Tofacitinib Citrate

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Tofacitinib citrate imishonga yemishonga (zita rekutengeserana Xeljanz) yakatanga kugadzirwa nePfizer yekirasi ye oral Janus kinase (JAK) inhibitors.Inogona kurambidza JAK kinase, kuvharira JAK / STAT nzira, uye nekudaro inhibisa cell sign transduction uye Related gene expression uye activation, inoshandiswa kurapa rheumatoid arthritis, psoriatic arthritis, ulcerative colitis uye zvimwe zvirwere zvekudzivirira muviri.

Mushonga uyu unosanganisira mafomu matatu emushonga: mahwendefa, mahwendefa anoramba achiburitswa uye mhinduro dzemuromo.Mahwendefa ayo akatanga kutenderwa neFDA muna 2012, uye fomu yepimodhi yakaramba ichiburitswa yakabvumidzwa neFDA muna Kukadzi 2016. Ndiyo yekutanga kurapa majoini erheumatoid.Yan inhibitor yeJAK inotorwa nemuromo kamwe chete pazuva.Muna Zvita 2019, chiratidzo chitsva chemishonga yakaramba ichiburitswa yakabvumidzwa zvakare kune pakati nepakati kusvika kune yakanyanya active ulcerative colitis (UC).Mukuwedzera, ikozvino chikamu chechitatu chekliniki miedzo ye plaque psoriasis yakapedzwa, uye imwe nhanhatu nhanhatu 3 miedzo yekliniki iri kuenderera mberi, inosanganisira inoshanda psoriatic arthritis, juvenile idiopathic arthritis, etc. Rudzi rwezviratidzo.Zvakanakira zvemapiritsi anogara achiburitswa anogara kwenguva refu uye anongoda kutorwa kamwe chete pazuva anobatsira pakutarisira nekudzora zvirwere zvevarwere.

Kubva payakanyorwa, kutengesa kwayo kwakawedzera gore negore, kusvika US$2.242 bhiriyoni muna 2019. KuChina, fomu repiritsi remushonga rakatenderwa kutengeswa muna Kurume 2017, uye rakapinda muboka reinishuwarenzi yekurapa reboka B kuburikidza nenhaurirano muna 2019. mutengo wayo iRMB 26.79.Nekudaro, nekuda kweiyo yakakwira tekinoroji zvipingamupinyi zvekugadzirira-kuburitswa-kuburitswa, iyi fomu reyero haisati yatengeswa muChina.

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JAK kinase inoita basa rakakosha mukuzvimba, uye inhibitors yayo yakaratidzwa kurapa zvimwe zvirwere zvinozvimba uye autoimmune.Kusvika zvino, 7 JAK inhibitors yakabvumidzwa pasi rose, kusanganisira Leo Pharma's Delgocitinib, Celgene's Fedratinib, AbbVie's upatinib, Astellas's Pefitinib, Eli Lilly's Baritinib Uye Novartis's Rocotinib.Zvisinei, chete tofacitinib, baritinib uye rocotinib inobvumirwa muChina pakati pemishonga yataurwa pamusoro apa.Tinotarisira kuti Qilu's "Tofatib Citrate Sustained Release Tablets" ichitenderwa nekukasika uye kubatsira varwere vakawanda.

MuChina, tsvakiridzo yepakutanga tofacitib citrate yakabvumidzwa neNMPA munaKurume 2017 kuitira kurapwa kwevakuru veRA varwere vasina kukwana kana kusashivirira methotrexate, pasi pezita rekutengesa Shangjie.Zvinoenderana nedata kubva kuMeinenet, kutengeswa kwemapiritsi etofacitib citrate muzvipatara zveveruzhinji zveChina muna 2018 aive 8.34 miriyoni yuan, iyo yaive yakaderera zvakanyanya kupfuura kutengesa kwayo kwepasirese.Chikamu chikuru chechikonzero mutengo.Zvinonzi mutengo wekutanga waShangjie wekutengesa waive 2085 yuan (5mg*28 mapiritsi), uye mutengo wepamwedzi waive 4170 yuan, usiri mutoro mudiki kumhuri dzakajairwa.

Nekudaro, zvakakosha kupemberera kuti tofacitib yakabatanidzwa mu2019 "National Basic Medical Insurance, Work Injury Insurance uye Maternity Insurance Drug List" neNational Medical Insurance Administration mushure menhaurirano muna Mbudzi 2019. Zvinonzi mari yepamwedzi ichaderedzwa. kusvika pasi pe2,000 yuan mushure mekunge mutengo waderedzwa, izvo zvichavandudza zvikuru kuwanikwa kwemushonga.

Muna Nyamavhuvhu 2018, Patent Reexamination Board yeState Intellectual Property Office yakaita sarudzo yekuongorora Nha. 36902 chikumbiro chekusashanda, uye yakazivisa kuti iyo yakakosha patent yePfizertofatib, iyo komputa patent, nekuda kwekusakwana kuburitswa kweiyo yakatarwa.Nekudaro, iyo patent yePfizertofatiib crystal fomu (ZL02823587.8, CN1325498C, zuva rekushandisa 2002.11.25) ichapera muna 2022.

Iyo Insight dhatabhesi inoratidza kuti, pamusoro pekutsvagisa kwekutanga, mishonga mishanu yegeneric yeChia Tai Tianqing, Qilu, Kelun, Yangtze River, uye Nanjing Chia Tai Tianqing yakabvumidzwa kushambadzira mukugadzirwa kwepiritsi yetofacitinib.Nekudaro, kune yakaramba-yakaburitswa piritsi yemhando, iyo yekutanga tsvakiridzo Pfizer chete yakatumira chikumbiro chekushambadzira muna Chivabvu 26. Qilu ndiyo yekutanga kambani yepamba kutumira chikumbiro chekushambadzira kwechigadzirwa ichi.Pamusoro pezvo, CSPC Ouyi iri muchikamu cheBE chekuedza.

Changzhou Pharmaceutical Factory (CPF) inotungamira mishonga yekugadzira mishonga yeAPIs, yakapera maumbirwo muChina, iri muChangzhou, mudunhu reJiangsu.CPF yakavambwa muna 1949. Isu takazvipira muTofacitinib Citrate kubva ku2013, uye takaendesa DMF kare.Isu takanyoresa munyika dzakawanda, uye tinogona kukutsigira nemagwaro akanakisa ekutsigira Tofacitinib Citrate.


Nguva yekutumira: Jul-23-2021