Thaum Lub Xya Hli 11, 2023, Hybio Pharmaceutical (Wuhan) Co., Ltd. (tom ntej no hu ua "Hybio Wuhan"), ib tug nkaus -tus tswv lag luam ntawm Shenzhen Hybio Pharmaceutical Co., Ltd. (tom qab no hu ua "Lub Tuam Txhab"), tau txais "Hybio Pharmaceutical".Daim Ntawv Ceeb Toom Pom Zoo rau Kev Ua Lag Luam Kev Siv Tshuaj Siv Tshuaj Muaj Tshuaj(Acceptance No.: CYHS2260223) muab los ntawm National Medical Products Administration (NMPA) rau nws Cetrorelix Acetate API, thiab cov ntaub ntawv cuam tshuam tau tshaj tawm rau hauv lub vev xaib raug cai ntawm Lub Chaw Saib Xyuas Tshuaj Ntsuam Xyuas Tshuaj (CDE) hauv qab NMPA. Peb tshaj tawm cov ntsiab lus tseem ceeb raws li hauv qab no:
I. Cov ntaub ntawv sau npe ntawm API
Lub Npe Lub Npe: Cetrorelix Acetate
Nr.: Y20220000234
Ntim Cov Lus Qhia: 1g / hnab; 2 g / hnab; 5 g / hnab; 10g / hnab; 15g / hnab; 20g / hnab; 50g / hnab
Chaw tsim tshuaj paus: Hybio Pharmaceutical (Wuhan) Co., Ltd.
Daim Ntawv Thov: Daim ntawv thov kev lag luam rau cov khoom siv tshuaj API hauv tsev thiab kev tshuaj xyuas sib koom nrog nws cov ntawv ua tiav
Cov txiaj ntsig: A (pom zoo rau kev siv hauv kev lag luam ua tiav cov ntawv ua tiav)
II. Lwm Cov Lus Qhia Txog Tshuaj
Cetrorelix Acetate yog ib qho khoom siv decapeptide, uas nws daim ntawv noj tshuaj tiav yog ib qho tshuaj gonadotropin - tso tawm cov tshuaj hormone (GnRH) antagonist, qhia txog kev pabcuam kev loj hlob thiab inhibition ntawm ntxov ntxov luteinizing hormone (LH) surge.
