Pa June 29, 2017, chitukuko cha Laipushutai, kalasi yoyamba ya mankhwala atsopano ndi chitukuko chogwirizana cha JYMed ndi Guangzhou Linkhealth Medical Technology Co., Ltd., chapita patsogolo kwambiri. Chidziwitso cha IND cha mankhwalawa chavomerezedwa ndi CFDA.
JYMed ndi Guangzhou Linkhealth Medical Technology Co., Ltd. adachita mgwirizano mu 2016 kuti agwirizane kupanga mankhwalawa ku China. Mitunduyi yamaliza maphunziro a POC azachipatala ku EU ndipo idapeza chitetezo chabwino komanso chikhululukiro. Onse a FDA ndi EMA amazindikira kuti zamoyozi zitha kugwiritsidwa ntchito pochiza pamzere wa I/II, ndipo kufunikira kudzaperekedwa ku mpumulo ndi chithandizo cha odwala omwe ali ndi matenda am'matumbo am'mimba potsatira mayeso achipatala a CFDA.
Ulcerative colitis (UC) ndi matenda otupa osakhazikika, omwe amapezeka mu rectum ndi colon. Malinga ndi ziwerengero, kuchuluka kwa UC ndi 1.2 mpaka 20.3 milandu / 100,000 munthu pachaka ndipo kuchuluka kwa UC ndi 7.6 mpaka 246.0 milandu / anthu 10,000 pachaka. Zochitika za UC ndizofala kwambiri mwa achinyamata. Msika wa UC uli ndi kuchuluka kwakukulu komanso kufunikira kwa mankhwala, ndipo upitilizabe kukhala ndi kukula kwakukulu mtsogolomo. Pakadali pano, UC woyamba mankhwala amachokera ku mesalazine ndi mahomoni, ndipo mankhwala amtundu wachiwiri amaphatikiza ma immunosuppressants ndi ma biological monoclonal antibodies. Mesalazine ili ndi malonda a 1 biliyoni ku China ndi US $ 2 biliyoni ku United States mu 2015. Laipushutai ali ndi yankho labwino ku zizindikiro za UC, ndipo ndi otetezeka kuposa mankhwala omwe alipo panopa. Ili ndi mwayi wabwino wamsika ndipo ikuyembekezeka kukhala mankhwala oyamba a UC.
Nthawi yotumiza: Mar-02-2019