Waa tan liiska daawooyinka lidka ku ah kansarka ee ugu dambeeyay suuqa.
1) Epacadostat
Epacadostat is undoubtedly a bright star in the IDO field. The results of clinical trials show that the combination of IDO inhibitors and programmed death receptor 1 (PD-1) monoclonal antibody has some advantages over PD-1 alone. anti. Incyte has reached a cooperation agreement with the two giants of PD-1 monoclonal antibody Merck and BMS, and also extensively explored the combined function of Epacadostat and other immune checkpoint inhibitors. The indications also cover multiple cancer categories, but Incyte seems Not content with this, their every move has attracted much attention. Incyte purchased the global development and commercial rights of all indications of Macrogenis’ PD-1 monoclonal antibody drug MGA012 in October to further strengthen its PD-1 pipeline. It is believed that the combination of MGA012 and Epacadostat will soon begin.
2) Rova-T
Rova-T waa dawo antibody ah oo bartilmaameedsata borotiinka DLL3 dusha sare ee unugyada asliga ah ee kansarka. Waxaa loo isticmaalaa daaweynta safka labaad ee isku dhafan ee kansarka sanbabada ee unugyada yar welina wuxuu ku jiraa marxaladda tijaabada. AbbVie wuxuu rumeysan yahay in Rova-T oo lagu daray Opdivo ama Opdivo + Yervoy ay ka dhigi doonto guuleyste kansarka sambabka unugyada yar, laakiin tijaabooyin caafimaad oo dheeri ah ayaa loo baahan doonaa si loo caddeeyo guusheeda.
3) ARN-509
Apalutamide (ARN-509) is a new generation of anti-androgen drugs developed for the treatment of prostate cancer. Johnson & Johnson has been quietly advancing the clinical development of apalutamide, and although these data have not been seen, it is also exciting to see it move towards regulatory agencies. With Johnson & Johnson’s strong business development team, this variety is expected to become a blockbuster drug.
4) Pertuzumab
Horraantii Juun 2012, Pertuzumab waxaa ansixiyay FDA. Waxaa loo isticmaalay trastuzumab iyo docetaxel oo loogu talagalay kansarka naasaha ee metastatic iyada oo aan lahayn daawaynta ka hortagga HER2 + ama kiimoterabi. Sebtembar 2013, Pertuzumab waxaa sii ansixisay FDA. Waxaa loo adeegsaday isku darka trastuzumab iyo kiimoterabiga loogu talagalay daawaynta neoadjuvant ee HER2 + kansarka naasaha. Diisambar 20, 2017, FDA waxay ansixisay isku dhafka Pertuzumab ee Trastuzumab iyo kiimoterabiga loogu talagalay daaweynta adjuvant ee bukaannada qaba HER2 + kansarka naasaha ee leh khatarta sare ee soo noqoshada. Isla mar ahaantaana, FDA waxay bedeshay Pertuzumab daawaynta adjuvant ee hore ee HER2 + kansarka naasaha ogolaanshaha degdega ah ilaa ogolaansho buuxda.
5) Opdivo
Opdivo waa mid ka mid ah PD-1 mAbs ee loogu adeegsiga badan yahay adeeg caafimaad, waxaana ansixisay FDA sagaal tilmaam. Codsiga liistada ee Opdivo ee daaweynta khadka labaad ee kansarka sanbabada ee unugyada aan yareyn ee Shiinaha waxaa aqbalay CDE bishii Nofeembar 2, 2017, waxaana lagu soo daray dib u eegista mudnaanta leh ee CDE bishii Diseembar 18 iyada oo sabab looga dhigayo inay "muhiim tahay faa'iidooyinka daweynta marka la barbardhigo daaweynta hadda jirta ”.
