Changzhou Pharmaceutical Factory Ltd.,i-subsidiary ye-Shanghai Pharmaceutical Holdings, ifumene iSatifikethi sokuBhalisa iChiza (iSitifiketi esinguNombolo 2021S01077, 2021S01078, 2021S01079) esikhutshwe nguRhulumente woLawulo lweDrugsIipilisi zeLenalidomide(Inkcazo ye-5mg, i-10mg, i-25mg), eyavunywa ukuveliswa.
Ulwazi olusisiseko
Igama lechiza:Iipilisi zeLenalidomide
Ifomu yomthamo:I-Capsule
Inkcazo:5mg, 10mg, 25mg
Ukuhlelwa kobhaliso:Udidi lwesi-4 lwamachiza ekhemikhali
Inombolo yebhetshi:ISatifikethi soMbuso seDrugs H20213802, iSatifikethi soMbuso seDrugs H20213803, iSatifikethi soMbuso seDrugs H20213804
Isiphelo sokuvunywa: Ukuhlangabezana neemfuno zobhaliso lwamachiza, oluvunyiweyo ukubhaliswa, lukhuphe isatifikethi sokubhaliswa kwechiza.
Ulwazi olunxulumeneyo
Lenalidomidesisizukulwana esitsha seziyobisi zomlomo ezikhusela umzimba kunye nomsebenzi wokuthintela ukwanda kweeseli zethumba, ukubangela i-apoptosis yeseli ye-tumor kunye ne-immunomodulation, esetyenziswa kakhulu kunyango lwe-myeloma emininzi kunye ne-myelodysplastic syndrome (MDS) kunye nezinye iimeko. Isetyenziswa ngokudityaniswa ne-dexamethasone ukunyanga izigulane zabantu abadala ezine-myeloma ezininzi ezazinganyangwa ngaphambili ezingabaviwa bokufakelwa. Le mveliso isetyenziswa ngokudibeneyo ne-dexamethasone ukunyanga izigulane zabantu abadala abane-myeloma ezininzi ezifumene ubuncinane unyango olunye lwangaphambili. Le mveliso isetyenziselwa ukudibanisa ne-rituximab ukunyanga izigulane zabantu abadala abane-follicular lymphoma (amabanga 1-3a) abaye bafumana unyango lwangaphambili.
I-capsules ye-Lenalidomide yaqala ukuphuhliswa yi-Celgene Biopharmaceuticals kwaye yathengiswa e-US ngo-2005. ngoDisemba 2019, i-Changzhou Pharmaceutical Factory yafaka isicelo sokubhalisa kunye nokuthengisa kunye noLawulo lweZidakamizwa kaRhulumente lwechiza, olwamkelwa.
Idatha evela kwi-Minene.com ibonisa ukuba ukuthengiswa kwelizwe le-Nalidomide capsules kwi-2020 kuya kuba malunga ne-RMB 1.025 billion.
Ngokwemigaqo-nkqubo yesizwe echaphazelekayo, iintlobo zamachiza enziwe afana nalawo enziwe afana nalawo aveliswe ngabenzi amkelwe ngokohlelo olutsha lobhaliso ziya kufumana inkxaso enkulu kwimimandla efana nentlawulo ye-inshorensi yonyango kunye nokuthengwa kweziko lonyango. Ngoko ke, imveliso evunyiweyo yeChangzhou Pharmaceutical Factory's lenalidomideI-capsule ilungele ukwandisa ngakumbi isabelo sayo semarike kwicandelo lonyango lwe-hematology-ithumba kunye nokuphucula ukukhuphisana kwayo kwimarike, kunye nokuqokelela amava axabisekileyo kwiimveliso ezilandelayo zenkampani ukwenza uphuhliso lwamachiza enziwe afana nalawo aveliswe ngumenzi kunye nokubhaliswa kobhaliso.