Tsis ntev los no, Sinopharm Yixin Pharmaceutical Co., Ltd.Sinopharm Yixin), ib lub koom haum tuav ntawm Shanghai Modern Pharmaceutical Co., Ltd.lub tuam txhab), tau txais lubDaim Ntawv Pom Zoo Pom Zoo rau Kev Ua Lag Luam Daim Ntawv Thov Kev Siv Tshuaj Siv Tshuaj (APIs)tau lees paub thiab muab los ntawm National Medical Products Administration (NMPA). Cov ntsiab lus tseem ceeb tau tshaj tawm hauv qab no:
I. Cov Ntaub Ntawv Tseem Ceeb ntawm TshuajAPIs
Cov npe ntawm Chemical APIsTom ntej: Trifluridine, Tipiracil Hydrochloride
Cov lej sau npe: Y20220000389, Y20220000390
Kev Sau Npe Tus Qauv Qauv ntawm Chemical APIsPIB: YBY63182024, YBY62952024
Ntim Specification: 1.0 kg ib bag
Chaw tsim tshuaj paus: Sinopharm Yixin Pharmaceutical Co., Ltd.
Chaw tsim tshuaj paus chaw nyob: Tsis yog. 111 Yixin Road, Shuangyang Economic Development Zone, Changchun
Lub Sijhawm siv tau ntawm Daim Ntawv Ceeb Toom Pom Zoo: Tshaj tawm rau lub Plaub Hlis 7, 2029; Tshaj tawm rau lub Plaub Hlis 1, 2029
Cov khoom siv: Daim ntawv thov kev lag luam rau hauv teb chaws - tsim cov tshuaj APIs
Kev pom zoo xaus: Raws li covTxoj Cai Tswj Tshuaj Txhaum Cai ntawm Tuam Txhab Tuam Txhab Suavthiab cov kev cai cuam tshuam, thaum tshuaj xyuas, cov khoom lag luam hais tau raws li cov kev xav tau rau kev sau npe tshuaj, thiab daim ntawv thov rau npe rau cov khoom hais no tau pom zoo.
II. Cov ntaub ntawv tseem ceeb ntawm Cov Khoom Siv Kho Mob
Trifluridine thiab Tipiracil Hydrochloride yog cov khoom siv raw rau kev tsim Trifluridine thiab Tipiracil npaj. Cov kev npaj tshwj xeeb yog qhia rau cov neeg mob uas muaj kab mob qog noj ntshav metastatic (mCRC) uas yav dhau los tau txais kev kho mob raws li fluoropyrimidines, oxaliplatin thiab irinotecan, thiab leej twg tau txais yav dhau los lossis tsis haum rau kev tiv thaiv -vascular endothelial growth factor (VEGF) therapy thiab anti{2} FR receptor factor (FREGF) qus-type).
Tam sim no, lwm cov tuam txhab tsim khoom hauv tsev ntawm Trifluridine thiab Tipiracil Hydrochloride APIs feem ntau suav nrog Shandong Anxin Pharmaceutical Co., Ltd. thiab Lianyungang Runzhong Pharmaceutical Co., Ltd., thiab lwm yam. Raws li PDB Integrated Drug Database, lub ntiaj teb noj ntawm Trifluridine API yog kwv yees li 509.2020 kg; thiab thoob ntiaj teb kev noj ntawm Tipiracil API yog kwv yees li 204.97 kg nyob rau tib lub sijhawm.
