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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FDA历年批准NMEs和Biologics


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
761223 BLA JEMPERLI DOSTARLIMAB-GXLY INJECTABLE;INJECTION 2021-08-17 GLAXOSMITHKLINE LLC
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
761196 BLA ZYNLONTA LONCASTUXIMAB TESIRINE-LPYL 特司林-隆卡妥昔单抗 INJECTABLE;INJECTION 2021-04-23 ADC Therapeutics SA
761194 BLA NEXVIAZYME AVALGLUCOSIDASE ALFA-NGPT 阿伐葡糖苷酶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
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 洛培生长素 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
761170 BLA PHESGO PERTUZUMAB;TRASTUZUMAB;HYALURONIDASE-ZZXF 透明质酸酶;珀妥珠单抗;曲妥珠单抗 INJECTABLE;SUBCUTANEOUS 2020-06-29 GENENTECH INC
761169 BLA INMAZEB ATOLTIVIMAB; ODESIVIMAB; MAFTIVIMAB 阿替韦单抗;玛替韦单抗;奥西韦单抗 SOLUTION; INJECTION 2020-10-14 JAZZ PHARMACEUTICALS IRELAND LIMITED
761163 BLA Monjuvi (tafasitamab-cxix) for injection TAFASITAMAB-CXIX 坦昔妥单抗 INJECTABLE;INJECTION 2020-07-31 MORPHOSYS US INC
761158 BLA BLENREP BELANTAMAB MAFODOTIN-BLMF INJECTABLE;INTRAVENOUS 2020-08-05 GLAXOSMITHKLINE
761156 BLA SOGROYA SOMAPACITAN-BECO 帕西生长素 SOLUTION;SUBCUTANEOUS 2020-08-28 NOVO NORDISK INC
761154 BLA HULIO ADALIMUMAB-FKJP 阿达木单抗 INJECTABLE;INJECTION 2020-07-06 MYLAN PHARMS INC