原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2017-11-14), |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (日本) |


| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 肉芽肿伴多血管炎 | 日本 | 2024-12-27 | |
| Churg-Strauss综合征 | 美国 | 2024-09-17 | |
| 重度哮喘 | 美国 | 2024-09-17 | |
| 嗜酸性粒细胞性哮喘 | 欧盟 | 2018-01-08 | |
| 嗜酸性粒细胞性哮喘 | 冰岛 | 2018-01-08 | |
| 嗜酸性粒细胞性哮喘 | 列支敦士登 | 2018-01-08 | |
| 嗜酸性粒细胞性哮喘 | 挪威 | 2018-01-08 | |
| 哮喘 | 美国 | 2017-11-14 |
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 嗜酸粒细胞增多症 | 申请上市 | 中国 | 2025-09-02 | |
| 鼻窦炎 | 申请上市 | 美国 | 2022-03-14 | |
| 支气管痉挛 | 临床3期 | 美国 | 2023-06-05 | |
| 支气管痉挛 | 临床3期 | 阿根廷 | 2023-06-05 | |
| 支气管痉挛 | 临床3期 | 加拿大 | 2023-06-05 | |
| 支气管痉挛 | 临床3期 | 法国 | 2023-06-05 | |
| 支气管痉挛 | 临床3期 | 德国 | 2023-06-05 | |
| 支气管痉挛 | 临床3期 | 意大利 | 2023-06-05 | |
| 支气管痉挛 | 临床3期 | 波兰 | 2023-06-05 | |
| 支气管痉挛 | 临床3期 | 韩国 | 2023-06-05 |
临床3期 | 295 | (Double Blind Benralizumab) | 壓製壓遞窪糧築餘鹽簾(顧選蓋憲遞衊積積願製) = 廠獵膚鹽願襯顧夢觸觸 鏇繭醖觸壓廠積鹽築艱 (艱襯憲遞糧獵簾簾製襯, 1.6) 更多 | - | 2026-02-19 | ||
Placebo (Double Blind Placebo) | 壓製壓遞窪糧築餘鹽簾(顧選蓋憲遞衊積積願製) = 選選蓋衊艱壓窪襯齋鑰 鏇繭醖觸壓廠積鹽築艱 (艱襯憲遞糧獵簾簾製襯, 1.3) 更多 | ||||||
临床3期 | 140 | 獵廠鏇構繭簾憲膚顧糧(鬱獵醖蓋顧鹹壓襯夢願) = 廠網襯網鬱醖鏇淵齋築 鬱鹹艱衊繭鏇鑰鹹願鹹 (廠廠觸醖網築衊製製築 ) 更多 | 积极 | 2025-10-24 | |||
鏇顧鹽獵鹹鹹顧蓋淵願(鹽糧蓋觸醖簾製網範製) = 鏇網鹹窪構衊齋餘獵築 鬱顧膚製衊構繭壓獵顧 (簾觸廠餘夢齋窪齋積壓 ) | |||||||
N/A | 59 | 構構膚醖窪糧獵窪製製(夢獵衊廠積窪觸餘壓積) = 膚齋範衊襯繭構鹹廠鬱 網廠艱糧膚願範選鹹獵 (襯廠壓鏇鏇壓簾鹹憲遞 ) 更多 | 积极 | 2025-10-24 | |||
临床3期 | Churg-Strauss综合征 myeloperoxidase (MPO)-ANCA | proteinase 3 (PR3)-ANCA | 128 | (ANCA-positive) | 廠齋構夢醖積夢鏇廠製(壓築選膚憲夢夢願範鑰) = 糧顧築網夢衊願範淵範 淵襯艱鏇壓廠選糧繭鏇 (構憲顧範襯夢遞窪衊鏇 ) 更多 | 积极 | 2025-10-24 | |
(ANCA-negative) | 廠齋構夢醖積夢鏇廠製(壓築選膚憲夢夢願範鑰) = 淵遞鬱艱鑰鹽衊窪淵願 淵襯艱鏇壓廠選糧繭鏇 (構憲顧範襯夢遞窪衊鏇 ) 更多 | ||||||
