I-Changzhou Pharmaceutical Factory Ltd.,inkampani ephethwe yi-Shanghai Pharmaceutical Holdings, ithole Isitifiketi Sokubhaliswa Kwezidakamizwa (Isitifiketi No. 2021S01077, 2021S01078, 2021S01079) esikhishwe i-State Drug Administration forI-Lenalidomide Capsules(Ukucaciswa kwe-5mg, 10mg, 25mg), okugunyazwe ukukhiqizwa.
Ulwazi oluyisisekelo
Igama lesidakamizwa:I-Lenalidomide capsules
Ifomu lomthamo:I-Capsule
Ukucaciswa:5mg, 10mg, 25mg
Ukubhaliswa ngezigaba:Isigaba 4 semithi yamakhemikhali
Inombolo yeqoqo:Isitifiketi Sezidakamizwa Sikahulumeni H20213802, Isitifiketi Sezidakamizwa Sikahulumeni H20213803, Isitifiketi Sezidakamizwa Sikahulumeni H20213804
Isiphetho sokugunyazwa: Hlangana nezidingo zokubhaliswa kwezidakamizwa, okugunyazwe ukubhaliswa, kukhishwe isitifiketi sokubhaliswa kwezidakamizwa.
Ulwazi oluhlobene
Lenalidomideiyisizukulwane esisha somuthi womlomo ovimbela ukuzivikela komzimba onomsebenzi wokuvimbela ukwanda kwamangqamuzana e-tumor, okwenza i-tumor cell apoptosis kanye ne-immunomodulation, esetshenziswa kakhulu ekwelapheni i-myeloma eminingi kanye ne-myelodysplastic syndrome (MDS) nezinye izimo.Isetshenziswa ngokuhambisana ne-dexamethasone ukwelapha iziguli ezikhulile ezine-myeloma eminingi engazange ilashwe ngaphambili ezingakhethwanga ekufakelweni kabusha.Lo mkhiqizo usetshenziswa ngokuhambisana ne-dexamethasone ukwelapha iziguli ezindala ezine-myeloma eminingi ezithole okungenani ukwelashwa okukodwa kwangaphambili.Lo mkhiqizo usetshenziswa ngokuhambisana ne-rituximab ukwelapha iziguli ezindala ezine-follicular lymphoma (amabanga 1-3a) ezithole ukwelashwa kwangaphambili.
Amaphilisi e-Lenalidomide athuthukiswa okokuqala yi-Celgene Biopharmaceuticals futhi adayiswa e-US ngo-2005. ngo-December 2019, i-Changzhou Pharmaceutical Factory yafaka isicelo sokubhalisa nokumaketha ku-State Drug Administration somuthi, esamukelwe.
Idatha evela ku-Minene.com ibonisa ukuthi ukuthengiswa kukazwelonke kwamaphilisi e-Nalidomide ngo-2020 kuzoba cishe i-RMB 1.025 billion.
Ngokwezinqubomgomo zikazwelonke ezifanele, izinhlobo zemithi ejwayelekile egunyazwe ngokuya ngesigaba esisha sokubhaliswa zizothola ukwesekwa okukhulu ezindaweni ezifana nenkokhelo yomshwalense wezokwelapha kanye nokuthengwa kwezikhungo zezokwelapha.Ngakho-ke, ukukhiqizwa okugunyaziwe kweI-Changzhou Pharmaceutical Factory's lenalidomidei-capsule ikulungele ukuqhubekisela phambili ukwandisa isabelo sayo semakethe emkhakheni wokwelashwa kwe-hematology-isimila kanye nokuthuthukisa ukuncintisana kwayo ezimakethe, kanye nokuqongelela ulwazi olubalulekile lwemikhiqizo elandelayo yenkampani ukuze yenze ukuthuthukiswa kwezidakamizwa ezijwayelekile kanye nokubhaliswa kokubhaliswa.