I-Tofacitinib citrate iwumuthi kadokotela (igama lokuhweba elithi Xeljanz) owaqalwa u-Pfizer wekilasi le-oral Janus kinase (JAK) inhibitors. Ingakwazi ukuvimbela ngokukhetha i-JAK kinase, ivimbe izindlela ze-JAK/STAT, futhi ngaleyo ndlela ivimbele ukudluliselwa kwesignali yeseli kanye nenkulumo ehlobene yezakhi zofuzo nokusebenza kusebenze, okusetshenziselwa ukwelapha isifo samathambo, i-psoriatic arthritis, i-ulcerative colitis nezinye izifo zokuzivikela komzimba.

Umuthi uhlanganisa amafomu amathathu omthamo: amaphilisi, amaphilisi akhishwa njalo kanye nezixazululo zomlomo. Amaphilisi awo agunyazwa okokuqala yi-FDA ngo-2012, futhi ifomu lesilinganiso sokukhishwa okuqhubekayo lagunyazwa yi-FDA ngoFebhuwari 2016. Elokuqala ukwelapha amalunga e-rheumatoid. I-Yan iyi-inhibitor ye-JAK ethathwa ngomlomo kanye ngosuku. NgoZibandlela wezi-2019, inkomba entsha yezidakamizwa ezikhishwa isikhathi eside yaphinde yagunyazwa ukuze ihlolwe i-ulcerative colitis (UC) emaphakathi ukuya kokuqina. Ukwengeza, ukuhlolwa komtholampilo kwesigaba sesi-3 samanje se-plaque psoriasis sekuqediwe, futhi ezinye izivivinyo zomtholampilo zesigaba se-3 ziyaqhubeka, ezibandakanya i-psoriatic arthritis esebenzayo, i-juvenile idiopathic arthritis, njll. Uhlobo lwezinkomba. Izinzuzo zamaphilisi akhishwa isikhathi eside asebenza isikhathi eside futhi adinga ukuphuza kanye kuphela ngosuku ayasiza ekulawuleni nasekulawuleni izifo zeziguli.

Selokhu yafakwa ohlwini, ukuthengiswa kwayo kwenyukile unyaka nonyaka, kwafinyelela ku-US$2.242 billion ngo-2019. E-China, ifomu lethamo lethebhulethi lagunyazwa ukuthi lidayiswe ngoMashi 2017, futhi langena kukhathalogi yesigaba somshwalense wezokwelapha esigabeni B ngezingxoxo ngo-2019. Ukuwina kwakamuva Ibhidi yi-RMB 26.79. Kodwa-ke, ngenxa yezithiyo eziphezulu zobuchwepheshe zamalungiselelo okukhishwa okuqhubekayo, leli fomu lomthamo alikakamakethwa e-China.

I-JAK kinase idlala indima ebalulekile ekuvuvukeni, futhi ama-inhibitors ayo aboniswe ukuphatha izifo ezithile ezivuthayo kanye ne-autoimmune. Kuze kube manje, ama-JAK inhibitors angu-7 avunyelwe emhlabeni jikelele, okuhlanganisa i-Delgocitinib ka-Leo Pharma, i-Fedratinib ka-Celgene, i-upatinib ka-AbbVie, i-Pefitinib ka-Astellas, i-Baritinib ka-Eli Lilly Kanye ne-Rocotinib ka-Novartis. Kodwa-ke, i-tofacitinib kuphela, i-baritinib ne-rocotinib evunyelwe e-China phakathi kwezidakamizwa ezibalwe ngenhla. Sibheke ngabomvu ukuthi “I-Tofatib Citrate Sustained Release Tablet” ye-Qilu izogunyazwa ngokushesha ngangokunokwenzeka futhi izuzise iziguli ezengeziwe.

E-China, ucwaningo lwangempela lwe-tofacitib citrate lugunyazwe yi-NMPA ngoMashi 2017 ukuze zelashwe iziguli ze-RA zabantu abadala ngokungasebenzi okwanele noma ukungabekezeleli i-methotrexate, ngaphansi kwegama lokuhweba elithi Shangjie. Ngokwemininingwane evela ku-Meinenet, ukuthengiswa kwamaphilisi e-tofacitib citrate ezikhungweni zezokwelapha zomphakathi zaseChina ngo-2018 bekungama-yuan ayizigidi eziyi-8.34, okwakuphansi kakhulu kunokuthengiswa kwawo emhlabeni jikelele. Ingxenye enkulu yesizathu yinani. Kubikwa ukuthi intengo yokuqala ka-Shangjie yokudayisa yayingama-yuan angu-2085 (amaphilisi angu-5mg*28), futhi izindleko zanyanga zonke zazingu-4170 yuan, okungewona umthwalo omncane emindenini evamile.

Kodwa-ke, kufanelekile ukugubha ukuthi i-tofacitib ifakwe ku-2019 "Umshwalense Kazwelonke Oyisisekelo Wezokwelapha, Umshwalense Wokulimala Kwasemsebenzini kanye Nohlu Lwezidakamizwa Zomshwalense Wokubeletha" yi-National Medical Insurance Administration ngemva kwezingxoxo ngoNovemba 2019. Kubikwa ukuthi imali yanyanga zonke izokwehliswa ukuya ngaphansi kwama-yuan angu-2,000 ngemva kokuxoxisana kokwehliswa kwentengo, okuzokwenza ngcono kakhulu ukutholakala komuthi.

Ngo-Agasti 2018, Ibhodi Lokuhlolwa Kabusha Kwelungelo Lobunikazi leHhovisi Lombuso Lendawo Yengqondo yenza isicelo sokubuyekeza inombolo 36902 sokungavumeleki, futhi lamemezela elingavumelekile ilungelo lobunikazi eliyinhloko le-Pfizertofatib, ilungelo lobunikazi elihlanganisiwe, ngezizathu zokungadalulwa okwanele kwencazelo. Nokho, ilungelo lobunikazi lefomu lekristalu le-Pfizertofatiib (ZL02823587.8, CN1325498C, usuku lokufaka isicelo 2002.11.25) lizophelelwa yisikhathi ngo-2022.

Idatha egciniwe ye-Insight ibonisa ukuthi, ngaphezu kocwaningo lwangempela, izidakamizwa ezinhlanu ezijwayelekile ze-Chia Tai Tianqing, Qilu, Kelun, Yangtze River, kanye ne-Nanjing Chia Tai Tianqing zivunyelwe ukumakethwa ekwenziweni kwethebulethi ye-tofacitinib yasekhaya. Kodwa-ke, ohlotsheni lwethebhulethi ekhishwa njalo, wucwaningo lwangempela kuphela i-Pfizer ethumele isicelo sokumaketha ngoMeyi 26. I-Qilu iyinkampani yasekhaya yokuqala ukuhambisa isicelo sokumaketha salokhu kwakhiwa. Ngaphezu kwalokho, i-CSPC Ouyi isesigabeni sesivivinyo se-BE.

I-Changzhou Pharmaceutical Factory (CPF) ingumkhiqizi ohamba phambili kwezemithi wama-API, ukwakheka okuqediwe e-China, etholakala e-Changzhou, esifundazweni saseJiangsu. I-CPF yasungulwa ngo-1949. Sizinikele ku-Tofacitinib Citrate kusukela ngo-2013, futhi sesivele siyithumele i-DMF. Sibhalise emazweni amaningi, futhi singakusekela ngokusekela imibhalo engcono kakhulu ye-Tofacitinib Citrate.