NMPA YATANZE UMUTI WAGENWEHO UBUVUZI BW'UMUTI WA B7-H3 CONJUGATE HS-20093 URI KU BUVUZI BWA NSCLC

Ku ya 17 Mata 2025, Hansoh Pharmaceutical yatangaje ko umuti wa B7-H3-target antibody-drug conjugate (ADC) HS-20093 wikoreye itsinda ryawo wo guterwa inshinge wahawe uburenganzira bwo gushyirwa mu bwoko bwa Breakthrough-Therapy-Designed Medicine n’Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi (NMPA) mu Bushinwa, hamwe n’ikimenyetso cyatanzwe cyerekana kanseri y’ibihaha idakomeye cyangwa isanzwe itera kanseri y’ibihaha (NSCLC) idafite impinduka zikomeye, yakomeje cyangwa yongera kugaruka nyuma ya platine-based chemotherapy.

HS-20093 ni ADC y’ubushakashatsi ya B7-H3 igizwe n’umuti w’umubiri w’umuntu urwanya B7-H3 ufitanye isano n’umutwaro w’ingufu za topoisomerase (TOPOi) kandi ikaba yarakorewe kuvura kanseri y’ibihaha, sarcoma, kanseri yo mu mutwe n’ijosi n’izindi kanseri zikomeye mu magerageza menshi yo kwa muganga mu Bushinwa, aho icyiciro cyo hejuru cy’ubushakashatsi ari ikizamini cya Ⅲ cy’ubuvuzi.

Iyi nyandiko ishyigikiwe n'amakuru y'ibanze y'ubushakashatsi bwa ARTEMIS-001. Iri ni igerageza rikomeje ry’icyiciro cya mbere, rikorerwa mu byiciro byinshi, ry’abarwayi barenga 300 basuzuma umutekano, ubushobozi bwo kwihanganira indwara, n'imikorere y'ibanze yo kurwanya kanseri mu ndwara ikomeye cyangwa kanseri y’ibihaha isanzwe (kanseri y’ibihaha idasanzwe cyangwa kanseri y’uturemangingo duto idafite impinduka, yazamutse cyangwa yongeye kugaruka nyuma ya platine-based chemotherapy), ryakozwe na Hansoh Pharma.

Mbere, HS-20093 yari yarahawe uburenganzira bwo gushyirwa mu cyiciro cy’imiti yagenwe na NMPA nk’umuti wagenewe ubuvuzi bushingiye ku bipimo bibiri:

·Kanseri y'ibihaha y'uturemangingo duto (ES-SCLC) yavutse nyuma yo kuvurwa ku buryo busanzwe (chimiotherapie ya platinum doublet ivanze na immunotherapy).

·Osteosarcoma ku barwayi bamaze nibura inzira ebyiri z'ubuvuzi mbere.

Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.

Nimero ya Terefone: 4008803716

Email：myimmnet@163.com