6) Cirbadeynta Thiopenfigrastin
Cirbadda Thiofeigrastin, 19K (HHPG-19K, polyetylen glycol recombinant human granulocyte stimulating factor injection), ayaa loo isticmaali karaa bukaan socod eegtada 'neutropenia' ee la xiriirta kemotherabi ee bukaanka burooyinka. 19K waxay soo gudbisay arjiga liistada (CXSS1300007) horaantii Maarso 4, 2013. Markay aragtay inay si dhakhso ah suuqa ugu jirto, waxay la kulantay is-baaritaanka caafimaad ee bishii Luulyo 22, 2015. Maajo 18, 2016, Hengrui waxay soo saartay ogeysiis in laga laabto arjiga liis garaynta 19K, waxayna sheegtay in ay dhameystiri doonto xogta la xiriirta cilmi baarista iyo horumarinta isla markaana ay ku kabi doonto dalabka sida ugu dhakhsaha badan. Markay ahayd 24-kii Maarso, 2017, Hengrui ayaa dib u dalbaday liiska 19K ee ku hoos qoran magaca dawada ee duritaanka thiopefilgrastim. Waxay mar uun ka muuqatay CDE sababtuna tahay "faa'iidooyinka daaweynta ee muuqda marka la barbardhigo daaweynta jirta iyo mashaariicda waaweyn". Waxaa loo qorsheeyay in lagu daro liiska dib u eegista mudnaanta leh. In kasta oo aan lagu darin dib-u-eegista kama-dambaysta ah, dib-u-eegista farsamada waxaa la dhammaystiray Oktoobar 13, 2017, waxayna sugaysaa xaqiijinta goobta. Haddii lagu guuleysto, waxaa la filayaa inay hesho oggolaanshaha CFDA ee 2018Q2.
7) Anlotinib
Anlotinib waa bartilmaameedka badan ee tyrosine kinase inhibitor, kaas oo si wax ku ool ah u joojin kara VEGFR, PDGFR, FGFR, c-Kit iyo kinases kale. Waxay leedahay angiogenesis anti-buro waxayna joojisaa koritaanka burada. Waxa ay heshay dawooyin cusub oo heer qaran ah oo cusub Maalgelin gaar ah oo loogu talagalay abuurista. Codsiga Anlotinib ee daawaynta kansarka sanbabada unug yar waxaa aqbashay CDE March 16, 2017, waxayna qaadatay kanaal oggolaansho gaar ah. Abriil 27, 2017, waxay lahayd "faa'iidooyin daaweyn oo muhiim ah marka loo eego daawaynta jirta". Sababta "mashruuca weyn" waxaa lagu daray dib u eegista mudnaanta ay samaysay CDE. Waqtigan xaadirka ah, dib u eegista farsamada ee dawooyinka iyo toxicology-ga iyo qaybaha bukaan-socodka waa la dhammeeyey, qaybta farmashiyahana waxay saf ugu jirtaa dib-u-eegis. Intaa ka dib, waxay geli doontaa kormeerka goobta waxayna soo saari doontaa warbixin saddex-mid ah.
8) Pirlotinib
Pirlotinib waa EGFR/HER2 molecule inhibitor yar, oo loo sameeyay daawaynta HER2 + kansarka naasaha, kansarka caloosha iyo NSCLC, wuxuuna ka helay maalgelin gaar ah Barnaamijka Horumarinta Dawooyinka Cusub ee Qaranka. Waa mashruuc daroogo cusub oo Hengrui uu rajo weyn ka qabo. Hengrui waxay u gudbisay CDE codsi liis shuruudaysan oo loogu talagalay pirlotinib ee kansarka naasaha. Codsiga waxaa aqbashay CDE Agoosto 24, 2017, waxayna qaadatay kanaal oggolaansho gaar ah. Sebtembar 26, 2017, waxay lahayd "qiimo caafimaad oo muhiim ah, "mashruuca weyn" sababta waxaa lagu daray dib u eegista mudnaanta leh ee CDE. Waqtigan xaadirka ah, dib u eegista farsamada ee qaybta bukaan-socodka ayaa la dhammeeyey, iyo qaybaha dawooyinka iyo dawooyinka iyo sunta sunta ayaa safka ugu jira dib u eegista. Waxa la filayaa in CFDA la ansixiyo 2018Q2.
9) Fruquintinib
Fruquintinib waa molecule yar oo VEGFR horjooge ah oo ay si madax banaan u soo saartay Hehuang Medicine. Waxaa la qorsheeyay in loo horumariyo daaweynta kansarka mindhicirka, kansarka caloosha, iyo NSCLC. Codsiga Fruquintinib ee daawaynta kansarka mindhicirka sare waxa aqbashay CDE bishii Juun 30, 2017, waxaana lagu daray dib u eegista mudnaanta leh ee CDE ee Sebtembar 4, 2017 iyada oo loo eegayo in uu leeyahay “qiimo caafimaad oo muhiim ah; mashaariicda waaweyn”. Waqtigan xaadirka ah, dib u eegista farsamada ee qaybta dawooyinka iyo sunta sunta waa la dhammeeyey, farmashiyaha iyo safafka bukaan-socodka ayaa dib u eegis sugaya. Waxa la filayaa in ay ansixiso CFDA si loogu taxay 2018Q3.
