Ma Ianuali 8, 2025, ua hāʻawi ʻia ʻo 9MW2821 i ka Breakthrough Therapy Designation (BTD) e ke Center for Drug Evaluation (CDE) o ka National Medical Products Administration (NMPA) ma Kina. Hāʻawi ʻia ʻo 9MW2821 me ka toripalimab, kahi antibody monoclonal anti-PD-1, no ka carcinoma urothelial (la/mUC) i hoʻomaka mua ʻole i ka mālama ʻana, hiki ʻole ke hoʻopau ʻia, holomua kūloko a i ʻole metastatic.
Ma kahi o 9MW2821
ʻO 9MW2821 ka Nectin-4-targeting ADC mua i hoʻohui ʻia i kahi kikoʻī i hoʻomohala ʻia e Mabwell me ka hoʻohana ʻana i ka paepae ADC a me ka paepae ʻike molecular hybridoma antibody kiʻekiʻe automated, a ʻo ia ka moho lāʻau lapaʻau mua e komo i ke aʻo lapaʻau ma waena o nā ADC Nectin-4-targeting i hoʻomohala ʻia e nā ʻoihana Kina, a ʻo ka moho lāʻau lapaʻau therapeutic mua e kuhikuhi ana iā Nectin-4 ma ka honua e hōʻike i ka ʻikepili pono lapaʻau o ka maʻi ʻaʻai cervical, ka maʻi ʻaʻai esophageal a me ka maʻi ʻaʻai umauma. Ua hāʻawi ʻia ʻo 9MW2821 i ka Fast Track Designation (FTD) no ka mālama ʻana i ka carcinoma cell squamous esophageal holomua, recurrent, a i ʻole metastatic i Pepeluali 2024, a ua hāʻawi pū ʻia ʻo Orphan Drug Designation (ODD) a me FTD no ka mālama ʻana i ka maʻi ʻaʻai esophageal a me ka maʻi ʻaʻai cervical recurrent a metastatic paha i holomua ma luna a ma hope paha o ka mālama mua ʻana me kahi regimen chemotherapy platinum-based i Mei 2024.
Ua hōʻike ʻia nā hopena o kahi noiʻi lapaʻau pae I/II e hoʻohana ana i ka 9MW2821 no nā ʻōpū paʻa holomua he nui i ka 2024 American Society of Clinical Oncology Annual Meeting (ASCO).
Ma ka lā 1 o ʻApelila, 2024, ma waena o 240 mau maʻi i ka hui mahele lāʻau 1.25 mg/kg i ka hoʻokolohua lapaʻau Phase II:
ʻO ke kanesa Urothelial (UC)
No nā maʻi 37 i hiki ke loiloi ʻia no ka loiloi pono, ʻo ka helu pane pahuhopu (ORR) a me ka helu kaohi maʻi (DCR) he 62.2% a me 91.9%, kēlā me kēia, me ka median progression-free survival (mPFS) he 8.8 mahina a ʻo ka median overall survival (mOS) he 14.2 mahina.
Ka maʻi ʻaʻai o ka ʻōpū (CC)
No nā maʻi he 53 i loiloi ʻia no ka loiloi pono, ua mālama mua ʻia he 51% me ka chemotherapy doublet platinum-based a me bevacizumab, a ua loaʻa iā 58% ka chemotherapy doublet platinum-based a me ka mea hoʻopaʻa checkpoint immune, me ORR a me DCR he 35.8% a me 81.1%, kēlā me kēia. ʻO ka mPFS he 3.9 mahina, me ka hiki ʻole o ka mOS. No nā maʻi me ka ikaika o ka hoʻoluʻu ʻana o nā cell tumor Nectin-4 3+, ʻo ka ORR he 43.6% i waena o nā maʻi he 39 i loiloi ʻia.
Ka maʻi ʻaʻai ʻōpū (EC)
No nā maʻi 39 i loiloi ʻia no ka loiloi pono, ʻo ORR a me DCR he 23.1% a me 69.2%, kēlā me kēia, me mPFS o 3.9 mau mahina a me mOS o 8.2 mau mahina; 37 o lākou i mālama ʻia me ka chemotherapy platinum-based a me ka immunotherapy ma mua.
Ka maʻi ʻaʻai umauma ʻekolu-maikaʻi ʻole (TNBC)
No nā maʻi he 20 me ka maʻi ʻaʻai umauma triple-negative kūloko a i ʻole metastatic a hiki ke loiloi ʻia no ka loiloi pono, ʻo ka ORR a me ka DCR he 50.0% a me 80.0%. ʻO ka mPFS he 5.9 mau mahina, a ʻaʻole i hiki i ka mOS, me hoʻokahi mea maʻi i loaʻa ka pane piha (CR) a ua noho ma CR no 20 mau mahina a ke hoʻomau nei ʻia ʻo CR.
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
Helu Kelepona：4008803716
Email：myimmnet@163.com
Nā Kuhikuhi
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.Mabwell - E ʻimi i ke ola, e pōmaikaʻi i ke olakino
Ka manawa hoʻouna: Ian-15-2025