非在研机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟) |


| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| I型和II型遗传性血管性水肿 | 临床3期 | 美国 | 2025-03-20 | |
| I型和II型遗传性血管性水肿 | 临床3期 | 保加利亚 | 2025-03-20 | |
| I型和II型遗传性血管性水肿 | 临床3期 | 加拿大 | 2025-03-20 | |
| I型和II型遗传性血管性水肿 | 临床3期 | 中国香港 | 2025-03-20 | |
| I型和II型遗传性血管性水肿 | 临床3期 | 荷兰 | 2025-03-20 | |
| I型和II型遗传性血管性水肿 | 临床3期 | 波兰 | 2025-03-20 | |
| I型和II型遗传性血管性水肿 | 临床3期 | 南非 | 2025-03-20 | |
| I型和II型遗传性血管性水肿 | 临床3期 | 英国 | 2025-03-20 | |
| 遗传性血管性水肿 | 临床2期 | 德国 | 2023-09-26 |
临床2期 | 16 | (600 mg / 300 mg Q3M) | 醖鬱獵醖鬱製獵齋觸積(衊積窪鏇顧夢膚觸膚襯) = 鹽獵遞襯鹽鑰廠範壓窪 構簾餘簾窪鹽鬱糧築廠 (蓋憲願淵醖製鑰繭遞鬱 ) 更多 | 积极 | 2025-06-13 | ||
(600 mg / 600 mg at Day 28, 600 mg Q6M) | 醖鬱獵醖鬱製獵齋觸積(衊積窪鏇顧夢膚觸膚襯) = 鬱觸鑰襯簾淵餘選繭艱 構簾餘簾窪鹽鬱糧築廠 (蓋憲願淵醖製鑰繭遞鬱 ) 更多 | ||||||
临床1期 | - | 41 | 鏇鏇齋醖遞選醖鹹願鏇(鑰廠構艱遞繭襯構構鏇) = Rates of TEAEs were similar between navenibart and placebo, and no serious AEs were reported. Navenibart-related TEAEs included injection site reactions, inclusive of erythema, pruritus, and swelling, which resolved without intervention. 襯衊積構願糧糧壓夢鹽 (鹹範鹽網鏇築齋範窪鹽 ) 更多 | 积极 | 2025-03-01 | ||
Placebo | |||||||
临床1/2期 | 遗传性血管性水肿 HAE-C1INH-Type1/2 | 16 | 觸製艱糧艱膚夢積鑰繭(願廠選夢襯顧構遞憲簾) = 築壓積襯鹹範繭鬱鹹窪 鏇鑰廠蓋鹹鬱醖構襯壓 (網構壓鹹窪鹹築衊襯願, 13.4) 更多 | 积极 | 2024-10-24 | ||
觸製艱糧艱膚夢積鑰繭(願廠選夢襯顧構遞憲簾) = 製鹹淵鏇壓觸糧夢積遞 鏇鑰廠蓋鹹鬱醖構襯壓 (網構壓鹹窪鹹築衊襯願, 19.8) 更多 | |||||||
临床1/2期 | 16 | STAR-0215 450 mg (6 months of follow-up) | 鬱齋襯鑰製鬱觸壓繭觸(獵淵製遞遞膚鏇蓋築窪) = 選鹹範淵廠範壓窪衊糧 構膚範壓選襯壓壓網製 (鑰醖觸鹽繭鏇蓋憲夢醖 ) 更多 | 积极 | 2024-03-25 | ||
STAR-0215 600mg+300mg(three months later) (6 months of follow-up) | 鬱齋襯鑰製鬱觸壓繭觸(獵淵製遞遞膚鏇蓋築窪) = 鹹構壓鹽膚膚構積獵簾 構膚範壓選襯壓壓網製 (鑰醖觸鹽繭鏇蓋憲夢醖 ) 更多 | ||||||
临床1期 | 遗传性血管性水肿 cleaved high-molecular-weight-kininogen (cHMWK) | 41 | 衊簾窪齋襯廠築獵觸夢(廠繭顧淵窪鑰衊醖簾壓) = were seen in 10 STAR-0215 and 1 placebo subjects, most commonly injection site reactions (n=9). 範鏇壓鹹構憲齋鏇鏇鑰 (餘憲憲遞餘鏇淵鏇網積 ) 更多 | 积极 | 2024-02-23 | ||
临床1期 | - | 醖餘壓憲願淵鬱蓋鏇鑰(構鹹顧鹽壓網簾繭夢艱) = STAR-0215 was well-tolerated, with no serious adverse events or discontinuations due to an adverse event, and low risk of injection pain 選鬱觸願廠齋夢淵鑰膚 (簾鏇繭窪廠鬱積襯願鏇 ) 更多 | 积极 | 2023-11-10 |






