Ga jerin sababbin magungunan cutar sankara a cikin kasuwa.
1) Epacadostat
Epacadostat babu shakka tauraro ne mai haske a cikin filin IDO. Sakamakon gwaje-gwaje na asibiti ya nuna cewa haɗuwa da masu hana IDO da shirye-shiryen mai karɓa na mutuwa 1 (PD-1) antibody monoclonal yana da wasu fa'idodi akan PD-1 kadai. anti. Incyte ya cimma yarjejeniyar haɗin gwiwa tare da ƙattai biyu na PD-1 monoclonal antibody Merck da BMS, kuma ya bincika dalla-dalla aikin haɗin gwiwar Epacadostat da sauran masu hana shinge na rigakafi. Alamun sun kuma ƙunshi nau'ikan ciwon daji da yawa, amma da alama Incyte bai gamsu da wannan ba, kowane motsin su ya jawo hankali sosai. Incyte ya sayi ci gaban duniya da haƙƙin kasuwanci na duk alamun Macrogenis 'PD-1 monoclonal antibody drug MGA012 a cikin Oktoba don ƙara ƙarfafa bututun sa na PD-1. An yi imanin cewa haɗin MGA012 da Epacadostat zai fara nan da nan.
2) Rova-T
Rova-T magani ne na kwayar cutar kanjamau wanda ke ƙaddamar da furotin DLL3 akan ɓarkewar ƙwayoyin cuta. Ana amfani da shi don layi na biyu haɗe magani na karamin cutar kansa na huhu kuma har yanzu yana cikin matakin gwaji. AbbVie ya yi imanin cewa Rova-T haɗe tare da Opdivo ko Opdivo + Yervoy zai sa ta zama mai nasara a ƙananan ƙwayoyin cuta na huhu, amma ana buƙatar ƙarin gwajin asibiti don tabbatar da nasararta.
3) ARN-509
Apalutamide (ARN-509) wani sabon ƙarni ne na magungunan anti-androgen da aka haɓaka don maganin ciwon daji na prostate. Johnson & Johnson ya kasance cikin nutsuwa yana haɓaka haɓakar asibiti na apalutamide, kuma kodayake ba a ga waɗannan bayanan ba, yana da ban sha'awa don ganin ya matsa zuwa hukumomin gudanarwa. Tare da ƙungiyar haɓaka kasuwanci mai ƙarfi ta Johnson & Johnson, ana tsammanin wannan nau'in zai zama maganin toshewa.
4) Tafarnuwa
Tun farkon Yuni 2012, FDA ta amince da Pertuzumab. An yi amfani da shi a hade tare da trastuzumab da docetaxel don ciwon nono mai tsanani ba tare da maganin HER2 + ko chemotherapy ba. A cikin Satumba 2013, FDA ta ƙara amincewa da Pertuzumab. Anyi amfani dashi a hade tare da trastuzumab da chemotherapy don maganin neoadjuvant na HER2 + ciwon nono. A ranar 20 ga Disamba, 2017, FDA ta amince da haɗuwa da Pertuzumab tare da Trastuzumab da chemotherapy don kulawa da marasa lafiya tare da farkon matakin HER2 + ciwon nono tare da haɗarin sake dawowa. A lokaci guda, FDA ta canza Pertuzumab ta baya adjuvant far for HER2 + ciwon nono daga hanzari yarda zuwa cikakken yarda.
5) Odivo
Opdivo ɗayan ɗayan PD-1 mAbs da aka fi amfani da shi sosai a cikin aikin asibiti, kuma FDA ta amince da alamomi tara. Takaddun jerin sunayen Opdivo don neman layin na biyu na cutar kanjamau da ba ta karamin kwayar cuta ba a kasar Sin ta samu karbuwa daga CDE a ranar 2 ga Nuwamba, 2017, kuma an sanya ta a cikin fifikon binciken da CDE ta yi a ranar 18 ga Disamba bisa dalilin cewa "tana da muhimmanci wadatar warkewa idan aka kwatanta da magungunan da ake dasu ”.
