Tofacitinib citrate ndi mankhwala osokoneza bongo (dzina la malonda Xeljanz) lopangidwa ndi Pfizer kwa gulu la oral Janus kinase (JAK) inhibitors. Ikhoza kuletsa mwachisawawa JAK kinase, kutsekereza njira za JAK / STAT, ndipo potero kuletsa kutengera kwa ma cell ndi mafotokozedwe amtundu wofananira ndi kuyambitsa, komwe kumagwiritsidwa ntchito pochiza nyamakazi ya nyamakazi, nyamakazi ya psoriatic, ulcerative colitis ndi matenda ena a chitetezo chamthupi.

Mankhwalawa akuphatikizapo mitundu itatu ya mlingo: mapiritsi, mapiritsi omasulidwa nthawi zonse ndi njira zoyankhira pakamwa. Mapiritsi ake adavomerezedwa koyamba ndi FDA mu 2012, ndipo mawonekedwe a mlingo wokhazikika adavomerezedwa ndi FDA mu February 2016. Ndiwoyamba kuchiza matenda a nyamakazi. Yan ndi JAK inhibitor yotengedwa pakamwa kamodzi patsiku. Mu Disembala 2019, chisonyezo chatsopano chamankhwala otulutsidwa mosalekeza chidavomerezedwanso kuti chikhale chochepa mpaka choopsa kwambiri cha ulcerative colitis (UC). Kuonjezera apo, mayesero amakono a 3 a matenda a plaque psoriasis atsirizidwa, ndipo mayesero ena asanu ndi limodzi a 3 akuchitika, okhudza nyamakazi yogwira ntchito ya psoriatic, matenda a nyamakazi achichepere, ndi zina zotero. Ubwino wa mapiritsi otulutsidwa omwe akugwira ntchito kwa nthawi yayitali ndipo amangofunika kutengedwa kamodzi patsiku amathandizira kuwongolera ndi kuwongolera matenda a odwala.

Kuchokera pamndandanda wake, malonda ake akuchulukirachulukira chaka ndi chaka, kufika $2.242 biliyoni mu 2019. Ku China, mawonekedwe a mapiritsi a piritsi adavomerezedwa kuti azigulitsa mu Marichi 2017, ndipo adalowa mgulu la inshuwaransi yamagulu B kudzera pazokambirana mu 2019. Kupambana kwaposachedwa. mtengo ndi RMB 26.79. Komabe, chifukwa cha zotchinga zapamwamba zaukadaulo wokonzekera kumasulidwa kosalekeza, mawonekedwe a mankhwalawa sanagulitsidwebe ku China.

JAK kinase imakhala ndi gawo lofunikira pakutupa, ndipo zoletsa zake zawonetsedwa kuti zimathandizira matenda ena otupa ndi autoimmune. Mpaka pano, 7 JAK inhibitors zavomerezedwa padziko lonse lapansi, kuphatikizapo Leo Pharma's Delgocitinib, Celgene's Fedratinib, AbbVie's upatinib, Astellas's Pefitinib, Eli Lilly's Baritinib Ndi Novartis's Rocotinib. Komabe, tofacitinib, baritinib ndi rocotinib okha amavomerezedwa ku China pakati pa mankhwala omwe tawatchula pamwambapa. Tikuyembekezera kuti "Tofatib Citrate Sustained Release Tablets" a Qilu avomerezedwe posachedwa ndikupindulitsa odwala ambiri.

Ku China, kafukufuku woyambirira wa tofacitib citrate adavomerezedwa ndi NMPA mu Marichi 2017 kuti azichiza odwala akuluakulu a RA omwe alibe mphamvu zokwanira kapena kusalolera methotrexate, pansi pa dzina lamalonda la Shangjie. Malinga ndi kafukufuku wa Meinenet, kugulitsa mapiritsi a tofacitib citrate m'mabungwe azachipatala aku China mu 2018 anali 8.34 miliyoni yuan, omwe anali otsika kwambiri kuposa malonda ake padziko lonse lapansi. Chifukwa chachikulu ndi mtengo. Akuti mtengo woyamba wa Shangjie wogulitsa unali 2085 yuan (mapiritsi a 5mg*28), ndipo mtengo wake wapamwezi unali 4170 yuan, zomwe sizovuta kwa mabanja wamba.

Komabe, ndikofunikira kukondwerera kuti tofacitib idaphatikizidwa mu 2019 "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug List" ndi National Medical Insurance Administration pambuyo pokambirana mu Novembala 2019. Akuti chindapusa cha pamwezi chidzachepetsedwa kufika pansi pa 2,000 yuan pambuyo pokambitsirana zodula mtengo, zomwe zingathandize kwambiri kupezeka kwa mankhwalawa.

Mu Ogasiti 2018, Patent Reexamination Board of the State Intellectual Property Office idapanga chigamulo chowunikiranso No. 36902 pempho losavomerezeka, ndipo idalengeza kuti patent yayikulu ya Pfizertofatib, patent patent, chifukwa chosakwanira kuwululidwa kwazomwe zafotokozedwazo. Komabe, patent ya Pfizertofatiib crystal form (ZL02823587.8, CN1325498C, tsiku lofunsira 2002.11.25) idzatha mu 2022.

Dongosolo la Insight likuwonetsa kuti, kuphatikiza pa kafukufuku woyambirira, mankhwala asanu a Chia Tai Tianqing, Qilu, Kelun, Yangtze River, ndi Nanjing Chia Tai Tianqing avomerezedwa kuti azigulitsa pagulu lamapiritsi a tofacitinib. Komabe, pamtundu wa piritsi lotulutsidwa mosalekeza, kafukufuku woyambirira wokhawo Pfizer adapereka ntchito yotsatsa pa Meyi 26. Qilu ndi kampani yoyamba yapakhomo kutumiza fomu yotsatsa pakupanga uku. Kuphatikiza apo, CSPC Ouyi ili pagawo la mayeso la BE.

Changzhou Pharmaceutical Factory (CPF) ndiwopanga mankhwala otsogola a APIs, omalizidwa ku China, omwe ali ku Changzhou, m'chigawo cha Jiangsu. CPF idakhazikitsidwa mu 1949. Tadzipereka ku Tofacitinib Citrate kuchokera ku 2013, ndipo tapereka kale DMF. Talembetsa m'maiko ambiri, ndipo titha kukuthandizani ndi zikalata zabwino kwambiri zothandizira Tofacitinib Citrate.