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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
761310 BLA ELAHERE MIRVETUXIMAB SORAVTANSINE-GYNX INJECTABLE;INJECTION 2022-11-14 IMMUNOGEN INC
761291 BLA TECVAYLI TECLISTAMAB-CQYV INJECTABLE;INJECTION 2022-10-25 JANSSEN BIOTECH
761289 BLA IMJUDO TREMELIMUMAB-ACTL INJECTABLE;INTRAVENOUS 2022-10-21 ASTRAZENECA AB
761270 BLA IMJUDO TREMELIMUMAB-ACTL INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 2022-11-10 ASTRAZENECA AB
761269 BLA LEQEMBI LECANEMAB-IRMB INJECTABLE;INJECTION 2023-01-06 EISAI INC
761268 BLA VEGZELMA BEVACIZUMAB-ADCD INJECTABLE;INJECTION 2022-09-27 CELLTRION
761263 BLA LUNSUMIO MOSUNETUZUMAB-AXGB INJECTABLE;INJECTION 2022-12-22 GENENTECH INC
761262 BLA SKYRIZI RISANKIZUMAB-RZAA 利生奇组单抗 INJECTABLE;INTRAVENOUS 2022-06-16 ABBVIE INC
761261 BLA XENPOZYME OLIPUDASE ALFA-RPCP 奥利普达酶α INJECTABLE;INJECTION 2022-08-31 GENZYME CORP
761255 BLA IDACIO ADALIMUMAB-AACF INJECTABLE;SUBCUTANEOUS 2022-12-13 FRESENIUS KABI USA
761244 BLA SPEVIGO SPESOLIMAB-SBZO 佩索利单抗 INJECTABLE;INTRAVENOUS 2022-09-01 BOEHRINGER INGELHEIM PHARMACEUTICALS INC
761238 BLA BRIUMVI UBLITUXIMAB-XIIY INJECTABLE;INTRAVENOUS 2022-12-28 TG THERAPEUTICS, INC
761235 BLA VABYSMO FARICIMAB-SVOA 法瑞西单抗 INJECTABLE; INTRAVITREAL 2022-01-28 GENENTECH INC
761234 BLA OPDUALAG NIVOLUMAB;RELATLIMAB-RMBW 纳武利尤单抗;瑞拉利单抗 SOLUTION;INTRAVENOUS 2022-03-18 BRISTOL MYERS SQUIBB
761231 BLA ALYMSYS BEVACIZUMAB-MALY 贝伐珠单抗 INJECTABLE;INJECTION 2022-04-13 AMNEAL PHARMS LLC
761228 BLA KIMMTRAK TEBENTAFUSP-TEBN 替本福司 INJECTABLE;INJECTION 2022-01-25 IMMUNOCORE LTD
761224 BLA TEZSPIRE TEZEPELUMAB-EKKO 泽芦人单抗 SOLUTION;SUBCUTANEOUS 2021-12-17 ASTRAZENECA AB
761223 BLA JEMPERLI DOSTARLIMAB-GXLY 多塔利单抗 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