6) Maganin Thiopenfigrastin
Allurar Thiofeigrastin, 19K (HHPG-19K, polyethylene glycol recombinant adam granulocyte stimulating factor allura), ana iya amfani da shi a asibiti don ƙwayoyin cuta masu alaƙa da cutar sankara a cikin marasa lafiya na ƙari. 19K ya gabatar da aikace-aikacen jerin sunayen (CXSS1300007) tun a ranar 4 ga Maris, 2013. Ganin cewa yana kan kasuwa ba da daɗewa ba, sai ya kama da gwajin asibiti na asibiti a ranar 22 ga Yulin, 2015. A ranar 18 ga Mayu, 2016, Hengrui ya ba da sanarwa don janye aikace-aikacen jerin sunayen 19K, kuma ya bayyana cewa zai kammala bayanan bincike da ci gaban da suka dace kuma ya kara aikace-aikacen da wuri-wuri. A ranar 24 ga Maris, 2017, Hengrui ya sake yin rajista don jerin 19K a ƙarƙashin sunan magani na allurar thiopefilgrastim. Ya taɓa bayyana a cikin CDE tare da dalilin “bayyananniyar fa'idar jiyya idan aka kwatanta da magungunan da ake da su da kuma manyan ayyuka”. An tsara shi don saka shi a cikin jerin abubuwan fifikon fifiko. Kodayake ba a haɗa shi a cikin binciken na ƙarshe ba, an kammala nazarin fasaha a ranar 13 ga Oktoba 2017, 2018, kuma yana jiran tabbacin kan shafin. Idan an ci nasara, ana tsammanin samun izinin CFDA a cikin 2QXNUMX.
7) Anlotinib
Anlotinib shine mai hana tyrosine kinase mai hanawa da yawa, wanda zai iya hana VEGFR, PDGFR, FGFR, c-Kit da sauran kinases yadda ya kamata. Yana da anti-tumor angiogenesis kuma yana hana ci gaban ƙari. Ya sami manyan sabbin magunguna na ƙasa Tallafi na musamman don ƙirƙirar. CDE ta karɓi aikace-aikacen Anlotinib don maganin ciwon huhu mara ƙanƙara a ranar 16 ga Maris, 2017, kuma ta ɗauki tashar amincewa ta musamman. A ranar 27 ga Afrilu, 2017, tana da "mahimman fa'idodin jiyya idan aka kwatanta da jiyya na yanzu". Dalilin "babban aikin" an haɗa shi a cikin fifikon bita ta CDE. A halin yanzu, an kammala nazarin fasaha na ilimin harhada magunguna da toxicology da sassan asibiti, kuma ana sahun sashin kantin magani don dubawa. Bayan haka, za ta shiga binciken da aka yi a wurin kuma ta ba da rahoton uku-biyu.
8) Pirlotinib
Pirlotinib karamin mai hana EGFR/HER2 ne, wanda aka kirkireshi don maganin HER2 + ciwon nono, ciwon ciki da kuma NSCLC, kuma ya sami tallafi na musamman daga Babban Maɓallin Sabbin Magunguna na Ƙasa. Wani sabon aikin magani ne wanda Hengrui ke da babban fata. Hengrui an ƙaddamar da shi ga CDE aikace-aikacen jeri na sharadi don pirlotinib don ciwon nono. CDE ta karɓi aikace-aikacen a ranar 24 ga Agusta, 2017, kuma ta ɗauki tashar amincewa ta musamman. A kan Satumba 26, 2017, yana da "mahimmancin darajar asibiti, "Babban aikin" dalili ya haɗa da mahimmancin bita ta CDE. A halin yanzu, an kammala nazarin fasaha na sashin asibiti, kuma an yi jerin gwano na magunguna da magunguna da toxicological sassan don dubawa. Ana sa ran za a amince da CFDA a cikin 2018Q2.
