Musi waGumiguru 13, vanhu vanopfuura zana nemakumi masere vanobva muindasitiri yekutsvagisa nekusimudzira yekurwisa antibody vakaungana muChengdu Hall yeShanghai Hope Hotel.Vadzidzisi gumi kubva muindasitiri yekutsvakurudza nekusimudzira mishonga yekurwisa zvirwere uye masangano ekutsvagisa sainzi akaunzawo kugovana kunoshamisa.
Kutanga kubva papfungwa nekushandiswa kwemasoja ekudzivirira chirwere, Dr. Zhang Aihua vakakurukura kurongwa uye mazita emishonga inorwisa masoja.Tichitora CD47 semuenzaniso, Dr. Zhang vakatsanangura pamusoro pemaitirwo echiito uye kushandiswa kwekiriniki kwemishonga inorwisa masoja.Parizvino, kutsvagisa nekuvandudzwa kwemamonoclonal antibodies kuri kupisa zvakanyanya.Mukuita budiriro, tinofanira kusiyanisa mutsauko uripo pakati pekugadzirwa kwemasoja ekudzivirira chirwere uye kutonga kwemhando yeBiosimilar.Mukugadzirwa kwemishonga yeutsva, tsvakiridzo yemhando yakakwana inofanirwa kuitwa zvinoenderana neruzivo rwekusimudzira rwemhando kubva mukugadzira (QbD) uye musimboti wekuchengetedza, kushanda, uye kuve nehunhu hunodzoreka.
Dr. Wang Gang, mukuru wesainzi, aive nebasa rekuteedzera nekuongorora paCFDA Drug Review Center (CDE).Akaunza hurongwa hweHurumende Drug Administration yeChina, inova matatu-tier hurongwa hwemitemo, mirau, uye tekinoroji nhungamiro yeHurumende Drug Administration.Akazivisawo maitiro ekunyoreswa uye kubvumidzwa kweChina Biological Products Licensing Application (BLA) uye New Drug Application (NDA).Akasimbisa kuti kuvandudzwa kwekutonga, mutemo, uye nzira dzemvumo yezvinodhaka yeHurumende Drug Administration ichasimudzira zvikuru kugadzirwa kwemishonga mitsva muChina, uye inoenzanisa hurongwa hwekuongorora manejimendi yeFood and Drug Administration yeEurope neUnited States.Pakupedzisira, akaratidza maonero ake kune remangwana shanduko yeChina yemishonga inodzora system.Dr. Wang vakatitungamirira kuti tiongorore mutemo chaiwo wezvakagadziridzwa kuDrug Administration Law yePeople's Republic of China uye kuMitemo yeDrug Registration and Administration, uye maitiro avo anosvika kure muindasitiri yemishonga yeR & D mumakore achangopfuura.
Iyo yakazvigadzira yega Counttar Rigel naALIT Hupenyu Sayenzi yakanakira chiitiko chehunyanzvi uye chegoridhe seizvi.Countstar Altair yakanyatsogadzirirwa iyi indasitiri.Yayo data manejimendi uye kutonga kuita kunoenderana zvizere neFDA 21 CFR Chikamu11.Iyo zvakare inokwanisa kupa 3Q yekusimbisa masevhisi kune akasiyana akajairwa magranules ekusimbisa.Iyo inogadzirisa zvachose kushushikana kwevatengi veindasitiri nezvekutonga kwemhando.
Panzvimbo yemusangano, nyanzvi dzakawanda dzeindastiri dzakauya kuzotaurirana nekukurukura, uye munhu wese akabvumirana nekuita kwaRigel uye kutevedzera.Countstar icharamba ichitsigira kuomarara uye kungwarira maitiro esainzi, kugara ichivandudza, uye kubatsira indasitiri yeantibody kuve nebudiriro iri nani.
Countstar Altair inopa prototype yekuedza sevhisi, uye inogamuchira munhu wese kunyorera!
