Ngomhla zingama-29 kuNhlangulana wezi-2017, ukuthuthukiswa kwe-Laipushutai, imithi emisha yekilasi I ngokuthuthuka ngokubambisana kwe-JYMed kanye ne-Guangzhou Linkhealth Medical Technology Co., Ltd., kwenziwe inqubekelaphambili ebonakalayo. Isimemezelo se-IND somuthi samukelwe yi-CFDA.

I-JYMed kanye ne-Guangzhou Linkhealth Medical Technology Co., Ltd. bafinyelela isivumelwano sokubambisana ngo-2016 sokuthuthukisa ngokuhlanganyela lo mkhiqizo eChina. Uhlobo seluphothule izifundo zomtholampilo ze-POC e-EU futhi lwazuza ukuphepha okuhle kanye namazinga okuxolelwa. Kokubili i-FDA kanye ne-EMA bayaqaphela ukuthi lolu hlobo lwezilwane lungasetshenziselwa ukwelashwa emgqeni we-I/II, futhi kuzobekwa kuqala ekusizeni nasekulashweni kweziguli ezine-ulcerative colitis emaphakathi ngokulandela izivivinyo zomtholampilo ze-CFDA.

I-Ulcerative colitis (UC) isifo sokuvuvukala esingamahlalakhona, esingaqondile esenzeka ku-rectum kanye nekholoni. Ngokwezibalo, izinga lezigameko ze-UC liyi-1.2 kuya ku-20.3 amacala / umuntu we-100,000 ngonyaka kanye nokusabalala kwe-UC ku-7.6 kuya ku-246.0 amacala / abantu abangu-10,000 ngonyaka. Isigameko se-UC sivame kakhulu kubantu abadala. Imakethe ye-UC inezinga elikhulu nesidingo sezidakamizwa, futhi izoqhubeka nokugcina ukuthambekela kokukhula okuphezulu esikhathini esizayo. Kuze kube manje, umuthi womugqa wokuqala we-UC usekelwe ikakhulukazi ku-mesalazine namahomoni, futhi izidakamizwa zomugqa wesibili zihlanganisa ama-immunosuppressants kanye namasosha omzimba we-biological monoclonal. I-Mesalazine inomthamo wokuthengisa we-1 billion e-China kanye ne-US $ 2 billion e-United States ngo-2015. I-Laipushutai inempendulo engcono kuzimpawu ze-UC, futhi iphephile kunezidakamizwa zamanje zomugqa wokuqala. Inenzuzo enhle yemakethe futhi kulindeleke ukuthi ibe umuthi wokuqala we-UC.