Ngomhla we-12 kweyoMdumba, ngo-2026, iZiko loVavanyo lwaMayeza (i-CDE) le-National Medical Products Administration yaseTshayina labhengeza ngomhla wesi-4 kweyoMdumba ukuba i-ENHERTU® (trastuzumab deruxtecan) icetyisiwe ukuba ifakwe kwiNkqubo yoNyango lokuPhuma ukuze isetyenziswe njengonyango oluncedisayo kwizigulane ezindala ezine-HER2-positive ekuqaleni komhlaza webele ezinesifo esisele emva konyango lwe-neoadjuvant anti-HER2. Esi sigqibo sisekelwe kwidatha enyanzelisayo evela kwisifundo se-DESTINY-Breast05 Phase III, esavezwa kwi-2025 ESMO Congress, eyabonisa ukuba i-ENHERTU inciphise umngcipheko weziganeko zokusinda ezingenazifo (IDFS) okanye ukufa nge-53% xa kuthelekiswa ne-T-DM1.
I-ENHERTU (i-trastuzumab deruxtecan; i-fam-trastuzumab deruxtecan-nxki e-US kuphela) yi-ADC eqondiswe yi-HER2. Yenzelwe kusetyenziswa iTekhnoloji ye-DXd ADC kaDaiichi Sankyo, i-ENHERTU yi-ADC ephambili kwipotifoliyo ye-oncology ye-Daiichi Sankyo kunye nenkqubo ephambili kwiqonga lesayensi le-ADC le-AstraZeneca. I-ENHERTU ine-antibody ye-HER2 monoclonal eqhotyoshelwe kwinani lee-topoisomerase I inhibitor payloads (i-exatecan derivative, DXd) nge-tetrapeptide-based cleavable linkers.
I-DESTINY-Breast05 luvavanyo lwehlabathi lonke, oluneendawo ezininzi, olucwangcisiweyo, oluvulelekileyo, oluvavanya ukusebenza kakuhle kunye nokhuseleko lwe-ENHERTU (5.4 mg/kg) xa kuthelekiswa ne-trastuzumab emtansine (T-DM1) kwizigulane ezine-HER2 positive ekuqaleni komhlaza webele kunye nesifo esisele esihlaselayo kwi-lymph nodes zebele okanye ze-axillary emva konyango lwe-neoadjuvant kunye nomngcipheko ophezulu wokubuyela umva. Umngcipheko ophezulu wokubuyela umva uchazwe njengokubonakaliswa komhlaza ongasebenziyo (ngaphambi konyango lwe-neoadjuvant) okanye i-lymph nodes ze-axillary positive emva konyango lwe-neoadjuvant.
Idatha ephambili evela kuphando lwe-DESTINY-Breast05:
- Ukusinda Okungenayo Izifo Ezihlaselayo (IDFS): Izinga le-IDFS leminyaka emithathu laliyi-92.4% kwingalo ye-ENHERTU xa kuthelekiswa ne-83.7% kwingalo yokulawula (T-DM1), nto leyo ebonisa ukuncipha komngcipheko ngama-53% (HR=0.47).
- Ukusinda Okungenazifo (i-DFS): Izinga le-DFS leminyaka emithathu laliyi-92.3% kwicala le-ENHERTU xa kuthelekiswa ne-83.5% kwicala lokulawula, nto leyo ebonisa ukunciphisa umngcipheko ngama-53% (HR=0.47).
- Umngcipheko Wokuphinda Ubuye Uvela Kude (i-DRFI): Uncitshiswe ngama-51%, kunye namazinga e-DRFI eminyaka emithathu angama-93.9% xa kuthelekiswa nama-86.1%.
- Umngcipheko we-Brain Metastasis (BMFI): Uncitshiswe ngama-36%, kunye namazinga e-BMFI eminyaka emithathu angama-97.6% xa kuthelekiswa nama-95.8%.
ISebe leMicimbi yeHlabathi leSibhedlele soMhlaza saseBeijing Southern Suburb lizinikele ekukhonzeni izigulane zaphesheya, linikezela ngenkxaso yeelwimi ezininzi, ukuhlawulisa ngqo nge-inshurensi yamazwe ngamazwe, ukuhanjiswa kwezigulane ngokwezifiso, kunye neenkonzo zokubonisana ngocingo. Kwizigulane ezinomhlaza webele we-HER2-positive, iSebe leMicimbi yeHlabathi libonelela ngeqela leengcali zomhlaza eziphezulu ezinamacandelo amaninzi ukuphuhlisa izicwangciso zonyango oluncedisayo lomntu ngamnye.
Nxibelelana ngoku ukuze ufumane uvavanyo lonyango:
Inombolo yoNxibelelwano lweZigulana zaMazwe ngaMazwe: 400-880-3716 (inkonzo yeeyure ezingama-24 ngeelwimi ezimbini, isiTshayina/isiNgesi)
Umgca othe ngqo we-WeChat: 17801183037
Official Email ①: 100085_010@163.com
Backup Email ②: myimmnet@163.com
Nokuba ungumguli osandul’ ukuxilongwa ofuna amaqhinga okufumana isifo esisele emva konyango lwe-neoadjuvant, okanye ungumguli oye wenziwa utyando kwaye ucinga ngesicwangciso sonyango olukhawulezileyo, iqela leSebe leZizwe ngezizwe linokugqiba uphononongo lwangaphambili lwerekhodi yezonyango ngokukhawuleza kwaye linike iingcebiso zonyango ezibhaliweyo.
Ixesha lokuthumela: Februwari-12-2026