Amincewa don Sabbin Ciwon Ciwon Ciwon Ciwon Ciwon Ciki da Ƙwararrun Ƙwararru marasa Hodgkin

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Written by Linda Hohnholz

Kamfanin Antengene Corporation Limited a yau ya sanar da cewa Hukumar Kula da Kayayyakin Kiwon Lafiyar Jama'a ta kasar Sin (NMPA) ta amince da binciken Phase I na ATG-101 (nazarin PROBE-CN) don maganin ciwace-ciwacen ciwace-ciwace da ciwace-ciwace da B-cell wadanda ba Hodgkin lymphoma ba (B). - NHL).

ATG-101 labari ne na bispecific antibody wanda aka ƙera don toshe ɗaurin immunosuppressive PD-1/PD-L1 kuma yana haifar da haɓakar yanayin 4-1BB, don haka yana kunna tasirin rigakafin ƙwayar cuta, yayin isar da ingantattun ayyukan rigakafin ƙari, tare da ingantaccen bayanin martaba. A cikin bincike na yau da kullun, ATG-101 ya nuna babban aikin rigakafin ƙwayar cuta a cikin samfuran dabbobi na ciwace-ciwacen daji da waɗanda suka ci gaba akan maganin anti-PD-1/L1. Bugu da ƙari, ATG-101 ya kuma nuna ingantaccen bayanin martaba a cikin nazarin toxicology na GLP.

Asibitin Gabas ta Shanghai na jami'ar Tongji ne ya jagoranci binciken, wanda za a gudanar a cibiyoyi hudu a fadin kasar Sin. Wannan buɗaɗɗen lakabin, nazari na Multicenter Phase I an tsara shi don tantance aminci da jurewa na ATG-101 monotherapy da aka yi amfani da shi ta hanyar jijiya a cikin marasa lafiya da ciwace-ciwacen ciwace-ciwacen ƙwayar cuta / metastatic da B-NHL. Za a gudanar da binciken a cikin sassa biyu (ƙarashin kashi-kashi da haɓaka kashi).

Farfesa Ye Guo, Mataimakin Darakta na Likita Oncology a Asibitin Gabas ta Shanghai na Jami'ar Tongji, Darakta na cibiyar gwaji na mataki na farko na asibitin, kuma babban mai binciken binciken, ya yi sharhi: "Cutar da ke da juriya ko kuma ta ki yarda da daidaitattun hanyoyin kula da lafiya (chemotherapy). , maganin da aka yi niyya, da immunotherapy, da dai sauransu) ƙalubale ne na yau da kullum a cikin maganin cututtuka masu yawa. Marasa lafiya masu irin waɗannan nau'ikan ƙari suna da buƙatun likita na gaggawa waɗanda ba a biya su ba. Shaida ta hauhawa tana goyan bayan yuwuwar fa'idodin ƙwayoyin rigakafi na bispecific azaman tsari mai ban sha'awa don kula da ciwace-ciwacen daji. ATG-101 labari ne na PD-L1/4-1BB bispecific antibody. An ƙera shi don haɗa babban kusanci don PD-L1 da kunna sharadi na 4-1BB, wanda aka yi niyya don rage haɗarin 4-1BB mai alaƙa da hanta. Abin farin ciki ne na jagoranci gwajin PROBE-CN, nazarin asibiti na farko na ATG-101 a kasar Sin. Ƙungiyara za ta yi aiki ba tare da wata matsala ba tare da wasu masu bincike da ƙungiyar binciken Antengene. Muna fatan ATG-101 za ta ba da zaɓin magani mai inganci da aminci ga marasa lafiya da ciwace-ciwace.

Dokta Jay Mei, wanda ya kafa, Shugaba da Shugaba na Antengene, ya ce: "A cikin ɗan gajeren lokaci, ATG-101 ya ci gaba daga matakin farko na asibiti ta hanyar matakai masu ban sha'awa, ciki har da izinin IND a Australia da Amurka. , da kuma amincewar kwanan nan ta NMPA a kasar Sin don nazarin ATG-101 a cikin marasa lafiya da ci gaba da ciwace-ciwacen ƙwayar cuta da kuma B-NHL. Muna matukar farin ciki da nasarorin da shirin ya samu kuma muna fatan wannan muhimmin binciken zai taimaka wajen ci gaba da ingantaccen magani ga marasa lafiya masu fama da ciwace-ciwace da kuma NHL wadanda suka sake dawowa ko kuma suka zama masu ƙin yarda da maganin PD-1/L1.

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Avatar na Linda Hohnholz

Linda Hohnholz

Edita a shugaba don eTurboNews bisa ga eTN HQ.

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