A ranar 25 ga Afrilu, 2025, InnoCare Pharma ta sanar da cewa Cibiyar Kimanta Magunguna (CDE) ta Hukumar Kayayyakin Lafiya ta Kasa (NMPA) ta ba wa sabon ƙarni na pan-TRK mai hana zurletrectinib (ICP-723) damar yin bita kan sabon ƙarni na pan-TRK mai hana zurletrectinib (ICP-723), wanda ya amince da Sabon Amfani da Zurletrectinib don maganin marasa lafiya da ke fama da ciwon daji masu ƙarfi waɗanda ke ɗauke da haɗin kwayoyin halitta na NTRK kwanan nan. Bitar fifiko ita ce ɗaya daga cikin manyan manufofin da CDE ta gabatar don hanzarta amincewa da magani.
A cikin gwajin rajista ga marasa lafiya da ke fama da ciwon daji na NTRK, zurletrectinib ya nuna kyakkyawan tasiri tare da kyakkyawan bayanin tsaro.
Dr. Jasmine Cui, wacce ta kafa InnoCare, shugabar kamfanin kuma babbar jami'ar gudanarwa, ta ce, "Muna matukar farin ciki da aka ba wa zurletrectinib fifiko. Zurletrectinib ya nuna kyakkyawan inganci da kuma kyakkyawan yanayin tsaro. Muna sa ran zai samar da ingantattun hanyoyin magani ga marasa lafiya da suka cancanta da ciwon daji mai ƙarfi tun da wuri."
Zurletrectinib wani maganin hana ciwon daji ne da InnoCare ta ƙirƙiro. Jaridar British Journal of Cancer, wani ɓangare na mujallar kimiyya mai suna Nature, ta buga wata takarda mai taken "Zurletrectinib wani maganin hana ciwon daji ne na ƙarni na gaba wanda ke da ƙarfin aikin intracranial akan ciwon daji na NTRK wanda ke da juriya ga magungunan ƙarni na farko".
Jaridar ta nuna cewa zurletrectinib ya nuna ƙarfi mai ƙarfi akan kinases na TRKA, TRKB, da TRKC WT, da kuma maye gurbi na juriya da aka samu na TRKA G595R da TRKA G667C. Zurletrectinib ya fi ƙarfin aiki fiye da sauran masu hana TRK na ƙarni na farko da FDA ta amince da su ko kuma waɗanda aka gwada a asibiti (larotrectinib) da kuma na gaba (selitrectinib da repotrectinib) waɗanda suka yi maganin yawancin maye gurbi na juriya na TRK. Hakazalika, zurletrectinib (1 mg/kg BID) ya hana ci gaban ƙari a cikin samfuran xenograft da aka samo daga ƙwayoyin haɗin NTRK masu kyau a kashi sau 30 ƙasa da na selitrectinib.
Takardar ta ƙara nuna cewa, a cikin wani bincike da aka yi kan pharmacokinetic na tsarin jijiyoyi na tsakiya (CNS) a cikin berayen SD, zurletrectinib ya nuna ingantaccen ikon shiga shingen jini-kwakwalwa, yana isa ga kwakwalwa yadda ya kamata fiye da selitrectinib da repotrectinib. Ƙara shigar kwakwalwa ta Zurletrectinib shi ma an fassara shi zuwa ingantaccen aikin hana ƙari. A cikin samfurin glioma xenograft na linzamin kwamfuta mai kama da orthotopic wanda ke ɗauke da maye gurbi na juriya na TRKA G598R/G670A, zurletrectinib (15 mg/kg) ya inganta rayuwar beraye masu ɗauke da gliomas na orthotopic NTRK fusion-positive, TRK-mutant gliomas (tsakanin rayuwa = 41.5, 66.5, da kwanaki 104 don selitrectinib, repotrectinib, da zurletrectinib bi da bi; P < 0.05), yana nuna inganci mafi kyau idan aka kwatanta da repotrectinib (15 mg/kg) da seletrectinib (30 mg/kg) (P=0.0384 da 0.0022, bi da bi), tare da kyakkyawan bayanin aminci.
Kwayoyin halittar NTRK suna faruwa a cikin nau'ikan ciwon daji na manya da yara daban-daban. A wasu nau'ikan ciwon daji da ba kasafai ake samu ba, kamar ciwon daji na glandar salivary, ciwon nono na secretory, da kuma fibrosarcoma na jarirai, yawan kamuwa da ciwon daji na NTRK ya wuce kashi 90%. An kiyasta cewa ana gano sabbin kamuwa da cutar NTRK guda 6,500 a kowace shekara a kasar Sin. Akwai manyan bukatu na asibiti da ba a cika ba a wannan fanni saboda rashin ingantattun hanyoyin magani.
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
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Lokacin Saƙo: Mayu-07-2025