Impumelelo entsha yonyango lonyango lomhlaza womlomo wesibeleko

I-Innovent Biologics, Inc. ibhengeze ukuba iZiko loVavanyo lweZiyobisi (CDE) loLawulo lweeMveliso zoNyango lweSizwe (i-NMPA) linike i-Breakthrough Therapy Designation (BTD) ye-IBI310 ngokudibanisa ne-sintilimab yonyango lwezigulane ezinomhlaza womlomo wesibeleko ophindaphindiweyo okanye we-metastatic.

I-BTD ye-NMPA ye-IBI310 yayisekelwe kwiziphumo ezivela kwinxalenye yokuQala yovavanyo lweSigaba se-2 (i-CDE yoBhaliso No. CTR20202017). Olu phononongo lubhalise izigulane ezingama-205 kwizigulane ezinomhlaza womlomo wesibeleko. Iprofayili yokhuseleko kolu phononongo yayihambelana noko kubonwe kwizifundo ezixelwe ngaphambili, kwaye akukho miqondiso yokhuseleko eyongezelelweyo ichongiwe kwindibaniselwano ye-IBI310 kunye ne-sintilimab. Iziphumo zophononongo ezifanelekileyo ziya kupapashwa kwinkomfa yezonyango ezayo ngo-2022.

"Siyavuya ukubona isibonelelo se-NMPA i-Breakthrough Therapy Designation esekelwe kwiziphumo zecandelo lokuQala leSigaba se-2 sedatha ye-IBI310," watsho uDkt. Hui Zhou, iSekela likaMongameli oPhezulu we-Innovent. “Izigulana ezinomhlaza womlomo wesibeleko okwinqanaba eliphezulu okwangoku zineendlela zonyango ezilinganiselweyo. Izigulana ezinyangwa ngechemotherapy zibonisa uncedo olunyiniweyo lwezonyango kwaye ubomi bubonke bukhawulelwe kwiinyanga ezimbalwa. Iziphumo zeSigaba sokuQala sophononongo lweSigaba sesi-2 se-IBI310 ngokudityaniswa ne-sintilimab zibonakalisa amandla ale ndibaniselwano njengokhetho olutsha lonyango lwezigulane eziludingayo. Sijonge phambili ekufumaneni idatha eyongezelelekileyo kulingo oluqhubekayo lweSigaba se-2 esinokuthi sixhase isicelo solawulo lwexesha elizayo e-China kwi-IBI310 ngokudityaniswa ne-sintilimab kumhlaza womlomo wesibeleko oqhelekileyo okanye ometastatic.

I-NMPA Breakthrough Therapy Designation yenzelwe ukuququzelela nokukhawulezisa uphuhliso kunye nophononongo lwechiza lophando ukunyanga isifo esimandundu okanye imeko xa ubungqina bezonyango bubonisa ukuba ichiza libonakalise ukuphucuka okukhulu kunyango lwangoku. I-BTD ayiyi kufaneleka kuphela umviwa weziyobisi ukuba afumane isimo sokuphononongwa ngokukhawuleza yi-CDE, kodwa iya kuvumela umxhasi ukuba afumane iingcebiso ngexesha elifanelekileyo kunye nonxibelelwano oluvela kwiCDE ukukhawulezisa ukuvunywa kunye nokuqaliswa ukujongana nemfuno yekliniki engafanelekanga yezigulane kwi-CDE. isantya esikhawulezileyo. Cofa apha ukuze ufumane uluhlu olupapashiweyo lwamachiza anikwe i-BTD yi-NMPA.