Finotonlimab inotenderwa kushandiswa mukurapa squamous cell carcinoma yemusoro nemutsipa

Musi wa8 Kukadzi, 2025, National Medical Products Administration (NMPA) yeChina yakabvumidza finotonlimab yeSinocelltech Group Ltd, mushonga we programmed-death 1 (PD-1) monoclonal antibody (mAb), kuti ushandiswe pamwe chete ne platinum-based chemotherapy senzira yekutanga yekurapa recurrent uye/kana metastatic squamous cell carcinoma yemusoro nemutsipa.

Finotonlimab iantibody yerudzi rweIgG4 ine simba rehumanized anti-PD-1 monoclonal ine kodzero dzakakwana dzepfungwa. Semushonga mutsva une patent, chimiro chayo chemamorekuru chakasiyana uye chine zvakanakira mashandiro ayo. Finotonlimab inobatanidza PD-1 nehukama hwakasimba, ichinyatsovhara nzira yePD-1/PD-L1, ichidzorera nekusimudzira mashandiro ekuuraya masero eT, uye nokudaro ichidzivisa kukura kwebundu.

AKuedzwa kwechikamu chechitatu kwakarongwa, kwakaongororwa kushanda uye kuchengetedzeka kwefinotonlimab (SCT-I10A), iyo antibody yekufa kwemasero 1 (PD-1) monoclonal, yakasanganiswa necisplatin pamwe ne5-fluorouracil (C5F) yekurapa kwekutanga kweR/M HNSCC. Varwere vanokodzera (n = 370) vakagoverwa zvisina tsarukano 2:1 kuti vagamuchire finotonlimab pamwe neC5F (n = 247) kana placebo pamwe neC5F (n = 123). Mugumo wekutanga waive wekurarama kwese (OS). Muboka refinotonlimab pamwe neC5F, OS yaive mwedzi 14.1 (95% confidence interval (CI) 11.1–16.4), zvichienzaniswa nemwedzi 10.5 (95% CI 8.1–11.8) muboka replacebo pamwe neC5F. Chiyero chengozi chaive 0.73 (95% CI 0.57–0.95, P = 0.0165), zvichisangana nezvinodiwa zvakatarwa zvehukuru hwekutanga. Finotonlimab pamwe neC5F yakaratidza hukuru hweOS hwakakura zvichienzaniswa neC5F chete uye hunhu hwekuchengetedza hunogamuchirwa neR/M HNSCC, zvichitsigira kushandiswa kwayo senzira yekutanga yekurapa R/M HNSCC. Mhedzisiro iyi inosimbisa kushanda uye kuchengetedzeka kwemusanganiswa wefinotonlimab neC5F muvarwere vekuAsia vane R/M HNSCC.

Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.

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Mareferensi

1.国家药品监督管理局 (nmpa.gov.cn)

2.Finotonlimab ine chemotherapy mukenza yemusoro nemutsipa inodzokororwa kana kuti inopararira: bvunzo yechikamu chechitatu isina kurongeka | Nature Medicine