9) Fruquintinib
Fruquintinib ƙaramin ƙwayoyin VEGFR ne mai hanawa wanda Hehuang Medicine ya haɓaka kansa. Ana shirin samar da shi don maganin ciwon daji, ciwon ciki, da kuma NSCLC. CDE ta karɓi aikace-aikacen Fruquintinib don maganin ciwon daji na ci gaba da CDE a ranar 30 ga Yuni, 2017, kuma an haɗa shi a cikin bitar fifiko ta CDE a kan Satumba 4, 2017 a kan dalilan cewa yana da “mahimman ƙimar asibiti; manyan ayyuka”. A halin yanzu, an kammala nazarin fasaha na fannin harhada magunguna da toxicology, kuma kantin magani da layukan asibiti suna jiran bita. Ana sa ran CFDA za ta amince da shi don jeri a cikin 2018Q3.
10) Olapalli
Lynparza shine farkon mai hanawa na PARP a duniya bisa tsarin aikin lalata DNA (DDR). Hukumar ta FDA ta fara amincewa dashi a watan Disambar 2014 don yin layi na huɗu na ci gaban BRCA + cutar sankarar jakar kwai. A ranar 17 ga watan Yulin, wannan shekarar, hukumar ta FDA ta amince da ita don kula da layin na biyu a cikin marasa lafiya da ke fama da cutar sankarar mahaifa, cutar sankarar mahaifa, da kuma cutar sankara ta farko wacce ta koma bayan amsa magunguna da sinadarin platinum. Zuwa yau, Lynparza ya kula da marasa lafiya sama da 30,000 da ke fama da cutar kansa. A ranar 18 ga watan Oktoba, AstynZeneca / Mercedon's Lynparza sun gabatar da shi ga FDA don maganin kwayar cutar kwayar cutar BRCA da HER2-aikace-aikacen sayar da cutar sankarar mama (sNDA) FDA ta karba ta kuma samu
fifikon cancantar bita, mai dacewa Ana sa ran taron za su fadada sosai.
11) Lenvatinib
Lemvatinib shine mai hanawa kinase mai yawan niyya wanda zai iya toshe jerin abubuwan da suka dace ciki har da VEGFR1-3, FGFR1-4, PDGFRα, KIT, RET a cikin ƙwayoyin tumor. A ranar 13 ga Fabrairu, 2015, FDA ta amince da ita a matsayin bita na fifiko da magungunan marayu don tallatawa a matsayin magani ga babban haɗarin bambance-bambancen ciwon daji na thyroid wanda ke da alaƙa da iodine radioactive. Mayu 13, 2016 FDA ta amince da shi tare da Afinitor don magance ci-gaba na ciwon daji na renal carcinoma tare da anti-VEGF na baya. Don alamun ciwon hanta, Eisai ya ƙaddamar da aikace-aikacen tallace-tallace a Japan a watan Yuni 2017, ya ƙaddamar da aikace-aikacen tallace-tallace ga EMA da FDA a watan Yuli 2017, kuma ya ƙaddamar da aikace-aikacen tallace-tallace ga CFDA a kan Nuwamba 3, 2017. An samo shi a kan Disamba 18, Binciken fifiko na 2017 CDE. FDA ta ba da cancantar magungunan marayu don lenvaltinib don magance ciwon hanta. Ta karɓi sNDA na Eisai a ranar 27 ga Satumba, kuma ta yanke shawarar amincewa daidai da tsarin bita na watanni 10, wanda za a amince da shi kafin ƙarshen Yuli.
12) Ceritinib
Certinib shine mai hanawa na anaplastic lymphoma kinase (ALK) na ƙarni na biyu. FDA ta amince da ita a ranar 29 ga Afrilu, 2014 don crizotinib don rashin haƙuri ko ci gaba da cututtuka a cikin ALK + ciwon huhu na huhu, 2017. Mayu 26 FDA ta amince da maganin farko na ALK + metastatic marasa ciwon huhu na huhu. Novartis' ceritinib capsule listing aikace-aikacen CDE ya karɓi bisa ƙa'ida a ranar 11 ga Disamba, 2017. Ya kamata a haɗa shi cikin bitar fifiko daga baya ( aikace-aikacen asibiti sun sami bitar fifiko). Ana sa ran CFDA za ta amince da shi a cikin 2018Q4. Abubuwan da ke sama sun taƙaita sabbin magunguna a cikin maganin cutar kansa. Ana amfani da magungunan sosai a cikin ciwon daji na huhu, ciwon ciki, ciwon hanta, ciwon nono, da ciwon daji na ovarian.
