Tofacitinib citrate ni imiti yandikiwe (izina ryubucuruzi Xeljanz) yabanje gukorwa na Pfizer kumurwi wa Janus kinase (JAK) inhibitor. Irashobora guhitamo guhitamo JAK kinase, guhagarika inzira za JAK / STAT, bityo bikabuza kwanduza ibimenyetso byingirabuzimafatizo hamwe no kwerekana imiterere ya gene hamwe nogukora, bikoreshwa mukuvura rubagimpande ya rubagimpande, arthrite ya psoriatique, colitis ibisebe nizindi ndwara.

Umuti urimo uburyo butatu bwa dosiye: ibinini, ibinini bisohora-ibisubizo hamwe nibisubizo byo munwa. Ibinini byayo byemejwe bwa mbere na FDA mu mwaka wa 2012, kandi ifishi ya dosiye irekura-yemejwe na FDA muri Gashyantare 2016. Ni yo ya mbere ivura ingingo za rubagimpande. Yan ni inhibitor ya JAK ifatwa kumanwa rimwe kumunsi. Ukuboza 2019, ikimenyetso gishya cy’imiti irekura-yongeye kwemezwa na kanseri yanduye kandi ikabije (UC). Byongeye kandi, icyiciro cya 3 cyamavuriro yubuvuzi bwa plaque psoriasis cyararangiye, kandi andi manza atandatu yicyiciro cya 3 yubuvuzi arakomeje, arimo arthrite ikora psoriatic, arthritis idiopathic arthritis, nibindi. Ibyiza bya tableti irekura-irekura ikora kandi ikenera gufatwa rimwe kumunsi bifasha gucunga 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 rwa tablet rwemejwe ko rwamamazwa muri Werurwe 2017, kandi rwinjira mu cyiciro cy’ubwishingizi bw’ubuvuzi B binyuze mu mishyikirano muri 2019. Iheruka gutsinda isoko ni amafaranga 26.79. Ariko, kubera inzitizi zikomeye za tekiniki zo kwitegura-kurekura, iyi fomu ya dosiye ntirashyirwa ku isoko mu Bushinwa.

JAK kinase igira uruhare runini mu gutwika, kandi ibiyibuza byagaragaye ko bivura 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 bishoboka 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 budahagije cyangwa kutihanganira methotrexate, ku izina ry’ubucuruzi Shangjie. Amakuru aturuka muri 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.

Icyakora, birakwiye ko twishimira ko tofacitib yashyizwe muri “Ubwishingizi bw’ubuvuzi bw’ibanze mu mwaka wa 2019, Ubwishingizi bw’imvune ku kazi n’ubwishingizi bw’ibiyobyabwenge by’ababyeyi” n’ikigo cy’igihugu gishinzwe ubwishingizi bw’ubuvuzi nyuma y’imishyikirano mu Gushyingo 2019. Biravugwa ko amafaranga y’ukwezi azagabanuka. kugeza munsi ya 2000 Yuan nyuma yo kugabanura ibiciro byumvikanyweho, bizamura cyane imiti iboneka.

Muri Kanama 2018, Ikigo gishinzwe isuzuma ry’ipatanti ry’ibiro bya Leta bishinzwe umutungo bwite mu by'ubwenge cyafashe icyemezo cyo gusuzuma No 36902 gisaba guteshwa agaciro, kandi gitangaza ko kidafite ishingiro ipatanti shingiro ya Pfizertofatib, ipatanti y’uruvange, 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 bw’umwimerere, imiti itanu rusange ya Chia Tai Tianqing, Qilu, Kelun, Umugezi wa Yangtze, na Nanjing Chia Tai Tianqing yemerewe gucuruzwa mu bikoresho bya tofacitinib byo mu rugo. Nyamara, kubwoko bwa tablet burambye-busohora, gusa ubushakashatsi bwambere Pfizer bwatanze 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 BE.

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