Tofacitinib Citrate

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Tofacitinib citrate ose vaila'au talavai (igoa fefa'ataua'iga Xeljanz) na fausia muamua e le Pfizer mo se vasega o fa'agata Janus kinase (JAK).E mafai ona filifili filifili JAK kinase, poloka JAK / STAT ala, ma faapea ona taofia le transduction faailoilo feaveai ma Related gene faʻamatalaga 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, papa'a fa'asa'oloto ma vaifofo tautala.O ona papa'a na fa'amaonia muamua e le FDA i le 2012, ma o le sustained-release dosage form na fa'amaonia e le FDA ia Fepuari 2016. O le muamua lea e togafitia ai so'oga rumatika.Yan ose JAK inhibitor e 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 maʻi gugu psoriatic, maʻi gugu idiopathic talavou, ma isi. Ituaiga o faʻamaoniga.O le lelei ole sustained-release tablets e umi ona galue ma e na o le tasi lava le taimi e inu ai i le aso 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 pepa faʻasologa o fualaʻau na faʻamaonia mo le maketiina ia Mati 2017, ma ulufale 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 pa puipui faʻapitoa o sauniuniga faʻasaʻo faʻaauau, e leʻi faʻatauina lenei fomu fua i Saina.

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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 ma faʻamanuiaina ai le tele o gasegase.

I Saina, o le uluai suʻesuʻega 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 faʻapalepale 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 sa 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 o 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 Patent Reexamination Board a le State Intellectual Property Office 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 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.E le gata i lea, o le CSPC Ouyi o loʻo i le BE trial stage.

Changzhou Pharmaceutical Factory (CPF) o se taʻutaʻua gaosi oloa gaosi 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 lagolago mo Tofacitinib Citrate.


Taimi meli: Iul-23-2021