Ngo-June 29, 2017, ukuthuthukiswa Laipushutai, isigaba mina imithi ezintsha ukuthuthukiswa wokubambisana JYMed futhi Guangzhou Linkhealth Medical Technology Co., Ltd., esenze intuthuko ephawulekayo. IND isimemezelo izidakamizwa sesamukelwe le CFDA.
JYMed futhi Guangzhou Linkhealth Medical Technology Co., Ltd. ifinyelele esivumelwaneni nobambiswano 2016 ukuze ngokuhlanganyela ukuthuthukisa lo mkhiqizo in China. Lezi zilwane kuqede POC izifundo zokwelapha e-EU futhi nemiphumela emihle ukuphepha ukuthethelelwa amazinga. Bobabili i-FDA kanye EMA ukuthi lokhu zilwane singasetshenziswa for ukwelashwa ku-I / II umugqa, futhi igunya uyonikwa impumuzo kanye nokwelashwa kweziguli ngokulinganisela izilonda emathunjini e omlandelayo zokwelapha of CFDA.
izilonda emathunjini (UC) kuyinto okungamahlalakhona, non-ethize isifo ukuvuvukala ukuthi kwenzeka ingemuva kanye ikholoni. Ngokwezibalo, izinga kwesifo UC kuyinto amacala 1.2 kuya 20.3 / 100,000 umuntu ngamunye ngonyaka nokudlanga UC kuyinto amacala 7.6 kuya 246,0 / abantu 10,000 ngonyaka. Izigameko zokushona UC landile nentsha. I UC emakethe has ngezinga elikhulu futhi ukufunwa izidakamizwa, futhi uzoqhubeka ulondoloza okusezingeni eliphezulu ukukhula mkhuba esikhathini esizayo. Kuze kube manje, UC lokuqala umugqa izidakamizwa ngokuyinhloko esekelwe mesalazine kanye amahomoni, izidakamizwa lesibili umugqa zihlanganisa immunosuppressants nezinto eziphilayo amasosha omzimba monoclonal. Mesalazine has a umthamo yokuthengisa 1 bhiliyoni eChina US $ 2 billion ngonyaka e-United States ngo-2015 Laipushutai has impendulo engcono UC izimpawu, futhi kuphephile kuka wamanje lokuqala yomugqa. It has a inzuzo enhle emakethe futhi kulindeleke ukuba abe lokuqala umugqa UC izidakamizwa.
isikhathi Iposi: Mar-02-2019
