Tofacitinib citrate ose talavai (igoa tau fefa'ataua'iga Xeljanz) na fausia muamua e le Pfizer mo se vasega o fa'amata'u Janus kinase (JAK). E mafai ona filifili filifili JAK kinase, poloka JAK / STAT ala, ma faapea ona taofia le transduction faailoilo feaveai ma Related faʻamatalaga o kenera ma le faʻagaoioia, faʻaaogaina e togafitia ai le gasegase oona, psoriatic arthritis, ulcerative colitis ma isi faʻamaʻi puipuia.
O le vaila'au e aofia ai fa'asologa o vaila'au e tolu: papa'a, papala fa'asa'o ma vaifofo tautala. Na fa'amaonia muamua e le FDA i le 2012 ona papa'a, ma na fa'amaonia e le FDA le fomu fa'amatu'u fa'asaoina e le FDA ia Fepuari 2016. O le muamua lea e togafitia ai so'oga rumatika. Yan ose JAK inhibitor inu fa'atasi ile aso. Ia Tesema 2019, na toe faʻamaonia ai se faʻailoga fou mo vailaʻau faʻamalolo tumau mo le faʻaleagaina o le ulcerative colitis (UC). E le gata i lea, o le vaega 3 o loʻo iai nei faʻataʻitaʻiga faʻataʻitaʻiga mo plaque psoriasis ua maeʻa, ma le isi ono vaega 3 faʻataʻitaʻiga faʻataʻitaʻiga o loʻo faʻagasolo, e aofia ai le psoriatic arthritis malosi, juvenile idiopathic arthritis, ma isi. Ituaiga o faʻamaoniga. O le lelei ole sustained-release tablets e umi ona gaioi ma e na'o le tasi i le aso e mana'omia ona inu e fesoasoani i le puleaina ma le puleaina o gasegase o gasegase.
Talu mai lona lisi, o ana faʻatauga ua faʻateleina i lea tausaga ma lea tausaga, e oʻo atu i le US $ 2.242 piliona i le 2019. I Saina, o le faʻasologa o vailaʻau papalama na faʻamaonia mo le maketiina ia Mati 2017, ma ulufale atu i le inisiua fomaʻi vaega B catalog e ala i feutagaiga i le 2019. tauofo e RMB 26.79. Ae ui i lea, ona o le maualuga o paʻu faʻapitoa o sauniuniga faʻasaʻo, e leʻi faʻatauina lenei fomu i Saina.
O le JAK kinase e iai sona sao taua i le mumū, ma o ana inhibitors ua faʻaalia e togafitia ai nisi faʻamaʻi faʻamaʻi ma autoimmune. E oʻo mai i le taimi nei, 7 JAK inhibitors ua faʻamaonia i le lalolagi atoa, e aofia ai Leo Pharma's Delgocitinib, Celgene's Fedratinib, AbbVie's upatinib, Astellas's Pefitinib, Eli Lilly's Baritinib ma Novartis's Rocotinib. Ae ui i lea, naʻo le tofacitinib, baritinib ma le rocotinib e faʻamaonia i Saina i totonu o vailaʻau o loʻo taʻua i luga. Matou te tulimatai atu i le Qilu's "Tofatib Citrate Sustained Release Tablets" e faʻamaonia i se taimi vave e mafai ai ma manuia ai le tele o gasegase.
I Saina, o le uluai suʻesuʻega o le tofacitib citrate na faʻamaonia e le NMPA ia Mati 2017 mo le togafitia o tagata matutua RA maʻi ma le le lava o le aoga poʻo le le faapalepale i le methotrexate, i lalo o le igoa tau fefaʻatauaʻiga Shangjie. E tusa ai ma faʻamatalaga mai le Meinenet, o le faʻatau atu o tofacitib citrate tablets i Saina faʻalapotopotoga faʻafomaʻi i le 2018 e 8.34 miliona yuan, lea e sili atu ona maualalo nai lo ana faʻatauga i le lalolagi atoa. O se vaega tele o le mafuaaga o le tau. Ua lipotia mai o le tau muamua o le faatauina atu o Shangjie o le 2085 yuan (5mg * 28 tablets), ma o le tau faalemasina o le 4170 yuan, e le o se avega laitiiti mo aiga masani.
Ae ui i lea, e taua le faʻamanatuina o le tofacitib na aofia i le 2019 "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug List" e le National Medical Insurance Administration ina ua maeʻa feutagaiga ia Novema 2019. Ua lipotia mai o le a faʻaititia le totogi masina. i lalo ifo o le 2,000 yuan pe a maeʻa ona faʻatalanoaina le tau, lea o le a faʻaleleia atili ai le maua o le vailaʻau.
I le masina o Aokuso 2018, na faia ai e le Komiti o le Toe Iloiloina o Pateni a le Ofisa o Meatotino a le Setete se faaiuga iloiloga Numera 36902 talosaga mo le faʻaleaogaina, ma faʻaalia le le aoga o le pateni autu o le Pfizertofatib, le pateni faʻapipiʻi, i luga o le mafuaaga o le le lava o le faʻaalia o le faʻamatalaga. Ae ui i lea, o le pateni o le Pfizertofatiib crystal form (ZL02823587.8, CN1325498C, aso talosaga 2002.11.25) o le a muta i le 2022.
O loʻo faʻaalia e le Insight database e faʻapea, i le faaopoopo atu i le uluai suʻesuʻega, e lima vailaʻau lautele o Chia Tai Tianqing, Qilu, Kelun, Yangtze River, ma Nanjing Chia Tai Tianqing ua faʻamaonia mo le maketiina i totonu ole fale tofacitinib tablet formulations. Ae ui i lea, mo le ituaiga papalama faʻasalalau, naʻo le uluai suʻesuʻega Pfizer na tuʻuina atu se talosaga tau maketi i le aso 26 o Me. O Qilu o le kamupani muamua i totonu o le atunuʻu na tuʻuina atu se talosaga tau maketi mo lenei faʻatulagaga. E le gata i lea, CSPC Ouyi o loʻo i totonu o le BE trial stage.
Changzhou Pharmaceutical Factory (CPF) o se taʻutaʻua gaosi vailaʻau o API, faʻamaeʻaina faʻasologa i Saina, lea e tu i Changzhou, Jiangsu itumalo. CPF ua faavaeina i le 1949. Ua matou tuuto atu i le Tofacitinib Citrate mai le 2013, ma ua uma ona tuʻuina atu le DMF. Ua matou lesitala i le tele o atunuu, ma e mafai ona matou lagolagoina oe i pepa sili ona lelei mo le Tofacitinib Citrate.
Taimi meli: Iul-23-2021