Anti-PD-L1 (Tagitanlima) Yalandira Chilolezo cha NMPA cha Kutsatsa

Pa Disembala 31, 2024, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kampani") yalandira chilolezo chotsatsa ku China kuchokera ku National Medical Products Administration (NMPA) cha antibody yatsopano ya monoclonal yoyendetsedwa ndi programmed cell death ligand1(PD-L1) ("mAb") tagitanlimab (yomwe kale inali KL-A167) (科泰莱®) yochizira odwala omwe ali ndi khansa ya m'mphuno yobwerezabwereza kapena yofalikira (NPC) omwe adalephera pambuyo pa chemotherapy ya 2L+. Iyi ndi antibody yoyamba padziko lonse ya PD-L1 monoclonal yovomerezedwa kuti ichitikire NPC.

Kuvomerezedwa kumeneku kumachokera ku kafukufuku wachipatala wa gawo lachiwiri la mkono umodzi, la malo ambiri, mwa odwala omwe ali ndi NPC yobwerezabwereza kapena yofalikira omwe adalephera pambuyo pa chithandizo chamankhwala cha 2L+ m'mbuyomu, motsogozedwa ndi Pulofesa Shi Yuankai wa Cancer Hospital Chinese Academy of Medical Sciences monga wofufuza wamkulu, kuti awone momwe tagitanlimab monotherapy imagwirira ntchito komanso momwe imatetezera.

Pakati pa February 26, 2019 ndi Januware 13, 2021, odwala 153 adalandira chithandizo. Odwala onse 132 adalowa mu seti yonse yowunikira (FAS) ndipo adawunikidwa kuti awone ngati ikugwira ntchito bwino. Pofika tsiku lomaliza la deta pa Julayi 13, 2021, nthawi yapakati yowunikira inali miyezi 21.7 (95%CI 19.8–22.5). Kwa anthu a FAS, ORR yoyesedwa ndi IRC inali 26.5% (95%CI 19.2–34.9%), ndipo chiwongola dzanja chowongolera matenda (DCR) chinali 56.8% (95%CI 47.9–65.4%). Kupulumuka kosapitirira muyeso (PFS) kwapakati kunali miyezi 2.8 (95%CI 1.5–4.1). Nthawi yapakati yoyankhira inali miyezi 12.4 (95%CI 6.8–16.5), ndipo yapakati yopulumuka (OS) inali miyezi 16.2 (95%CI 13.4–21.3).

Zokhudza NPC

Deta ya GLOBOCAN ya 2022 inasonyeza kuti panali milandu yatsopano yoposa 120,000 ya khansa ya m'mphuno padziko lonse lapansi, milandu yatsopano 51,000 ya khansa ya m'mphuno ndi imfa 28,400 ku China. Malinga ndi malangizo a CSCO a 2021, njira yothandizira khansa ya m'mphuno ya 1L yomwe singathe kuchiritsidwa m'deralo imachokera ku mankhwala ophatikizana okhala ndi platinum, ndipo chithandizo cha 2L chimachokera ku monotherapy. Chiwerengero cha odwala omwe ali ndi khansa ya m'mphuno ya ...

About Tagitanlima

Tagitanlima, yopangidwa ndi Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (Chengdu, China), ndi antibody ya IgG1κ monoclonal yopangidwa ndi munthu yomwe imayang'ana PD-L1 yomwe imaletsa kuyanjana kwa PD-L1 ndi PD-1.

Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.

Nambala ya Foni: 4008803716

Imelo：myimmnet@163.com

Zolemba

1.Ukadaulo ndi Mapaipi a Zinthu – Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

2.国家药监局批准塔戈利单抗注射液上市 (nmpa.gov.cn)

3.Kugwira ntchito bwino ndi chitetezo cha KL-A167 mu khansa ya m'mphuno yomwe idachiritsidwa kale kapena yofalikira: kafukufuku wa multicenter, single-hand, phase 2 - The Lancet Regional Health - Western Pacific

4.Chen YP, Chan ATC, Le QT, Blanchard P, Sun Y, Ma J. Khansa ya m'mphuno. Lancet (London, England) 2019;394(10192):64–80. doi: 10.1016/S0140-6736(19)30956-0.