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Sabuwar nadi nadi na maganin cutar kansar mahaifa

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Innovent Biologics, Inc. ya sanar da cewa, Cibiyar Nazarin Magunguna (CDE) na Hukumar Kula da Kayayyakin Kiwon Lafiya ta kasar Sin (NMPA) ta ba da lambar yabo ta Breakthrough Therapy Designation (BTD) don IBI310 tare da sintilimab don kula da marasa lafiya da ke fama da ciwon daji na mahaifa ko mai tsanani.

NMPA BTD na IBI310 ya dogara ne akan sakamako daga ɓangaren Farko na gwaji na Mataki na 2 (Rijistan CDE No. CTR20202017). Wannan binciken ya shigar da marasa lafiya 205 a cikin marasa lafiya da ciwon daji na mahaifa. Bayanan aminci a cikin wannan binciken ya kasance daidai da abin da aka gani a cikin binciken da aka ruwaito a baya, kuma ba a gano ƙarin alamun tsaro don haɗuwa da IBI310 da sintilimab ba. Za a buga sakamakon binciken da ya dace a taron likita mai zuwa a cikin 2022.

"Mun yi farin cikin ganin NMPA na samar da kayan kwalliya na kwarewa dangane da sakamakon farkon lokaci na Ibi2," in ji Dr. Hui310, Babban Mataimakin Shugaban kasar Ind Onovent. “Masu fama da ciwon daji na mahaifa a halin yanzu suna da iyakataccen zaɓin magani. Marasa lafiya da aka yi amfani da su tare da chemotherapy suna nuna iyakacin fa'idar asibiti kuma gabaɗayan rayuwa yana iyakance ga ƴan watanni. Sakamakon Sashe na Farko na Nazarin Mataki na 2 na IBI310 a hade tare da sintilimab yana nuna yiwuwar wannan haɗin gwiwa a matsayin sabon zaɓi na magani ga marasa lafiya da ke bukata. Muna sa ran samun ƙarin bayanai daga gwaji mai mahimmanci na Mataki na 2 mai gudana wanda zai iya tallafawa aikace-aikacen tsari na gaba a China don IBI310 a hade tare da sintilimab a cikin ciwon daji na mahaifa mai maimaita ko metastatic.

NMPSA Bangaren Yarjejeniyar Yarjejeniyar Yarjejeniya ne don sauƙaƙa da haɓaka ci gaba da sake duba maganin bincike ya nuna cewa ƙwayoyin cuta na farko sun nuna ci gaba sosai game da aikin asibitoci na yanzu. BTD ba kawai zai cancanci ɗan takarar miyagun ƙwayoyi don karɓar matsayi don saurin bita ta CDE ba, amma kuma zai ba da damar mai ba da tallafi don samun shawarwari na lokaci da sadarwa daga CDE don haɓaka yarda da ƙaddamarwa don magance rashin cika buƙatun asibiti na marasa lafiya a. wani hanzarin taki. Danna nan don jerin magungunan da aka buga waɗanda NMPA ta ba BTD.

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Edita a shugaba na eTurboNew ita ce Linda Hohnholz. Ta dogara ne a HQ eTN a Honolulu, Hawaii.

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