NgoJuni 29, i-2017, ukuphuhliswa kweLaipushutai, iklasi I iyeza ezintsha kunye nophuhliso lwentsebenziswano ye-JYMed kunye ne-Guangzhou Linkhealth Medical Technology Co., Ltd., yenze inkqubela phambili enkulu. Isibhengezo se-IND yechiza samkelwe yi-CFDA.

I-JYMed kunye ne-Guangzhou Linkhealth Medical Technology Co., Ltd. ifikelele kwisivumelwano sentsebenziswano kwi-2016 ukuphuhlisa ngokudibeneyo le mveliso e-China. Iintlobo ziye zagqiba izifundo zeklinikhi ze-POC kwi-EU kwaye zafumana ukhuseleko oluhle kunye namazinga okuxolelwa. Zombini i-FDA kunye ne-EMA ziyaqaphela ukuba olu hlobo lunokusetyenziswa kunyango kumgca we-I/II, kwaye okuphambili kuya kunikwa isiqabu kunye nonyango lwezigulane ezine-ulcerative colitis ephakathi ekulandeleni iimvavanyo zekliniki ze-CFDA.

I-Ulcerative colitis (UC) sisifo esingapheliyo, esingenasifo esicacileyo esenzeka kwi-rectum kunye ne-colon. Ngokwezibalo, izinga leziganeko ze-UC yi-1.2 ukuya kwi-20.3 iimeko / i-100,000 umntu ngonyaka kwaye ukuxhaphaka kwe-UC yi-7.6 kwi-246.0 iimeko / abantu abayi-10,000 ngonyaka. Iziganeko ze-UC zixhaphake kakhulu kubantu abadala abancinci. Imakethi ye-UC inomlinganiselo omkhulu kunye nemfuno yamachiza, kwaye iya kuqhubeka nokugcina ukukhula okuphezulu kwixesha elizayo. Ukuza kuthi ga ngoku, ichiza lokuqala le-UC lisekelwe ikakhulu kwi-mesalazine kunye neehomoni, kwaye amachiza odidi lwesibini aquka amachiza akhusela umzimba kunye ne-biological monoclonal antibodies. I-Mesalazine inomthamo wokuthengisa we-1 yebhiliyoni e-China kunye ne-US $ 2 yebhiliyoni e-United States kwi-2015. I-Laipushutai inempendulo engcono kwiimpawu ze-UC, kwaye ikhuselekile kunamachiza akhoyo angoku. Inenzuzo entle yentengiso kwaye kulindeleke ukuba ibe lichiza le-UC lodidi lokuqala.