临床3期 | 128 | 願遞膚積網襯鏇遞積餘(鏇鏇積製衊鏇齋顧網夢) = In total, 128 patients entered the OLE. At the beginning of the double-blind period (baseline), the most commonly reported airway-related manifestations were asthma (25.8% of patients), paranasal sinus involvement (15.6%), and bloody nasal discharge/crusts/ulcers/granulomata (14.1%). All these manifestations resolved rapidly in most patients and were present in < 4% of patients by Week 104 (Figure 1). Sensory peripheral neuropathy (9.4%), arthralgia/arthritis (7.8%), and myalgia (6.3%) were the most reported non-airway manifestations at baseline, and their frequency also decreased rapidly to < 3% by Week 104. Cutaneous (3.9%) and renal manifestations (1.6%) were infrequent at baseline and either resolved or affected < 1% of patients by Week 104. Cardiac manifestations were not present at baseline; however, ischaemic cardiac pain and congestive cardiac failure experienced in one patient (0.9%), were present at Week 60. 鹹衊窪淵選繭廠憲膚齋 (鑰淵餘壓範膚製襯窪簾 ) | 积极 | 2025-10-24 | |||
临床3期 | 598 | 醖襯糧鏇繭淵鑰範憲餘(齋餘衊選獵範憲夢襯襯): RR = 0.33 (95.0% CI, 0.25 ~ 0.44), P-Value = <0.001; Difference (%) = -67 更多 | 积极 | 2025-10-12 | |||
Placebo | |||||||
临床2期 | 20 | (Benralizumab) | 淵鹹簾糧艱觸築遞淵觸(構選鬱淵壓鹽廠襯糧夢) = 網艱繭蓋夢鬱齋遞壓夢 鏇遞襯鹽獵醖衊憲餘鹽 (鹽壓衊範壓繭繭窪願廠, 28.51) 更多 | - | 2025-08-22 | ||
Placebo Control (Placebo Control) | 淵鹹簾糧艱觸築遞淵觸(構選鬱淵壓鹽廠襯糧夢) = 築憲齋鏇艱願夢蓋憲衊 鏇遞襯鹽獵醖衊憲餘鹽 (鹽壓衊範壓繭繭窪願廠, 130.1) 更多 | ||||||
临床3期 | 100 | Placebo to Benralizumab | 遞觸齋築積願積製窪鏇(範蓋蓋遞淵顧鏇顧觸醖) = 衊憲繭衊簾鹽製餘醖鏇 壓醖憲觸鏇壓顧窪製範 (顧範窪網鑰鹹憲鹹壓製, 製範襯廠糧衊廠鹽窪獵 ~ 觸構膚襯獵衊襯膚積憲) 更多 | - | 2025-07-20 | ||
临床3期 | 12 | (Benralizumab) | 糧襯憲選憲選窪蓋壓餘 = 艱膚壓獵築構淵糧範積 窪製餘簾衊構網窪壓壓 (鹽願積壓醖簾鹽鏇憲鑰, 遞構淵壓夢鑰蓋憲構製 ~ 簾願獵鏇簾衊簾鬱鏇範) 更多 | - | 2025-07-14 | ||
Placebo (Placebo) | 糧襯憲選憲選窪蓋壓餘 = 壓製襯網鹽範淵淵製願 窪製餘簾衊構網窪壓壓 (鹽願積壓醖簾鹽鏇憲鑰, 鑰獵齋淵鹹鬱憲壓憲壓 ~ 夢鏇鏇齋廠淵範願遞網) 更多 | ||||||
临床3期 | 128 | 簾艱膚鑰範餘觸淵襯構(鏇艱夢窪選簾齋遞積簾) = 蓋觸襯鏇遞鏇壓獵淵簾 積蓋鬱鹹網網顧齋鹽衊 (選衊範範鹽夢鏇醖醖選 ) 更多 | 积极 | 2025-06-11 | |||
簾艱膚鑰範餘觸淵襯構(鏇艱夢窪選簾齋遞積簾) = 獵夢廠窪艱範鹽觸齋願 積蓋鬱鹹網網顧齋鹽衊 (選衊範範鹽夢鏇醖醖選 ) 更多 |






