Chav Haujlwm Thoob Ntiaj Teb

Thaum Lub Peb Hlis 21, 2025, Junshi Biosciences tshaj tawm tias Lub Chaw Saib Xyuas Khoom Siv Kho Mob Hauv Tebchaws ("NMPA") tau pom zoo rau daim ntawv thov tshuaj tshiab ntxiv ("sNDA") rau cov khoom lag luam ntawm lub tuam txhab, toripalimab, ua ke nrog bevacizumab rau kev kho mob thawj kab ntawm cov qog nqaij hlav uas tsis tuaj yeem phais lossis kis mus rau lwm qhov ...Nyeem ntxiv»

Thaum Lub Peb Hlis 21, 2025, tshaj tawm tias Daim Ntawv Thov Tshuaj Tshiab ("NDA") rau TAZVERIK® (tazemetostat) tau txais kev pom zoo hauv Suav teb rau kev kho mob rau cov neeg laus uas rov qab mob lossis tsis kho tau ("R/R") follicular lymphoma ("FL") nrog EZH2 mutation uas tau txais tsawg kawg yog ob qho ua ntej ...Nyeem ntxiv»

Thaum Lub Peb Hlis 10, 2025, Sichuan Kelun-Biotech tshaj tawm tias Lub Tuam Txhab trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, yav tas los SKB264 / MK-2870) tau pom zoo rau kev lag luam los ntawm National Medical Products Administration (NMPA...Nyeem ntxiv»

Thaum Lub Peb Hlis 18, 2025, Alphamab Oncology tshaj tawm tias anti-HER2 biparatopic antibody-drug conjugate (ADC) JSKN003 tau txais Breakthrough Therapy Designation los ntawm Center for Drug Evaluation (CDE) ntawm National Medical Products Administration (NMPA). Lub npe no yog rau kev kho mob ntawm ...Nyeem ntxiv»

Thaum Lub Peb Hlis 10, 2025, Hansoh Pharma tshaj tawm daim ntawv thov tshuaj tshiab thib peb ("NDA") ntawm pawg tshuaj tshiab Ameile (阿美乐®) (Aumolertinib Mesilate Tablets) tau txais kev pom zoo los ntawm National Medical Products Administration of China ("NMPA") rau kev kho mob rau cov neeg mob uas muaj kev kho mob hauv zos, ...Nyeem ntxiv»

Thaum Lub Peb Hlis 12, 2025, Zai Lab Limited tshaj tawm tias Tuam Tshoj Lub Chaw Saib Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) tau lees txais Daim Ntawv Thov Daim Ntawv Tso Cai Biologics (BLA) rau TIVDAK (tisotumab vedotin-tftv) rau kev kho mob rau cov neeg mob uas muaj mob qog nqaij hlav rov tshwm sim lossis kis mus rau lwm qhov nrog kev nce qib ntawm tus kab mob ...Nyeem ntxiv»

Thaum Lub Peb Hlis 5, 2025, Ascentage Pharma tshaj tawm tias nws cov tshuaj, olverembatinib, tau txais kev tso cai Breakthrough Therapy Designation (BTD) los ntawm Center for Drug Evaluation (CDE) ntawm Tuam Tshoj National Medical Products Administration (NMPA), rau kev sib xyaw nrog kev kho mob chemotherapy qis-siv zog rau thawj-...Nyeem ntxiv»

Thaum Lub Peb Hlis 4, 2025, BeiGene tshaj tawm tias US Food and Drug Administration (FDA) tau pom zoo TEVIMBRA (tislelizumab-jsgr), ua ke nrog platinum-containing chemotherapy, rau thawj kab kev kho mob rau cov neeg laus uas tsis tuaj yeem phais lossis metastatic esophageal squamous cell carcinoma (ESCC) uas ...Nyeem ntxiv»

Thaum Lub Ob Hlis 25, 2025, Tuam Tshoj Lub Chaw Tswj Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) tau pom zoo finotonlimab ua ke nrog SCT510 rau kev kho mob ntawm cov kab mob siab hepatocellular carcinoma uas tsis tuaj yeem phais lossis metastatic uas tsis tau txais kev kho mob ua ntej. Finotonlimab yog ib qho recombinant humanized IgG4 ...Nyeem ntxiv»

Thaum Lub Ob Hlis 8, 2025, Lub Chaw Haujlwm Saib Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) ntawm Tuam Tshoj tau pom zoo rau Sinocelltech Group Ltd's finotonlimab, uas yog ib qho tshuaj monoclonal antibody (mAb) uas tau tsim los siv ua ke nrog platinum-based chemotherapy ua thawj txoj kev kho mob rau cov kab mob rov tshwm sim thiab/lossis metas...Nyeem ntxiv»

Thaum Lub Ob Hlis 21, 2025, Lub Chaw Saib Xyuas Kev Tshuaj Xyuas Tshuaj (CDE) ntawm Tuam Tshoj Lub Chaw Tswj Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) tau tso cai rau Breakthrough Therapy Designation (BTD) rau Satri-cel (CT041) (tus neeg sib tw khoom CAR T-cell autologous tawm tsam Claudin18.2), rau kev mob plab hnyuv / esophagogastric siab heev ...Nyeem ntxiv»

Thaum Lub Ob Hlis 22, 2025, Daim Ntawv Thov Tshuaj Tshiab (NDA) rau kev txhaj tshuaj ipilimumab (anti-CTLA-4 monoclonal antibody; R&D Code: IBI310) tau txais los ntawm Chaw Saib Xyuas Kev Tshuaj Xyuas Tshuaj (CDE) ntawm Tuam Tshoj Lub Chaw Tswj Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) thiab tau txais kev tshuaj xyuas ua ntej hauv com ...Nyeem ntxiv»