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.
INTO ONOKUYITHATHA KWELI NQAKU:
- The BTD will not only qualify a drug candidate to receive status for rapid review by the CDE, but it will also allow the sponsor to obtain timely advice and communication from the CDE to accelerate the approval and launch to address the unmet clinical need of patients at an accelerated pace.
- The results of First part of the Phase 2 study of IBI310 in combination with sintilimab show potential for this combination as a new treatment option for patients in need.
- announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI310 in combination with sintilimab for the treatment of patients with recurrent or metastatic cervical cancer.
