Ukugunyazwa Kwezimila Eziqinile Zesifundo Esisha kanye Ne-Non-Hodgkin Lymphoma

A BAMBA MahhalaRelease 4 | eTurboNews | eTN
Isithombe sikaLinda Hohnholz
Ibhalwe ngu Linda Hohnholz

I-Antengene Corporation Limited namuhla imemezele ukuthi i-China National Medical Products Administration (NMPA) igunyaze ucwaningo lweSigaba I se-ATG-101 (ucwaningo lwe-PROBE-CN) lokwelapha izimila eziqinile ezithuthukile/ eziqinile kanye ne-B-cell non-Hodgkin lymphoma (B -NHL).

I-ATG-101 iyinoveli ye-bispecific antibody eyenzelwe ukuvimba ukuboshwa kwe-immunosuppressive PD-1/PD-L1 futhi ikhuthaze ngokwemibandela i-4-1BB, ngaleyo ndlela isebenze ama-anti-tumor immune effect, kuyilapho iletha umsebenzi othuthukisiwe wokulwa nesimila, iphrofayili yokuphepha ethuthukisiwe. Ocwaningweni lwangaphambi komtholampilo, i-ATG-101 ibonise umsebenzi obalulekile wokulwa nesimila kumamodeli ezilwane zamathumba amelana nalawo aqhubekela phambili ekwelashweni kwe-anti-PD-1/L1. Ngaphezu kwalokho, i-ATG-101 iphinde yakhombisa iphrofayili yokuphepha enhle kakhulu ezifundweni ze-GLP toxicology.

Isibhedlela iShanghai East saseTongji University siyindawo ehamba phambili yocwaningo, oluzoqhutshwa ezikhungweni ezine kulo lonke elaseChina. Lolu cwaningo olunelebula evulekile, lweSigaba soku-I esinezindawo eziningi luklanyelwe ukuhlola ukuphepha nokubekezelelana kwe-ATG-101 elawulwa ngomthambo i-monotherapy ezigulini ezinamathumba aqinile athuthukile/e-metastatic kanye ne-B-NHL. Ucwaningo luzokwenziwa ngezingxenye ezimbili (ukwenyuka komthamo kanye nokwandiswa komthamo).

USolwazi Ye Guo, iPhini likaMqondisi we-Medical Oncology esibhedlela sase-Shanghai East sase-Tongji University, onguMqondisi wesikhungo sesibhedlela esivivinya iSigaba I, kanye nomphenyi oyinhloko walolu cwaningo, uphawule wathi: “Isifo esingazweli noma esingahambisani nemithi yokwelapha esezingeni (i-chemotherapy). , ukwelapha okuhlosiwe, kanye nokwelashwa kwamasosha omzimba, njll.) kuyinselele evamile ekwelapheni izifo eziningi ezibulalayo. Iziguli ezinalezo zinhlobo zesimila zinezidingo eziphuthumayo zezokwelapha ezingahlangatshezwana nazo. Ubufakazi obandayo busekela izinzuzo ezingaba khona zama-anti-bispecific njengendlela ethembisayo yokwelapha izimila eziyingozi. I-ATG-101 iyinoveli ye-PD-L1/4-1BB anti-bispecific antibody. Yakhelwe ukuhlanganisa ukuhlobana okuphezulu kwe-PD-L1 nokusebenza okunemibandela kwe-4-1BB, okuhloswe ukunciphisa ubungozi be-hepatoxicity ehlobene ne-4-1BB. Kuyinjabulo yami enkulu ukuhola uhlolo lwe-PROBE-CN, ucwaningo lokuqala lomtholampilo lwe-ATG-101 e-China. Ithimba lami lizosebenza ngaphandle kwezihibe nabanye abaphenyi kanye nethimba labacwaningi baka-Antengene. Sithemba ukuthi i-ATG-101 izonikeza inketho yokwelashwa ephumelelayo nephephile ezigulini ezinamathumba athuthukile. "

UDkt. Jay Mei, Umsunguli, uSihlalo kanye no-CEO we-Antengene, uthe: “Ngesikhathi esifushane kakhulu, i-ATG-101 ithuthuke kusukela esigabeni sangaphambi komtholampilo ngokusebenzisa uchungechunge lwezinyathelo ezibalulekile ezijabulisayo, okuhlanganisa ukucaciswa kwe-IND e-Australia nase-US. , kanye nokugunyazwa kwakamuva kakhulu kwe-NMPA e-China kocwaningo lwe-ATG-101 ezigulini ezinamathumba aqinile athuthukile/ama-metastatic kanye ne-B-NHL. Sijabule kakhulu ngempumelelo yalolu hlelo futhi sithemba ukuthi lolu cwaningo olubalulekile luzosiza ukuqhubekisela phambili ukwelashwa kwenoveli okusebenzayo ezigulini ezinamathumba aqinile kanye ne-NHL esezibuyele emuva noma ezingasafuni ukwelapha i-anti-PD-1/L1.”

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Isithombe sikaLinda Hohnholz

Linda Hohnholz

Umhleli omkhulu we eTurboNews ezinze eTN HQ.

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