Tofacitinib citrate waa dawo dhakhtar soo qoray (magaca ganacsiga Xeljanz) oo asal ahaan ay samaysay Pfizer fasalka ka hortagga Janus kinase (JAK). Waxay si xushmad leh u joojin kartaa JAK kinase, waxay xannibi kartaa dariiqyada JAK/STAT, waxayna joojinaysaa is-beddelka unugyada iyo muujinta hidda-wadaha la xidhiidha iyo firfircoonida, oo loo isticmaalo daaweynta rheumatoid arthritis-ka, psoriatic arthritis, ulcerative colitis iyo cudurrada kale ee difaaca.
Daawadu waxay ka kooban tahay saddex nooc oo qiyaas ah: kiniinno, kiniinno sii-daynta joogtada ah iyo xalalka afka ah. Kiniinadeeda waxaa markii ugu horeysay ansixisay FDA 2012, iyo foomka qiyaasta sii deynta joogtada ah waxaa ansixiyay FDA bishii Febraayo 2016. Waa markii ugu horeysay ee lagu daweeyo kala-goysyada rheumatoid. Yan waa daawada JAK ee afka laga qaato hal mar maalintii. Bishii Disembar 2019, tilmaan cusub oo dawooyinka sii-daynta joogtada ah ayaa mar labaad loo oggolaaday dhexdhexaadka ama daran xanuunka boogaha firfircoon (UC). Intaa waxaa dheer, marxaladda hadda jirta ee 3 ee tijaabooyinka bukaan-socodka ee cudurka psoriasis ee xuubka ayaa la dhammeeyey, lix weji oo kale 3 tijaabo caafimaad ayaa socda, kuwaas oo ku lug leh psoriatic arthritis-ka firfircoon, ilmo-galeenka idiopathic arthritis-ka, iwm. Nooca calaamadaha. Faa'iidooyinka kiniinnada sii-daynta joogtada ah ee muddada dheer shaqeynaya una baahan in la qaato hal mar oo keliya maalintii ayaa waxtar u leh maaraynta iyo xakamaynta cudurrada bukaanka.
Tan iyo liiskeeda, iibkeeda ayaa kordhay sanadba sanadka ka dambeeya, isagoo gaaray US $ 2.242 ee 2019. Shiinaha, foomka qiyaasta kiniiniga waxaa loo ansixiyay suuq-geynta bishii Maarso 2017, waxayna gashay qaybta caymiska caafimaadka ee B iyada oo loo marayo wadahadal 2019. Guulihii ugu dambeeyay wuxuu ahaa 26.79 RMB. Si kastaba ha ahaatee, sababtoo ah caqabadaha sare ee farsamada ee diyaargarowga sii-deynta joogtada ah, foomkan qiyaasta weli lama suuq geyn Shiinaha.
JAK kinase waxay door muhiim ah ka ciyaartaa caabuqa, iyo inhibitiyayaashiisa ayaa la muujiyay inay daaweeyaan cudurada bararka iyo difaaca jirka qaarkood. Ilaa hadda, 7 JAK inhibitors ayaa la ansixiyay si caalami ah, oo ay ku jiraan Leo Pharma's Delgocitinib, Celgene's Fedratinib, AbbVie's upatinib, Astellas's Pefitinib, Eli Lilly's Baritinib iyo Novartis's Rocotinib. Si kastaba ha ahaatee, kaliya tofacitinib, baritinib iyo rocotinib ayaa laga ansixiyay Shiinaha oo ka mid ah daawooyinka kor ku xusan. Waxaan rajaynaynaa in Qilu's "Tofatib Citrate Sustained Release Tablets" la ansixiyo sida ugu dhaqsaha badan oo uu uga faa'iidaysto bukaanno badan.
Shiinaha, cilmi-baarista asalka ah ee tofacitib citrate waxaa ansixiyay NMPA bishii Maarso 2017 si loogu daweeyo bukaannada RA ee qaangaarka ah oo aan ku filneyn ama u dulqaadan karin methotrexate, oo hoos yimaada magaca ganacsiga Shangjie. Sida laga soo xigtay xogta Meinenet, iibinta kiniiniyada citrate tofacitib ee xarumaha caafimaadka dadweynaha ee Shiinaha ee 2018 waxay ahaayeen 8.34 milyan yuan, taas oo aad uga hooseysa iibka caalamiga ah. Qayb weyn oo ka mid ah sababta waa qiimaha. Waxaa la sheegay in Shangjie qiimihiisii tafaariiqda ee bilowga ahaa uu ahaa 2085 yuan (5mg*28 kaniini), qarashka bishiina uu ahaa 4170 yuan, taas oo aan culeys yar ku ahayn qoysaska caadiga ah.
Si kastaba ha ahaatee, waxaa mudan in la dabaaldego in tofacitib lagu daray 2019 "Caymiska Caafimaadka Aasaasiga ah ee Qaranka, Caymiska Dhaawaca Shaqada iyo Liiska Dawooyinka Caymiska Hooyada" ee Maamulka Caymiska Caafimaadka Qaranka ka dib wada xaajoodka Noofambar 2019. Waxaa la sheegay in kharashka bishii la dhimi doono. ilaa 2,000 yuan ka dib marka qiimaha la dhimo laga wada xaajoodo, taas oo si weyn u wanaajin doonta helitaanka daawada.
Bishii Agoosto 2018, Guddiga Dib-u-eegista Patent ee Xafiiska Hanti-Garaadka ee Gobolka ayaa sameeyay go'aan dib u eegis lambar 36902 codsi burinaya, waxayna caddeeyeen in aanay ansax ahayn rukhsadda asaasiga ah ee Pfizertofatib, patent-ka dhismaha, sababo la xiriira siidaynta ku filan ee qeexitaanka. Si kastaba ha ahaatee, shatiga shatiga Pfizertofatiib qaabka crystal (ZL02823587.8, CN1325498C, taariikhda codsiga 2002.11.25) wuxuu dhacayaa 2022.
Xogta Insight waxay muujinaysaa in, marka lagu daro cilmi-baadhistii asalka ahayd, shan dawooyin guud oo Chia Tai Tianqing, Qilu, Kelun, Yangtze River, iyo Nanjing Chia Tai Tianqing loo oggolaaday suuq-geynta qaababka kiniinka tofacitinib ee gudaha. Si kastaba ha ahaatee, nooca kiniiniga sii-daynta joogtada ah, kaliya cilmi-baadhistii asalka ahayd ee Pfizer ayaa soo gudbisay arji suuq-geyneed Maajo 26. Qilu waa shirkaddii ugu horreysay ee gudaha ah oo soo gudbisa arjiga suuq-geynta ee qaabayntan. Intaa waxaa dheer, CSPC Ouyi waxay ku jirtaa marxaladda tijaabada BE.
Warshada Dawooyinka ee Changzhou (CPF) waa hormuudka soo saaraha dawooyinka ee API-yada, qaabaynta ku dhammaatay Shiinaha, taas oo ku taal Changzhou, gobolka Jiangsu. CPF waxaa la aasaasay 1949. Waxaan u hurnay Tofacitinib Citrate laga bilaabo 2013, oo aan horay u gudbinay DMF. Waxaan ka diiwaan gashannay wadamo badan, waxaanan ku taageeri karnaa dukumeentiyada ugu fiican ee taageerada Tofacitinib Citrate.
Waqtiga boostada: Jul-23-2021