Anti-PD-L1 (Tagitanlima) Ya Sami Amincewar NMPA don Talla

Disamba 31, 2024, Kamfanin Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kamfanin") ya sami izinin tallatawa a China daga Hukumar Kayayyakin Lafiya ta Kasa (NMPA) don maganin ligand1 (PD-L1) wanda aka tsara don mutuwar ƙwayoyin halitta ("mAb") tagitanlimab (wanda a da ake kira KL-A167) (科泰莱®) don maganin marasa lafiya da ke fama da cutar kansa ta nasopharyngeal mai dawowa ko kuma metastatic (NPC) waɗanda suka gaza bayan chemotherapy na 2L+ da suka gabata. Wannan shine maganin rigakafi na monoclonal na farko na PD-L1 da aka amince da shi don maganin NPC.

Amincewar ta dogara ne akan wani bincike na asibiti na hannu ɗaya, mai cibiya da yawa, mataki na biyu a kan marasa lafiya da ke fama da NPC mai maimaitawa ko kuma wanda ya kamu da cutar, waɗanda suka gaza bayan jiyya mai inganci na L2+ a baya, ƙarƙashin jagorancin Farfesa Shi Yuankai na Kwalejin Kimiyyar Lafiya ta Asibitin Cancer ta China a matsayin babban mai bincike, don tantance inganci da amincin maganin tagitanlimab.

Tsakanin 26 ga Fabrairu, 2019 da 13 ga Janairu, 2021, an yi wa marasa lafiya 153 magani. Gabaɗaya, marasa lafiya 132 sun shiga cikakken saitin bincike (FAS) kuma an kimanta su don ingancinsu. Tun daga ranar yanke bayanai a ranar 13 ga Yuli, 2021, matsakaicin lokacin bin diddigin shine watanni 21.7 (95%CI 19.8–22.5). Ga yawan FAS, ORR da IRC ta tantance shine 26.5% (95%CI 19.2–34.9%), kuma ƙimar kula da cututtuka (DCR) shine 56.8% (95%CI 47.9–65.4%). Matsakaicin rayuwa ba tare da ci gaba ba (PFS) shine watanni 2.8 (95%CI 1.5–4.1). Matsakaicin tsawon lokacin amsawar shine watanni 12.4 (95% CI 6.8–16.5), kuma matsakaicin tsawon rayuwa (OS) shine watanni 16.2 (95% CI 13.4–21.3).

Game da NPC

Bayanan GLOBOCAN na shekarar 2022 sun nuna cewa akwai sabbin mutane sama da 120,000 da suka kamu da cutar kansar nasopharyngeal a duniya, sabbin mutane 51,000 da suka kamu da cutar kansar nasopharyngeal da kuma mutane 28,400 da suka mutu a kasar Sin. Dangane da ka'idojin CSCO na shekarar 2021, tsarin maganin cutar kansar nasopharyngeal mai saurin yaduwa ko kuma mai saurin yaduwa wanda ba za a iya magancewa a gida ba ya dogara ne akan hadadden maganin chemotherapy mai dauke da platinum, kuma maganin nasopharyngeal mai tsawon rai na shekaru 5 ya dogara ne akan maganin daya. Adadin rayuwa na shekaru 5 ga marasa lafiya da suka kamu da cutar kansar nasopharyngeal mai saurin yaduwa ko mai saurin yaduwa shine kashi 18.5%, tare da matsakaicin tsarin aiki na watanni 22.1, kuma har yanzu akwai bukatar asibiti da ba a cika ba don inganta fa'idar asibiti ga wannan rukunin marasa lafiya, musamman wadanda suka kamu da cutar kansar nasopharyngeal bayan magani. A cikin 'yan shekarun nan, tsarin garkuwar jiki ya samar da ƙarin zaɓuɓɓukan magani ga masu fama da cutar kansar nasopharyngeal kuma ya zama hanya mai inganci don magance marasa lafiya da ke fama da cutar kansar nasopharyngeal.

Game da Tagitanlima

Tagitanlima, wanda Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (Chengdu, China) ke kera, wani cikakken maganin rigakafi ne na IgG1κ monoclonal wanda ke nufin PD-L1 wanda ke toshe hulɗar PD-L1 da PD-1 da kansa.

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.

Lambar Waya: 4008803716

Imel:myimmnet@163.com

Nassoshi

1.Fasaha da Bututun Samfura – 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.Inganci da amincin KL-A167 a cikin cutar kansa ta nasopharyngeal da aka yi wa magani a baya: wani bincike na mataki na 2 - Lafiya ta Yankin Lancet - Western Pacific

4.Chen YP, Chan ATC, Le QT, Blanchard P, Sun Y, Ma J. Ciwon daji na Nasopharyngeal. Lancet (London, Ingila) 2019;394(10192):64–80. doi: 10.1016/S0140-6736(19)30956-0.