Kamfanin CStone Pharmaceuticals a yau ya sanar da cewa, Hukumar Kula da Kayayyakin Kiwon Lafiya ta kasar (NMPA) ta kasar Sin ta amince da karin sabon aikace-aikacen magani (sNDA) na zabin mai hanawa RET GAVRETOยฎ (pralsetinib) don maganin ciwon daji na thyroid na RET-mutant medullary thyroid cancer (MTC) da RET fusion - Ciwon daji na thyroid (TC). Yarjejeniyar ta fadada alamun GAVRETO a kasar Sin don haษawa da manya da marasa lafiya na yara masu shekaru 12 da haihuwa tare da ci gaba ko haษakaccen RET-mutant MTC wanda ke buฦatar tsarin kulawa, da kuma manya da yara masu shekaru 12 da haihuwa tare da ci gaba ko haษakawa. RET fusion-tabbatacce TC wanda ke buฦatar tsarin tsarin jiyya da rediyoaktif iodine-refractory (idan maganin rediyoaktif iodine ya dace).
An gano ta abokin tarayya na CSstone Magungunan Blueprint, GAVRETO mai ฦarfi ne kuma mai hanawa na RET. CSstone yana da haษin gwiwa na musamman da yarjejeniyar lasisi tare da Magungunan Blueprint don haษakawa da kasuwancin GAVRETO a cikin Babban China, wanda ya ฦunshi Mainland China, Hong Kong, Macau da Taiwan.
Dr. Frank Jiang, shugaban da Shugaba na CSstone, ya ce, "Muna matukar farin ciki game da amincewar sNDA na GAVRETO, wanda zai ba da sabon zaษin magani ga marasa lafiya na kasar Sin masu ciwon daji na RET-mutant medullary thyroid cancer da RET fusion-positive thyroid cancer. . Muna kuma son mika godiya ta musamman ga NMPA don bitar fifiko. CStone koyaushe yana da himma don haษaka sabbin hanyoyin kwantar da hankali don magance buฦatun likitancin marasa lafiya na masu cutar kansa. Za mu ci gaba da inganta kimar asibiti da yuwuwar bututunmu, da kuma kara kaimi wajen samarwa marasa lafiya a duk duniya magunguna masu inganci da sabbin fasahohi."
Farfesa Ming Gao, babban mai bincike na binciken ARROW kuma shugaban Cibiyar Kiwon Lafiya ta Tianjin Union, ya ce, โYawan kamuwa da cutar kansar thyroid yana karuwa a cikin 'yan shekarun nan. Akwai iyakatattun zaษuษษukan magani na asibiti don maganin MTC, kuma akwai buฦatar gaggawa don ainihin hanyoyin kwantar da hankali, musamman ga marasa lafiya tare da RET-mutant MTC. GAVRETO ya nuna aiki mai ฦarfi da ษorewa na rigakafin ฦwayar cuta a cikin marasa lafiyar Sinawa tare da ci gaba ko haษaka RET-mutant MTC, tare da amincin gabaษaya daidai da sakamakon da aka gani a cikin binciken ARROW na duniya. Tare da wannan fadada alamomin GAVRETO, muna sa ido don magance rashin biyan buฦatun asibiti na masu cutar kansar thyroid."
Dokta Jason Yang, babban jami'in kula da lafiya na CSstone, ya ce, "Yin amincewa da NMPA na sNDA wani muhimmin ci gaba ne a gare mu bayan GAVRETO da aka amince da shi don kula da marasa lafiya da ke cikin gida ko kuma ciwon daji na RET. . Muna so mu gode wa duk marasa lafiya da masu bincike waษanda suka ba da gudummawa ga binciken asibiti na GAVRETO a cikin faษaษa alamun. Za mu ci gaba da haษaka bincike na asibiti na GAVRETO don magance nau'ikan cututtukan daji da yawa ta yadda za mu iya gabatar da wannan sabbin hanyoyin da sauri don taimakawa ฦarin fa'ida ga marasa lafiya. "
Amincewar sNDA ta dogara ne akan sakamako daga gwaji na 1/2 ARROW na duniya, wanda aka ฦera don kimanta aminci, haฦuri da ingancin GAVRETO a cikin marasa lafiya tare da RET fusion-positive NSCLC, RET-mutant MTC, da sauran ciwace-ciwacen ciwace-ciwace tare da fusions na RET. . Ya zuwa ranar da za a yanke bayanai na Afrilu 12, 2021, jimillar marasa lafiya 28 da ke da ci gaba na RET-mutant MTC sun yi rajista a cikin rukunin rajista na MTC na China na binciken ARROW na duniya, kuma sun sami fara GAVRETO kashi 400 MG sau ษaya kowace rana. Sakamakon binciken ya nuna cewa ฦimar amsawar haฦiฦa (ORR) na 26 RET-mutant MTC marasa lafiya tare da cututtukan da za a iya aunawa a asali shine 73.1%, gami da 3 tare da cikakkiyar amsa (CR) da 16 tare da amsoshi kaษan (PR). Adadin kula da cututtuka (DCR) ya kasance 84.6%, kuma an lura da martani ba tare da la'akari da maye gurbi na RET ba. Daga cikin marasa lafiya na 19 da aka tabbatar da amsa, ba a kai ga tsawon lokacin amsawa ba (DOR), kuma adadin DOR na watanni 9 ya kasance 100%. Calcitonin da carcinoembryonic antigen (CEA) an rage sosai. GAVRETO gabaษaya an yi haฦuri da kyau, ba tare da sabon siginar aminci da aka gano ba. An gabatar da sakamakon gamayyar masu yin rajistar kasar Sin a yayin wani zaman taro na shekara-shekara karo na 90 na kungiyar thyroid ta Amurka (ATA) 2021.
