NMPA TA BA DA MAGANIN DA AKA ƙera don maganin B7-H3 mai hana ƙwayoyin cuta da maganin HS-20093 ga nsNSCLC

A ranar 17 ga Afrilu, 2025, Hansoh Pharmaceutical ta sanar da cewa maganin rigakafi na B7-H3 da aka haɓaka da kansa don allurar rigakafi (ADC) HS-20093 na ƙungiyar ya sami amincewar a haɗa shi a matsayin maganin da aka tsara don magance cutar ta hanyar Hukumar Kayayyakin Lafiya ta Ƙasa (NMPA) ta China, tare da shawarar da aka bayar na nuna alamun cutar kansa ta huhu (NSCLC) da ta bulla a cikin gida ko kuma ta bazu ko kuma ta bazu bayan maganin chemotherapy na platinum.

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HS-20093 wani ADC ne na bincike wanda aka yi niyya ga B7-H3 wanda ya ƙunshi cikakken maganin rigakafi na ɗan adam wanda ke da alaƙa da topoisomerase inhibitor (TOPOi) kuma ana haɓaka shi don maganin ciwon daji na huhu, sarcoma, kansar kai da wuya da sauran ƙari mai ƙarfi a gwaje-gwajen asibiti da yawa a China, tare da matakin bincike mafi girma shine gwaje-gwajen asibiti na Mataki na Ⅲ.

An tallafa wa wannan tsari ta hanyar bayanan asibiti na farko daga binciken ARTEMIS-001. Wannan gwaji ne na mataki na I wanda aka gudanar a wurare da dama, wanda aka gudanar a wurare da dama, wanda aka yi wa marasa lafiya sama da 300, wanda ke kimanta aminci, juriya, da kuma aikin rigakafin ƙari na farko a cikin ciwon daji na gida ko na metastatic (ci gaba a cikin gida ko na metastatic non-squamous non-squamous non-squamous non-squamous non-squamous non-squamous non-squamous non-squamous without driver modifications, ci gaba ko sake dawowa bayan maganin chemotherapy na tushen platinum), wanda Hansoh Pharma ya gudanar.

 

A baya, HS-20093 ta sami amincewar NMPA ta haɗa ta a matsayin Magani Mai Sauƙi da aka keɓe don Kulawa saboda alamomi guda biyu:

· Ciwon daji na huhu mai matakai mai zurfi (ES-SCLC) wanda aka haɓaka bayan maganin farko na yau da kullun (maganin chemotherapy na platinum doublet tare da maganin rigakafi).

· Ciwon ƙashi (osteosarcoma) a cikin marasa lafiya waɗanda suka ci gaba da samun aƙalla hanyoyi biyu na magani a baya.

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.

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Lokacin Saƙo: Afrilu-22-2025