10) Olapalli
Lynparza waa PARP kahortagayaasha adduunka ugu horreeya ee ku saleysan habka jawaab celinta dhaawaca DNA (DDR). Waxaa markii ugu horeysay ansixisay FDA bishii Diseembar 2014 daaweynta khadka afaraad ee kansarka ugxanta ee BRCA +. Bishii Luulyo 17, sanadkaan, waxaa ansixiyay FDA daaweynta dayactirka safka labaad ee bukaanada qaba kansarka ugxan-haweedka epithelial, kansarka xubinta taranka, iyo kansarka xuubka hoose ee soo noqnoqda ka dib markii uu ka jawaabey daawooyinka ku saleysan platina. Ilaa maanta, Lynparza waxay daweysey in ka badan 30,000 bukaan ah oo qaba kansarka daran. Bishii Oktoobar 18-keedii, AstraZeneca / Mercedon's Lynparza ayaa loo gudbiyay FDA-da si loogu beddelo jeermiska daaweynta kemotherabi ee BRCA iyo codsiga suuqgeynta kansarka naasaha ee HER2-metastatic (sNDA) ayaa laga aqbalay FDA waana la helay
mudnaanta dib-u-eegista mudnaanta, lagu dabaqi karo Dadka badan ayaa la filayaa inay si ballaadhan u ballaadhaan.
11) Lenvatinib
Lemvatinib waa kinase inhibitor badan oo bartilmaameedsan kaas oo xannibi kara dhowr arrimood oo sharci ah oo ay ku jiraan VEGFR1-3, FGFR1-4, PDGFRa, KIT, RET unugyada burooyinka. Febraayo 13, 2015, waxaa ansixiyay FDA inay tahay dib u eegis mudnaan leh iyo agoonta daroogada suuqgeyn sida daawaynta khatarta sare leh ee kansarka qanjirka tayroodhka ee u diida iodine radioactive. May 13, 2016 waxaa ansixiyay FDA oo ay weheliso Afinitor si loogu daweeyo kansarka unugyada kelyaha ee horumarsan oo leh daawadii hore ee anti-VEGF. Calaamadaha kansarka beerka, Eisai wuxuu gudbiyay codsi suuqgeyn gudaha Japan bishii Juun 2017, wuxuu u gudbiyay codsi suuqgeyn EMA iyo FDA bishii Luulyo 2017, wuxuuna u gudbiyay codsi suuqgeyn CFDA Noofambar 3, 2017. Waxaa la helay Diseembar 18, Dib u eegista mudnaanta CDE 2017. FDA waxay siisay u-qalmitaanka daawada agoonta ee lenvaltinib si loo daweeyo kansarka hepatocellular. Waxay aqbashay Eisai's sNDA Sebtembar 27, waxayna samaysay go'aan ogolaansho si waafaqsan nidaamka dib u eegista caadiga ah ee 10 bilood ah, kaas oo la ansixin doono ka hor dhamaadka Luulyo.
12) Ceritinib
Ceritinib waa jiilka labaad ee anaplastic lymphoma kinase (ALK) inhibitor. Waxaa ansixiyay FDA bishii Abriil 29, 2014 crizotinib ee loogu talagalay dulqaad la'aanta ama horumarka cudurka ALK + kansarka sambabada unugyada aan yareyn, 2017. May 26 FDA waxay ansixisay daaweynta safka hore ee ALK + kansarka sambabada unugyada unugyada yaryar. Codsiga liiska kaabsoosha ee Novartis ceritinib waxaa si rasmi ah u aqbashay CDE December 11, 2017. Waa in lagu daraa dib u eegista mudnaanta dambe (codsiyada caafimaadku waxay heleen dib u eegis mudnaan leh). Waxa la filayaa in ay ansixiso CFDA sanadka 2018Q4. Kuwa kore ayaa soo koobaya daawooyinkii ugu dambeeyay ee daaweynta kansarka. Daawooyinka waxaa si weyn loogu isticmaalaa kansarka sanbabada, kansarka caloosha, kansarka beerka, kansarka naasaha, iyo kansarka ugxansidaha.
