I-Tofacitinib citrate iyiyeza elimiselweyo (igama lokurhweba i-Xeljanz) elaphuhliswa ekuqaleni nguPfizer kwiklasi ye-oral Janus kinase (JAK) inhibitors.Inokuthintela ngokukhethekileyo i-JAK kinase, ibhloke iindlela ze-JAK / STAT, kwaye ngaloo ndlela inqanda ukuhanjiswa komqondiso weseli kunye ne-Related gene expression and activation, esetyenziselwa ukunyanga i-rheumatoid arthritis, i-psoriatic arthritis, i-ulcerative colitis kunye nezinye izifo zokuzivikela.

Ichiza libandakanya iifom ezintathu zedosi: iipilisi, iipilisi ezikhutshwa ngokuqhubekayo kunye nezisombululo zomlomo.Iipilisi zayo zaqala ukuvunywa yi-FDA kwi-2012, kwaye ifom ye-dosage yokukhutshwa ngokuqhubekayo yavunywa yi-FDA ngoFebruwari 2016. Yeyokuqala ukunyanga amalungu e-rheumatoid.I-Yan yi-JAK inhibitor ethathwe ngomlomo kanye ngosuku.NgoDisemba ka-2019, isalathiso esitsha samachiza akhutshwa ngokuzinzileyo samkelwa kwakhona ukuba aphakathi ukuya kokubi asebenzayo esilonda esilonda isilonda esiswini (UC).Ukongezelela, isigaba sangoku se-3 izilingo zeklinikhi ze-plaque psoriasis zigqityiwe, kwaye ezinye iimvavanyo zekliniki ze-3 ziyaqhubeka, ezibandakanya i-psoriatic arthritis esebenzayo, i-juvenile idiopathic arthritis, njl. Uhlobo lwezibonakaliso.Izibonelelo zeepilisi ezikhutshwa ngokuqhubekayo ezithatha ixesha elide kwaye zifuna ukuba zithathwe kanye ngosuku ziluncedo kulawulo nokulawula izifo zezigulane.

Ukususela kuluhlu lwayo, intengiso yayo iye yanda unyaka nonyaka, yafikelela kwi-US $ 2.242 yezigidigidi ngo-2019. E-China, ifom ye-tablet yedosi yamkelwa ukuthengiswa ngo-Matshi 2017, kwaye yangena kwikhathalogu ye-inshurensi yezonyango ngothethwano ngo-2019. ibhidi yi-RMB 26.79.Nangona kunjalo, ngenxa yezithintelo eziphezulu zobuchwepheshe zamalungiselelo okukhululwa okuzinzileyo, le fomu yedosi ayikathengiswa e-China.

I-JAK kinase idlala indima ebalulekileyo ekudumbeni, kwaye i-inhibitors yayo ibonakaliswe ukunyanga izifo ezithile ezivuthayo kunye ne-autoimmune.Ukuza kuthi ga ngoku, i-7 JAK inhibitors ivunyiwe kwihlabathi jikelele, kuquka i-Leo Pharma's Delgocitinib, i-Celgene's Fedratinib, i-AbbVie's upatinib, i-Astellas's Pefitinib, i-Eli Lilly's Baritinib kunye ne-Novartis's Rocotinib.Nangona kunjalo, kuphela i-tofacitinib, i-baritinib kunye ne-rocotinib evunyiweyo e-China phakathi kweziyobisi ezikhankanywe ngasentla.Sijonge ngethemba “kwiTofatib Citrate Sustained Release Tablets” zikaQilu ezivunyiweyo ngokukhawuleza kwaye kuxhamle izigulana ezininzi.

E-China, uphando lwangaphambili lwe-tofacitib citrate luvunyiwe yi-NMPA ngo-Matshi 2017 kunyango lwezigulane ze-RA zabantu abadala ezinokungasebenzi ngokwaneleyo okanye ukunyamezela kwi-methotrexate, phantsi kwegama lezorhwebo elithi Shangjie.Ngokwedatha evela kuMeinenet, ukuthengiswa kweetafile ze-tofacitib citrate kumaziko onyango aseTshayina ngo-2018 yayizizigidi ezisisi-8.34 zeeyuan, eyayiphantsi kakhulu kunentengiso yayo yehlabathi.Inxalenye enkulu yesizathu lixabiso.Kuxelwe ukuba ixabiso lokuqala likaShangjie laliyi-2085 yuan (5mg*28 tablets), kwaye ixabiso lenyanga laliyi-4170 yuan, ayingomthwalo omncinci kwiintsapho eziqhelekileyo.

Nangona kunjalo, kuyafaneleka ukubhiyozela ukuba i-tofacitib ifakwe kwi-2019 "I-Inshurensi yeSizwe yezoNyango, i-Inshurensi yokulimala komsebenzi kunye noLuhlu lweziyobisi ze-Inshurensi yokubeleka" yi-National Medical Insurance Administration emva kothethathethwano ngoNovemba 2019. Kuxelwa ukuba umrhumo wenyanga uya kuncitshiswa. ukuya ngaphantsi kwama-2,000 eyuan emva kokuba kuxoxiwe ukuthotywa kwexabiso, okuya kuphucula kakhulu ukufumaneka kwechiza.

Ngo-Agasti 2018, iBhodi yokuHlola kwakhona i-Patent ye-ofisi ye-State Intellectual Property yenza isigqibo sokuphononongwa kwesicelo esinguNombolo 36902 sokungasebenzi, kwaye yabhengeza ukuba ayivumelekanga i-patent engundoqo ye-Pfizertofatib, i-compound patent, ngenxa yezizathu zokungachazwa ngokwaneleyo kwenkcazo.Nangona kunjalo, i-patent ye-Pfizertofatiib crystal form (ZL02823587.8, CN1325498C, umhla wesicelo 2002.11.25) iya kuphelelwa yisikhathi kwi-2022.

I-database ye-Insight ibonisa ukuba, ukongeza kuphando lwangaphambili, amachiza amahlanu enziwe afana nalawo enziwe afana nalawo enziwe afana nalawo enziwe ngabenzi beChia Tai Tianqing, iQilu, iKelun, iYangtze River, kunye neNanjing Chia Tai Tianqing avunyiweyo ukuba athengiswe kuqulunqo lwethebhulethi yetofacitinib yasekhaya.Nangona kunjalo, kuhlobo lwethebhulethi yokukhutshwa ngokuqhubekayo, kuphela uphando lwangaphambili lwePfizer lungenise isicelo sokuthengisa ngoMeyi 26. I-Qilu yinkampani yokuqala yasekhaya ukungenisa isicelo sokuthengisa kolu qulunqo.Ukongeza, i-CSPC Ouyi ikwinqanaba lovavanyo lwe-BE.

I-Changzhou Pharmaceutical Factory (CPF) ngumvelisi ohamba phambili wamachiza we-APIs, uqulunqo olugqityiweyo e-China, oluse-Changzhou, kwiphondo laseJiangsu.I-CPF isekelwe kwi-1949. Sizinikezele kwi-Tofacitinib Citrate ukusuka kwi-2013, kwaye singenise i-DMF kakade.Sibhalise kumazwe amaninzi, kwaye sinokukuxhasa ngenkxaso yamaxwebhu angcono eTofacitinib Citrate.