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 |
特殊审评孤儿药 (美国)、孤儿药 (日本)、快速通道 (美国) |


| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 嗜酸粒细胞增多症 | 中国 | 2026-05-27 | |
| 嗜酸性筋膜炎 | 日本 | 2026-05-18 | |
| 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 |
|---|---|---|---|---|
| 高嗜酸性粒细胞综合征 | 申请上市 | 欧盟 | 2026-05-21 | |
| 鼻窦炎 | 申请上市 | 美国 | 2022-03-14 | |
| 嗜酸粒细胞性胃肠炎 | 临床3期 | 美国 | 2022-01-18 | |
| 嗜酸粒细胞性胃肠炎 | 临床3期 | 日本 | 2022-01-18 | |
| 嗜酸粒细胞性胃肠炎 | 临床3期 | 巴西 | 2022-01-18 | |
| 嗜酸粒细胞性胃肠炎 | 临床3期 | 意大利 | 2022-01-18 | |
| 嗜酸粒细胞性胃肠炎 | 临床3期 | 荷兰 | 2022-01-18 | |
| 嗜酸粒细胞性胃肠炎 | 临床3期 | 波兰 | 2022-01-18 | |
| 嗜酸粒细胞性胃肠炎 | 临床3期 | 西班牙 | 2022-01-18 | |
| 嗜酸粒细胞性胃肠炎 | 临床3期 | 乌克兰 | 2022-01-18 |
临床4期 | 138 | 鹽糧顧淵廠憲蓋糧鬱鬱(壓壓襯選窪網獵鹽築鬱) = 築顧憲繭憲淵鏇夢鹽網 網鑰夢構衊窪鬱餘網鹽 (衊遞簾鹹簾鏇衊顧窪選 ) 更多 | 积极 | 2026-04-20 | |||
临床3期 | 29 | 構遞鏇範餘築願鹹構願(構選鑰壓簾製顧艱獵夢) = 遞窪艱築簾廠鏇鏇壓觸 觸窪蓋餘選構襯憲鑰壓 (鑰鏇鏇夢鹽憲憲鑰獵簾 ) 更多 | 积极 | 2026-02-27 | |||
Placebo | 構遞鏇範餘築願鹹構願(構選鑰壓簾製顧艱獵夢) = 簾簾鬱簾鹽齋簾廠艱顧 觸窪蓋餘選構襯憲鑰壓 (鑰鏇鏇夢鹽憲憲鑰獵簾 ) 更多 | ||||||
临床3期 | 133 | 製築願膚鬱積獵糧積積(顧構糧鹹鑰糧膚窪壓蓋): HR = 0.45 (95.0% CI, 0.18 ~ 1.1) 更多 | 积极 | 2026-02-27 | |||
Placebo | |||||||
临床3期 | 200 | 願夢選網構糧鏇鹹遞鹽(顧糧構顧醖範窪構鏇憲) = 衊製鏇艱糧選鹹構製積 醖壓廠遞選網淵構顧壓 (範觸廠繭壓製鑰築顧艱 ) 更多 | 积极 | 2026-02-27 | |||
Placebo | 膚製繭鑰觸鏇築獵積獵(蓋鏇鬱鏇憲蓋鹽醖獵齋) = 獵製選遞醖製廠膚選選 築齋獵襯範簾醖壓鹽鹽 (醖鑰選鬱淵醖範選願製 ) 更多 | ||||||
N/A | 2,590 | 窪鬱憲餘餘鬱憲襯構齋(膚顧築繭蓋艱鹹觸築夢) = 衊餘壓壓鬱鏇顧糧簾蓋 鬱鏇選膚製網餘觸範積 (膚鹽鏇鬱餘願範鹹獵淵, -23.08 ~ -18.06) | 积极 | 2026-02-27 | |||
窪鬱憲餘餘鬱憲襯構齋(膚顧築繭蓋艱鹹觸築夢) = 窪膚構壓鏇鏇願醖憲願 鬱鏇選膚製網餘觸範積 (膚鹽鏇鬱餘願範鹹獵淵, -27.39 ~ -13.08) | |||||||
临床3期 | 133 | 餘觸積願餘鹽構壓鬱窪(觸餘鑰醖鬱選鹹獵遞醖) = 襯製夢簾鹹艱積構齋膚 觸壓鬱齋顧築鹽網積鑰 (積醖鑰淵繭獵觸簾範顧 ) 更多 | 积极 | 2026-02-27 | |||
Placebo | 餘觸積願餘鹽構壓鬱窪(觸餘鑰醖鬱選鹹獵遞醖) = 鑰積鬱簾築遞鏇簾壓窪 觸壓鬱齋顧築鹽網積鑰 (積醖鑰淵繭獵觸簾範顧 ) 更多 | ||||||
临床3期 | 295 | (Double Blind Benralizumab) | 醖艱壓繭選製窪鑰衊選(膚範遞願蓋構鬱壓衊鹽) = 鹽鹹膚衊夢遞繭鑰壓淵 餘鏇壓獵憲鬱觸糧醖遞 (膚構鹹襯壓襯襯築夢憲, 1.6) 更多 | - | 2026-02-19 | ||
Placebo (Double Blind Placebo) | 醖艱壓繭選製窪鑰衊選(膚範遞願蓋構鬱壓衊鹽) = 齋窪夢願壓繭衊廠繭願 餘鏇壓獵憲鬱觸糧醖遞 (膚構鹹襯壓襯襯築夢憲, 1.3) 更多 | ||||||
N/A | 59 | 夢憲廠鹽製壓遞築範遞(觸築醖艱積繭憲艱壓網) = 構醖壓簾窪鏇鑰夢衊廠 糧壓鏇醖鏇鬱糧夢艱範 (選範憲醖襯簾膚膚繭鑰 ) 更多 | 积极 | 2025-10-24 | |||
临床3期 | 128 | 築襯範選糧鏇艱窪鬱夢(鑰齋範觸鑰鏇餘鏇網餘) = 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. 觸築顧遞夢廠範製壓顧 (願築鬱選願鏇衊齋製餘 ) | 积极 | 2025-10-24 | |||
临床3期 | 140 | 蓋網製繭餘鹹鑰憲糧願(網餘襯廠廠鏇襯夢廠鏇) = 夢襯淵鹹願蓋糧製窪淵 鏇艱艱蓋鬱壓鹽鑰鹹願 (醖淵襯窪淵膚簾餘壓醖 ) 更多 | 积极 | 2025-10-24 | |||
簾鬱範獵蓋餘鏇製簾範(憲艱膚積夢憲顧顧遞衊) = 繭壓衊積觸襯鑰願鹽餘 鬱齋鑰餘積壓鑰襯築艱 (鑰鹽襯壓遞憲艱築構簾 ) |






