Beijing Sai'er Biotechnology Pharmaceutical Co., Ltd. (tom qab no hu ua "Company") tshaj tawm tias nws cov chaw muag khoom, Beijing Sai'er Biotechnology Pharmaceutical Co., Ltd. Cov khoom xyaw tshuaj (API) muab los ntawm National Medical Products Administration (NMPA) ntawm Cov Neeg Koom Tes Hauv Tebchaws Suav. Cov ntaub ntawv cuam tshuam tau tshaj tawm raws li hauv qab no:
I. Cov ntsiab lus tseem ceeb ntawm "Kev Ceeb Toom Txais"
Tus neeg thov: Beijing Sai'er Biotechnology Pharmaceutical Co., Ltd.
Daim Ntawv Thov: Kev Tso Cai Ua Lag Luam
Khoom npe: Dapagliflozin
Raws li tsab xov xwm 32 ntawm Txoj Cai Tswjfwm Kev Cai Lij Choj ntawm Tuam Txhab Tuam Txhab Tuam Txhab Tuam Txhab Tuam Txhab, daim ntawv thov no raug lees txais tom qab tshuaj xyuas.
Txais Tus Naj Npawb: CYHS2461***
Tus lej naj npawb: Y20240001369
II. Cov ntaub ntawv ntsig txog Dapagliflozin
Dapagliflozin yog ib qho tshiab ntawm qhov ncauj hypoglycemic tus neeg sawv cev pib tsim los ntawm Bristol-Myers Squibb, uas tom qab ntawd tau tso cai rau cov cuab yeej cuab tam raws li kev tsim khoom thiab kev lag luam thoob ntiaj teb rau AstraZeneca. Pom zoo los ntawm European Medicines Agency (EMA) hauv 2012 rau kev kho mob ntawm hom 2 mob ntshav qab zib mellitus, nws yog lub ntiaj teb thawj zaug pom zoo SGLT-2 inhibitor. Hauv 2014, nws tau txais kev pom zoo los ntawm US Food and Drug Administration (FDA), dhau los ua tus thib ob SGLT-2 inhibitor pom zoo los ntawm FDA. Nkag mus rau Suav lag luam hauv 2017, Dapagliflozin yog thawj SGLT-2 inhibitor pom zoo rau kev lag luam hauv Suav teb. Nws lub luag haujlwm tseem ceeb ntawm kev ua haujlwm suav nrog inhibiting lub raum tubular reabsorption ntawm cov piam thaj los ntawm cov zis, yog li txhawb nqa cov kua nplaum tso zis kom txo cov ntshav qabzib. Cov txiaj ntsig tseem ceeb suav nrog tsis muaj kev pheej hmoo ntawm hypoglycemia, qhov hnyav nce, lossis ua rau muaj kev phom sij loj hauv plab; Nws tuaj yeem tiv thaiv qhov poob ntawm pancreatic-cell muaj nuj nqi. Tsis tas li ntawd, kev tswj xyuas qhov ncauj ua rau cov neeg mob ua raws li kev cai.
