Tofacitinib citrate imishonga yemishonga (zita rekutengeserana Xeljanz) yakatanga kugadzirwa naPfizer yekirasi ye oral Janus kinase (JAK) inhibitors. Inogona kuvharidzira JAK kinase, kuvharira JAK / STAT nzira, uye nekudaro inhibit cell signal 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 rheumatoid joints. 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 chekuedza kwekliniki 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, kunosvika US$2.242 bhiriyoni muna 2019. MuChina, fomu repiritsi remushonga rakatenderwa kutengeswa muna Kurume 2017, uye rakapinda muboka reinishuwarenzi yezvokurapa reboka B kuburikidza nenhaurirano muna 2019. mutengo wayo iRMB 26.79. Nekudaro, nekuda kweakakwira tekinoroji zvipingamupinyi zvekugadzirira-kuburitswa-kuburitswa, iyi fomu yedosi haisati yatengeswa muChina.

JAK kinase inoita basa rakakosha mukuzvimba, uye inhibitors yayo yakaratidzwa kurapa zvimwe zvirwere zvinoputika uye autoimmune. Kusvika parizvino, 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 zvinotenderwa muChina pakati pemishonga yataurwa pamusoro apa. Tinotarisira kuti Qilu's "Tofatib Citrate Sustained Release Tablets" ichatenderwa nekukasira 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. Nekudaro, iyo patent yePfizertofatiib crystal fomu (ZL02823587.8, CN1325498C, zuva rekushandisa 2002.11.25) ichapera muna 2022.

Dhatabhesi reInsight rinoratidza kuti, pamusoro pekutsvagisa kwekutanga, mishonga mishanu yegeneric yeChia Tai Tianqing, Qilu, Kelun, Yangtze River, uye Nanjing Chia Tai Tianqing yakabvumidzwa kushambadzira mukugadzirwa kwepiritsi refacitinib. Zvisinei, nokuda kwemhando yepiritsi yakaramba ichisunungurwa, chete tsvakurudzo yepakutanga Pfizer yakatumira chikumbiro chekutengesa musi waMay 26. Qilu ndiyo kambani yekutanga yepamba kutumira chikumbiro chekutengesa chekugadzirwa uku. Mukuwedzera, CSPC Ouyi iri muBE nhanho yekuedza.

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