Tsis ntev los no, Hefei Lifang Pharmaceutical Co., Ltd. (tom qab no hu ua "Company" lossis "Lifang Pharmaceutical") tau txais "Acceptance Notification" los ntawm National Medical Products Administration (NMPA) rau Daim Ntawv Tso Cai Ua Lag Luam (MAA) ntawm Relugolix Active Pharmaceutical Ingredient (API). Cov ntsiab lus tseem ceeb tau tshaj tawm hauv qab no:
I. Cov ntsiab lus tseem ceeb ntawm "Kev Ceeb Toom Txais"
Daim Ntawv Thov: Kev Tso Cai Ua Lag Luam
Khoom npe: Relugolix
Kev piav qhia Kev lees txais: Raws li cov kev cai ntawm Tshooj 32 ntawm lubTxoj Cai Tswjfwm Ntiag Tug ntawm Tuam Txhab Tuam Txhab Tuam Tshoj, tom qab tshuaj xyuas, nws tau txiav txim siab lees txais daim ntawv thov.
Tus Naj Npawb: Y20240001454 (Acceptance Number: CXHS2560***)
II. Cov ntaub ntawv ntsig txog Relugolix
Relugolix yog qhov ncauj gonadotropin - tso cov tshuaj hormone (GnRH) receptor antagonist. Nws tuaj yeem cuam tshuam cov synthesis thiab tso tawm ntawm gonadotropins xws li luteinizing hormone (LH) thiab follicle-stimulating hormone (FSH), txo cov qib ntawm cov tshuaj hormones xws li testosterone thiab estradiol, thiab siv rau kev kho cov tshuaj hormone-nyob ntawm cov kab mob xws li endometriosis, uterine fibroids, thiab prostate. mob qog noj ntshav. Daim ntawv thov no yog rau cov tshuaj API siv hauv kev tsim cov tshuaj uas tseem tsis tau ua lag luam hauv Suav teb. Raws li hnub tshaj tawm no, tsis muaj cov kev npaj tshuaj cuam tshuam tau pom zoo rau kev lag luam hauv Suav teb. Ntxiv rau Lub Tuam Txhab, 10 lub tuam txhab tau ua tiav kev sau npe thiab ua tiav rau API no, nrog rau tag nrho cov ntawv sau npe cim npe "I" (API / excipient / pob khoom tseem tsis tau dhau qhov kev tshuaj xyuas thiab kev pom zoo nrog kev npaj).
