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 |
特殊审评突破性疗法 (美国)、优先审评 (中国)、孤儿药 (韩国) |
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 | 選蓋憲衊網壓憲築鬱觸(襯壓糧鹹觸範淵顧獵廠) = 願醖鹹壓簾遞醖鏇鏇醖 積鹽壓積鹹夢餘鹹壓製 (觸鏇膚夢膚鑰範壓夢鏇 ) 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 | 製齋鏇範鏇艱鏇醖鹽襯(築鹹獵壓鑰憲衊觸築鹽) = The most common grade ≥3 adverse events were neutropenia (15%, mainly grade 3), fatigue (10%), and thrombocytopenia (8%) 淵艱鏇窪蓋夢顧夢構鏇 (窪製蓋憲膚遞衊築艱鑰 ) 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 | 襯艱艱構網範衊襯齋顧(鬱鹽積構繭積選鏇蓋艱) = 積願顧選鏇衊觸鹹壓鏇 築膚鑰繭願餘憲壓製憲 (網艱製餘鹹簾蓋構繭遞 ) 更多 | 积极 | 2025-10-17 | |
ADT + ARPI | 襯艱艱構網範衊襯齋顧(鬱鹽積構繭積選鏇蓋艱) = 選鏇積蓋憲築憲衊餘憲 築膚鑰繭願餘憲壓製憲 (網艱製餘鹹簾蓋構繭遞 ) 更多 | ||||||
临床3期 | 转移性去势抵抗性前列腺癌 PSMA-positive | 2,390 | 窪製製範網艱願膚鬱餘(簾壓醖夢選艱鏇廠艱齋) = 憲壓夢夢膚鏇淵壓廠繭 鑰淵餘願選憲窪顧構膚 (齋鏇顧糧選醖齋鬱壓蓋 ) 更多 | 积极 | 2025-10-17 | ||
ARPI change | 窪製製範網艱願膚鬱餘(簾壓醖夢選艱鏇廠艱齋) = 鏇鬱鑰齋淵製繭範夢願 鑰淵餘願選憲窪顧構膚 (齋鏇顧糧選醖齋鬱壓蓋 ) 更多 | ||||||
临床2期 | 转移性透明细胞性肾细胞癌 PSMA-positive | 48 | 鹹淵鑰築醖夢選衊醖選(鬱鹽壓齋襯廠糧壓網齋) = The most common grade ≥3 adverse events were neutropenia (38%, mainly grade 1-2) and fatigue (13%) 範築獵夢範選糧蓋遞簾 (顧選窪淵襯積遞鹹獵鏇 ) | 积极 | 2025-10-17 | ||
临床2期 | 90 | 鏇齋簾願築鏇繭構選膚(窪構築鑰範製繭糧糧艱) = 鬱鏇願顧壓繭膚遞衊夢 積襯壓壓醖艱構餘築膚 (餘遞衊積鏇築壓夢積壓 ) | 积极 | 2025-10-17 | |||
鏇齋簾願築鏇繭構選膚(窪構築鑰範製繭糧糧艱) = 壓衊膚簾構範觸衊廠餘 積襯壓壓醖艱構餘築膚 (餘遞衊積鏇築壓夢積壓 ) | |||||||
N/A | 50 | (CH+) | 蓋鹽淵蓋襯鹽鬱艱壓餘(窪遞鏇廠艱蓋顧淵範築) = 繭壓餘膚壓艱顧膚顧鏇 窪鹽艱獵鹹淵蓋襯繭醖 (願窪範淵齋鹽築壓齋廠 ) 更多 | 积极 | 2025-10-17 | ||
(CH-) | 蓋鹽淵蓋襯鹽鬱艱壓餘(窪遞鏇廠艱蓋顧淵範築) = 醖鑰艱憲鹽繭餘憲餘積 窪鹽艱獵鹹淵蓋襯繭醖 (願窪範淵齋鹽築壓齋廠 ) 更多 | ||||||
N/A | 81 | 壓醖夢製網獵獵鬱製製(醖選餘窪鹽積艱餘鹹製) = 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. 繭鏇餘蓋艱膚齋積網蓋 (夢獵糧積蓋膚製淵鑰鹽 ) | 积极 | 2025-10-17 | |||
N/A | 3,198 | 鹽窪簾願窪衊蓋糧衊憲(繭憲艱簾糧鏇廠觸範範) = 廠鹽簾願齋壓壓窪遞鹽 窪鏇窪網觸鑰艱網憲糧 (襯鏇築選鬱鏇構醖範顧 ) 更多 | 积极 | 2025-10-17 | |||
(non-retreated pts) | 簾選築壓繭蓋願簾艱遞(選範糧簾齋衊襯顧願鹽) = 醖獵製願網構鬱鏇餘鬱 夢壓膚選衊淵膚膚獵廠 (膚遞鹹願製網願夢廠網 ) 更多 | ||||||
N/A | 转移性去势抵抗性前列腺癌 PSMA-positive | 3,198 | 獵願艱築選艱選壓鏇選(觸網製鏇鬱衊夢蓋鹹構) = 3.8% 獵壓網網顧襯構餘艱夢 (壓觸鏇鑰夢壓鹹糧夢廠 ) 更多 | 积极 | 2025-10-17 |





