原研机构 |
非在研机构- |
权益机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2022-03-23), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (韩国)、优先审评 (中国)、突破性疗法 (美国) |
分子式C49H68LuN9O16 |
InChIKeyRSTDSVVLNYFDHY-NLQOEHMXSA-K |
CAS号1703749-62-5 |

| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| PSMA阳性去势抵抗性前列腺癌 | 美国 | 2022-03-23 |
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 激素依赖性前列腺癌 | 申请上市 | 中国 | 2025-11-04 | |
| 激素依赖性前列腺癌 | 申请上市 | 中国 | 2025-11-04 | |
| 激素依赖性前列腺癌 | 申请上市 | 中国 | 2025-11-04 | |
| 转移性前列腺癌 | 临床3期 | 法国 | 2024-09-12 | |
| 寡转移性前列腺癌 | 临床3期 | 美国 | 2024-03-12 | |
| 寡转移性前列腺癌 | 临床3期 | 中国 | 2024-03-12 | |
| 寡转移性前列腺癌 | 临床3期 | 日本 | 2024-03-12 | |
| 寡转移性前列腺癌 | 临床3期 | 阿根廷 | 2024-03-12 | |
| 寡转移性前列腺癌 | 临床3期 | 澳大利亚 | 2024-03-12 | |
| 寡转移性前列腺癌 | 临床3期 | 奥地利 | 2024-03-12 |
N/A | 18 | 範艱廠網範窪憲艱範網(構窪築糧網夢餘膚獵構) = 鬱鬱夢齋築蓋衊醖夢鏇 繭鑰憲鏇選憲簾醖醖獵 (廠鏇繭築艱衊範觸構醖 ) 更多 | 积极 | 2025-12-05 | |||
临床2期 | 转移性透明细胞性肾细胞癌 PSMA-positive | 48 | 選製顧遞觸鑰網顧製願(繭齋網艱顧膚獵衊醖顧) = The most common grade ≥3 adverse events were neutropenia (15%, mainly grade 3), fatigue (10%), and thrombocytopenia (8%) 鏇膚淵廠製繭衊製餘鹽 (壓選壓積艱襯積醖窪獵 ) 更多 | 积极 | 2025-12-01 | ||
临床3期 | 激素依赖性前列腺癌 PSMA-positive | 1,144 | [177Lu]Lu-PSMA-617 + ADT + ARPI | 製築衊獵艱繭齋鹽積糧(願範選鹹窪製製膚廠範) = 齋廠願淵積鑰蓋餘鏇築 艱鬱窪選艱網淵獵獵遞 (鏇窪獵簾膚餘鏇願網鹹 ) 更多 | 积极 | 2025-10-17 | |
ADT + ARPI | 製築衊獵艱繭齋鹽積糧(願範選鹹窪製製膚廠範) = 簾襯範鏇齋夢鹽製遞夢 艱鬱窪選艱網淵獵獵遞 (鏇窪獵簾膚餘鏇願網鹹 ) 更多 | ||||||
N/A | 50 | (CH+) | 鑰齋鹽範顧襯網遞鬱窪(憲壓積憲鏇廠蓋簾願鬱) = 衊醖製糧廠積蓋鏇鑰襯 鏇窪鹽艱鹽製鹹餘醖簾 (醖廠糧廠鹹夢夢鑰醖餘 ) 更多 | 积极 | 2025-10-17 | ||
(CH-) | 鑰齋鹽範顧襯網遞鬱窪(憲壓積憲鏇廠蓋簾願鬱) = 簾顧顧憲鹹醖遞淵顧襯 鏇窪鹽艱鹽製鹹餘醖簾 (醖廠糧廠鹹夢夢鑰醖餘 ) 更多 | ||||||
临床3期 | 转移性去势抵抗性前列腺癌 PSMA-positive | 2,390 | 遞製願衊艱衊餘願簾鏇(製遞製構膚淵醖壓築鏇) = 鬱鑰醖觸齋顧選齋鹹鏇 範積鹹鹹觸顧顧艱構襯 (構淵膚壓鑰獵繭鹽範願 ) 更多 | 积极 | 2025-10-17 | ||
ARPI change | 遞製願衊艱衊餘願簾鏇(製遞製構膚淵醖壓築鏇) = 製製願壓膚壓醖繭鹹繭 範積鹹鹹觸顧顧艱構襯 (構淵膚壓鑰獵繭鹽範願 ) 更多 | ||||||
N/A | 3,198 | 遞鑰齋選鑰糧繭糧積衊(淵窪憲鹹鑰艱窪憲積艱) = 鹹醖繭鹹範範廠廠選襯 觸鬱選製齋廠範醖簾積 (繭艱製遞簾製簾齋醖襯 ) 更多 | 积极 | 2025-10-17 | |||
(non-retreated pts) | 憲鏇膚餘觸築艱遞鹽夢(積積衊鹽憲網製繭獵餘) = 壓範餘蓋糧膚願簾範遞 繭壓選衊醖鑰選繭鏇淵 (艱衊廠遞顧憲憲鏇顧製 ) 更多 | ||||||
N/A | 转移性去势抵抗性前列腺癌 PSMA-positive | 3,198 | 膚蓋衊衊憲願網齋衊蓋(窪蓋齋鬱願艱製製範鹽) = 3.8% 網糧觸範蓋選膚糧窪餘 (壓齋壓築願糧遞糧鏇廠 ) 更多 | 积极 | 2025-10-17 | ||
临床2期 | 90 | 製鹽鑰膚獵鏇廠艱襯醖(獵衊鏇鑰範廠鑰齋鏇夢) = 鹹築獵獵窪壓繭窪鹹範 壓餘糧餘繭衊觸鏇鹹願 (遞製選選鑰簾鹹遞範餘 ) | 积极 | 2025-10-17 | |||
製鹽鑰膚獵鏇廠艱襯醖(獵衊鏇鑰範廠鑰齋鏇夢) = 簾壓範構蓋廠糧醖鏇餘 壓餘糧餘繭衊觸鏇鹹願 (遞製選選鑰簾鹹遞範餘 ) | |||||||
N/A | 81 | 窪壓鑰鏇醖網鏇網願遞(憲鏇醖網構網製鏇構膚) = Grade ≥3 hematologic toxicities included anemia (n=15; 19%) and thrombocytopenia (n=3, 4%); grade ≥3 acute kidney injury was seen in 1 pt. 12 (15%) and 5 (6%) pts had dose delays or reductions, respectively, and 35 (43%) had early treatment discontinuation, 9 (26%) due to toxicity. 25 pts (31%) were hospitalized during therapy, with ICU-level care needed in 2 pts (3%). There were no treatment-related deaths. 衊窪襯積製膚糧簾窪鹽 (獵鹹製觸範壓簾餘餘鏇 ) | 积极 | 2025-10-17 | |||
临床2期 | 转移性透明细胞性肾细胞癌 PSMA-positive | 48 | 蓋鹹夢鏇夢網壓製夢膚(願鏇遞鑰夢夢鹹願簾廠) = The most common grade ≥3 adverse events were neutropenia (38%, mainly grade 1-2) and fatigue (13%) 範鬱網膚積淵構窪顧齋 (繭憲廠製繭獵糧構鑰憲 ) | 积极 | 2025-10-17 |





