Tofacitinib Citrate

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Tofacitinib citrate ni imiti yandikiwe (izina ryubucuruzi Xeljanz) yatunganijwe mbere na Pfizer kumurongo wa Janus kinase yo mu kanwa (JAK).Irashobora guhitamo guhagarika JAK kinase, guhagarika inzira ya JAK / STAT, bityo ikabuza kwanduza ibimenyetso bya selile hamwe no kwerekana imiterere ya gene hamwe no gukora, ikoreshwa mukuvura rubagimpande ya rubagimpande, arthritis psoriatic, colitis ulcerative nizindi ndwara zubudahangarwa.

Ibiyobyabwenge birimo dosiye eshatu: ibinini, ibinini bisohora-ibisubizo hamwe nibisubizo byo munwa.Ibinini byayo byemejwe bwa mbere na FDA muri 2012, kandi ifishi ihoraho-irekurwa yemejwe na FDA muri Gashyantare 2016. Nibwo bwa mbere buvura ingingo za rubagimpande.Yan ni JAK inhibitor ifatwa kumanwa rimwe kumunsi.Ukuboza 2019, ikimenyetso gishya cy’imiti irekura-yongeye kwemezwa kuri kolite ikabije kandi ikabije (UC).Byongeye kandi, icyiciro cya 3 cyamavuriro yubuvuzi bwa plaque psoriasis cyararangiye, naho andi masomo atandatu yicyiciro cya 3 arakomeje, arimo arthrite ikora psoriatic, arthritis idiopathic arthritis, nibindi.Ibyiza byibinini bisohora-birebire kandi bigomba gufatwa rimwe kumunsi bifasha mugucunga no kugenzura indwara zabarwayi.

Kuva yashyizwe ku rutonde, ibicuruzwa byayo byiyongereye uko umwaka utashye, bigera kuri miliyari 2.242 z'amadolari ya Amerika muri 2019. Mu Bushinwa, urupapuro rwa dosiye rwemewe rwo kwamamaza muri Werurwe 2017, kandi rwinjira mu cyiciro cy’ubwishingizi bw’ubuvuzi B binyuze mu mishyikirano muri 2019. Intsinzi iheruka ipiganwa ni amafaranga 26.79.Ariko, kubera inzitizi zikomeye za tekiniki zo kwitegura-kurekura, iyi fomu ya dosiye ntabwo igurishwa mubushinwa.

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JAK kinase igira uruhare runini mugutwika, kandi inhibitor zayo zivura indwara zimwe na zimwe ziterwa na autoimmune.Kugeza ubu, inzitizi 7 za JAK zemewe ku isi hose, harimo Delgocitinib ya Leo Pharma, Fedratinib ya Celgene, upatinib ya AbbVie, Pefitinib ya Astellas, Baritinib ya Eli Lilly na Rocotinib ya Novartis.Nyamara, tofacitinib, baritinib na rocotinib byemewe mu Bushinwa mu biyobyabwenge byavuzwe haruguru.Dutegereje ko Qilu “Tofatib Citrate Sustained Release Tablets” yemerwa vuba kandi ikagirira akamaro abarwayi benshi.

Mu Bushinwa, ubushakashatsi bw’umwimerere tofacitib citrate bwemejwe na NMPA muri Werurwe 2017 kugira ngo buvure abarwayi ba RA bakuze bafite ubushobozi buke cyangwa kutihanganira methotrexate, ku izina ry’ubucuruzi Shangjie.Amakuru dukesha Meinenet avuga ko mu mwaka wa 2018 igurishwa ry’ibinini bya tofacitib citrate mu bigo by’ubuvuzi bya Leta by’Ubushinwa byari miliyoni 8.34, bikaba byari munsi y’igurishwa ry’isi yose.Igice kinini cyimpamvu nigiciro.Biravugwa ko igiciro cya mbere cya Shangjie cyagurishijwe cyari 2085 (ibinini 5mg * 28), naho ikiguzi cya buri kwezi cyari 4170, ntabwo ari umutwaro muto ku miryango isanzwe.

Ariko rero, birakwiye ko twishimira ko tofacitib yashyizwe muri 2019 "Ubwishingizi bwibanze bwubuvuzi bwigihugu, Ubwishingizi bw’imvune ku kazi n’ubwishingizi bw’imiti y’ababyeyi" n’ikigo cy’igihugu gishinzwe ubwishingizi bw’ubuvuzi nyuma y’imishyikirano mu Gushyingo 2019. Biravugwa ko amafaranga y’ukwezi azagabanuka. kugeza munsi yama 2000 nyuma yo kugabanya ibiciro byumvikanyweho, bizamura cyane imiti iboneka.

Muri Kanama 2018, Ikigo cy’igihugu gishinzwe umutungo bwite mu by'ubwenge cyafashe icyemezo cyo gusuzuma No 36902 gisaba guteshwa agaciro, kandi gitangaza ko kidafite ishingiro ipatanti y’ibanze ya Pfizertofatib, ipatanti y’ibihimbano, bitewe n’uko nta bisobanuro byatanzwe bihagije.Ariko, ipatanti yuburyo bwa kristu ya Pfizertofatiib (ZL02823587.8, CN1325498C, itariki yo gusaba 2002.11.25) izarangira muri 2022.

Ububiko bwa Insight bwerekana ko, usibye ubushakashatsi bwambere, imiti itanu rusange ya Chia Tai Tianqing, Qilu, Kelun, Yangtze River, na Nanjing Chia Tai Tianqing yemerewe gucuruzwa mububiko bwa tofacitinib.Ariko, kubwoko bwa tablet burambye-burekura, gusa ubushakashatsi bwambere Pfizer yatanze icyifuzo cyo kwamamaza ku ya 26 Gicurasi. Qilu nisosiyete yambere yo murugo yatanze ibyifuzo byo kwamamaza kuriyi formulaire.Mubyongeyeho, CSPC Ouyi iri murwego rwo kugerageza.

Uruganda rukora imiti ya Changzhou (CPF) n’uruganda rukora imiti rukora imiti ya API, rwarangije gukora mu Bushinwa, ruherereye i Changzhou, intara ya Jiangsu.CPF yashinzwe mu 1949. Twiyeguriye Citrate ya Tofacitinib kuva 2013, tunatanga DMF.Twiyandikishije mubihugu byinshi, kandi dushobora kugutera inkunga hamwe ninyandiko nziza zishyigikira Citrate ya Tofacitinib.


Igihe cyo kohereza: Jul-23-2021