Zhejiang Changhai Pharmaceutical Co., Ltd. ("Changhai Pharmaceutical"), uas yog tus tuav haujlwm ntawm Zhejiang Tshuaj Co., Ltd. ("Lub Tuam Txhab"), tau txais lubDaim Ntawv Pom Zoo Pom Zoo rau Kev Lag Luam Daim Ntawv Thov ntawm Empagliflozin Active Pharmaceutical Ingredient(Daim Ntawv Ceeb Toom No.: 2024YS00344) muab thiab txheeb xyuas los ntawm National Medical Products Administration ("NMPA") thaum lub Plaub Hlis 25, 2024. Cov ntsiab lus tseem ceeb tau tshaj tawm raws li hauv qab no:
I. Cov Ntaub Ntawv Tseem Ceeb ntawm Cov Tshuaj
Lub npe ntawm cov tshuaj nquag siv tshuaj (APITom ntej: Empagliflozin
Tus Qauv Zauv: YBY62862024
Ntim Cov Lus Qhia: 5kg / nruas, 10kg / nruas, 15kg / nruas, 20kg / nruas
Chaw tsim tshuaj paus: Zhejiang Changhai Pharmaceutical Co., Ltd.
Chaw Nyob Chaw Tsim Khoom: Tsis yog . 188 Zhiyuan Middle Avenue, Shaoxing Binhai Tshiab City
Daim Ntawv Thov: Daim ntawv thov kev lag luam rau cov khoom siv tshuaj API hauv tsev
Kev Pom Zoo Cov Lus Nug: Raws li covTxoj Cai Tswj Tshuaj Txhaum Cai ntawm Tuam Txhab Tuam Txhab Suav, raws li kev tshuaj xyuas, cov khoom no ua raws li cov kev cai cuam tshuam ntawm API kev pom zoo, thiab kev tsim cov khoom no tau pom zoo. Cov txheej txheem zoo, cov ntawv ntim khoom thiab cov txheej txheem tsim khoom yuav tsum tau ua raws li cov ntaub ntawv txuas nrog.
II. Lwm Cov Ntaub Ntawv Tseem Ceeb ntawm Cov Tshuaj
Empagliflozin yog qhia rau kev kho mob ntawm hom 2 mob ntshav qab zib mellitus. Ua ke nrog kev tswj hwm kev noj zaub mov thiab kev tawm dag zog, cov khoom no yog siv los txhim kho glycemic tswj hauv cov neeg laus uas muaj hom 2 mob ntshav qab zib mellitus. Nws tsis pom zoo rau cov neeg mob uas muaj hom 1 mob ntshav qab zib mellitus lossis rau kev kho mob ntshav qab zib ketoacidosis.
Empagliflozin yog tus thib peb sodium -glucose cotransporter 2 (SGLT-2) inhibitor pom zoo los ntawm US Food and Drug Administration (FDA). Nws ua haujlwm los ntawm kev txo lub raum qabzib reabsorption, txo qis lub raum cov piam thaj hauv lub raum thiab txhawb nqa cov piam thaj tso zis tawm. Empagliflozin yog thawj cov tshuaj tiv thaiv kab mob ntshav qab zib tau pom zoo los ntawm Tebchaws Meskas thiab European Union kom txo qis kev pheej hmoo ntawm cov hlab plawv (CV) tuag rau cov neeg laus uas muaj hom 2 mob ntshav qab zib mellitus. Nws kuj tau raug pom zoo raws li kev kho mob rau tag nrho cov neeg laus cov neeg mob uas muaj cov tsos mob ntawm lub plawv tsis ua hauj lwm, nrog rau cov neeg mob uas muaj tag nrho cov hom ntawm sab laug ventricular ejection feem (LVEF), uas yog lub plawv tsis ua hauj lwm nrog txo ejection feem (HFrEF) thiab lub plawv tsis ua hauj lwm nrog khaws cia ejection feem (HFpEF).
Thawj qhov kev tshawb fawb thiab kev loj hlob tuam txhab ntawm Empagliflozin yog Boehringer Ingelheim. Cov ntsiav tshuaj Empagliflozin tau pom zoo rau kev lag luam hauv Tebchaws Meskas hauv xyoo 2014 thiab hauv Suav teb xyoo 2017. Raws li Minenet database, cov khoom muag hauv tsev ntawm empagliflozin ntsiav tshuaj tau txog li RMB 571 lab hauv 2022. Tam sim no, APIs ntawm empagliflozin uas tsim los ntawm 17 cov chaw tsim tshuaj hauv tsev Zheji tau pom zoo rau kev lag luam tshuaj siv hauv Huajia, nrog rau cov kev npaj siv tshuaj hauv Huajhai. Co., Ltd., Sichuan Kelun Pharmaceutical Co., Ltd., Jiangsu Hansoh Pharmaceutical Group Co., Ltd., Yangzijiang Pharmaceutical Group Co., Ltd. thiab Lianyungang Recbio Pharmaceutical Co., Ltd.
Thaum lub Cuaj Hlis 2022, Changhai Pharmaceutical tau xa daim ntawv teev npe thiab kev lag luam rau API rau NMPA, uas tau txais. Txog rau tam sim no, Lub Tuam Txhab tau nqis peev tag nrho kwv yees li RMB 26.1752 lab hauv kev tshawb fawb thiab kev tsim kho cov nuj nqis rau empagliflozin API qhov project.
