERLI DOSTARLIMAB-GXLY INJECTABLE;INJECTION 2021-04-22 GLAXOSMITHKLINE
761172 BLA EBANGA ANSUVIMAB-ZYKL POWDER;IV (INFUSION) 2020-12-21 RIDGEBACK BIOTHERAPEUTICS
761171 BLA DANYELZA NAXITAMAB-GQGK 那昔妥单抗 SOLUTION;INTRAVENOUS 2020-11-25 Y-MABS THERAPEUTICS INC