非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2019-11-14), |
最高研发阶段(中国)批准上市 |
特殊审评突破性疗法 (美国)、加速批准 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、突破性疗法 (中国)、附条件批准 (中国)、孤儿药 (日本)、特殊审批 (中国)、快速通道 (美国) |
分子式C27H29N5O3 |
InChIKeyRNOAOAWBMHREKO-QFIPXVFZSA-N |
CAS号1691249-45-2 |
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 浆母细胞淋巴瘤 | 日本 | 2024-12-27 | |
| 滤泡性淋巴瘤 | 泰国 | 2024-02-07 | |
| 华氏巨球蛋白血症难治 | 泰国 | 2024-02-07 | |
| 复发性滤泡性淋巴瘤 | 欧盟 | 2023-11-17 | |
| 复发性滤泡性淋巴瘤 | 冰岛 | 2023-11-17 | |
| 复发性滤泡性淋巴瘤 | 列支敦士登 | 2023-11-17 | |
| 复发性滤泡性淋巴瘤 | 挪威 | 2023-11-17 | |
| 复发性边缘区淋巴瘤 | 美国 | 2023-01-19 | |
| 难治性边缘区淋巴瘤 | 巴西 | 2022-11-10 | |
| 难治性滤泡性淋巴瘤 | 英国 | 2021-12-06 | |
| 边缘区B细胞淋巴瘤 | 乌拉圭 | 2021-04-28 | |
| 巨球蛋白血症 | 加拿大 | 2021-03-30 | |
| 慢性淋巴细胞白血病 | 中国 | 2020-06-03 | |
| 小淋巴细胞淋巴瘤 | 中国 | 2020-06-02 | |
| 套细胞淋巴瘤 | 美国 | 2019-11-14 |
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 特发性膜性肾病 | 临床3期 | 美国 | 2023-04-17 | |
| 特发性膜性肾病 | 临床3期 | 中国 | 2023-04-17 | |
| 特发性膜性肾病 | 临床3期 | 阿根廷 | 2023-04-17 | |
| 特发性膜性肾病 | 临床3期 | 巴西 | 2023-04-17 | |
| 特发性膜性肾病 | 临床3期 | 加拿大 | 2023-04-17 | |
| 特发性膜性肾病 | 临床3期 | 捷克 | 2023-04-17 | |
| 特发性膜性肾病 | 临床3期 | 意大利 | 2023-04-17 | |
| 特发性膜性肾病 | 临床3期 | 波兰 | 2023-04-17 | |
| 特发性膜性肾病 | 临床3期 | 俄罗斯 | 2023-04-17 | |
| 特发性膜性肾病 | 临床3期 | 土耳其 | 2023-04-17 |
临床3期 | 90 | 範鹹淵獵積積鹹網艱衊(遞餘衊願餘夢簾鹹夢餘) = 積衊鑰繭蓋製餘鹽構鬱 衊鏇壓壓網鹽構網醖鹹 (糧範襯壓淵壓簾繭憲觸 ) 更多 | 优效 | 2026-02-13 | |||
範鹹淵獵積積鹹網艱衊(遞餘衊願餘夢簾鹹夢餘) = 鹹簾網憲淵夢夢蓋積衊 衊鏇壓壓網鹽構網醖鹹 (糧範襯壓淵壓簾繭憲觸 ) 更多 | |||||||
临床3期 | 560 | 遞觸窪築願糧構壓廠獵(網襯壓顧糧繭觸衊鬱鬱) = Patients on zanubrutinib showed reduced risk of symptom deterioration associated with earlier disease progression in comparison with ibrutinib. 獵遞醖糧窪遞鹹艱顧構 (遞顧醖襯繭遞醖鬱簾簾 ) 更多 | 积极 | 2025-12-06 | |||
临床2期 | 22 | 願顧鹽壓選鬱顧簾鹽簾(醖簾窪構簾積構築願壓) = 構願膚糧鹽襯鹹廠遞膚 襯襯築顧淵構鹽鏇範鹹 (壓餘鹽艱範選鹹蓋築獵 ) 更多 | 积极 | 2025-12-06 | |||
N/A | 26 | (treatment-naïve) | 簾壓廠壓遞鑰餘選壓膚(衊範範範鑰醖範衊壓網) = Four pts required ZANU dose reductions due to adverse events (grade 1 thrombocytopenia and postsurgical bleeding; grade 2 hypertension; and grade 2 arthralgia), with improved tolerability thereafter; all had responding disease at the time of dose reduction, which continued despite dose reduction. 窪簾餘鏇鏇網製範壓淵 (憲繭廠鏇糧夢鑰鹹襯製 ) | 积极 | 2025-12-06 | ||
(relapsed/refractory) | |||||||
临床2期 | 套细胞淋巴瘤 一线 | 23 | (Age ≥65 years) | 憲鏇築齋淵顧糧築觸餘(獵積鏇膚憲襯製憲齋窪) = No grade 3-4 AEs were observed in elderly patients. Grade 3-4 adverse events (AEs) occurred mainly in younger high-risk patients, including neutropenia (38.5%), anemia (15.4%), thrombocytopenia (23.1%), and pneumonia (23.1%), mostly related to R-BAC and all manageable. 願壓獵製鹽築窪憲廠壓 (鏇網顧醖壓範構蓋顧糧 ) | 积极 | 2025-12-06 | |
(Age <65 years with high-risk features (e.g., TP53 mutation, high Ki-67)) | |||||||
N/A | 175 | 壓觸顧襯艱壓膚齋鏇願(夢獵醖簾膚網築鹹壓築) = 97% had at least one documented AE (grade unspecified) during treatment. The most common AEs were bleeding/bruising (33%), fatigue (31%), gastrointestinal symptoms (28%), musculoskeletal pain (24%), neuropsychiatric symptoms (21%), infections (15%), and cytopenia (12%). 顧窪夢鑰膚膚簾繭衊窪 (築鑰選觸鬱襯願廠鑰鏇 ) 更多 | 积极 | 2025-12-06 | |||
临床2期 | 30 | 鬱淵遞網齋夢範憲廠鹹(觸鏇襯蓋範繭艱製膚積) = 觸鹽齋淵壓襯願願壓鏇 選獵齋願壓鏇艱夢蓋糧 (齋鏇鹹襯鹽觸醖淵衊衊 ) 更多 | 积极 | 2025-12-06 | |||
N/A | 巨球蛋白血症 MYD88L265P | CXCR4 mutations | 99 | 窪鑰願簾蓋襯餘壓觸鑰(廠構製網願鏇淵壓憲衊) = 鏇鏇構製餘蓋範鏇遞廠 遞衊築壓醖選願襯夢淵 (糧獵窪廠艱淵築鹹製鑰 ) 更多 | 积极 | 2025-12-06 | ||
临床2期 | 32 | Zanubrutinib+standard G-CHOP | 蓋醖獵選壓網壓鏇鏇艱(夢範齋淵蓋遞壓窪膚鬱) = 遞簾醖憲範夢選鬱夢糧 鏇積獵廠餘艱觸鹹顧廠 (淵齋窪鑰顧獵鑰衊鏇網, 68.3 ~ 93.1) 更多 | 积极 | 2025-12-06 | ||
临床2期 | 29 | 蓋齋鑰淵繭網淵鑰鬱範(艱構窪鏇觸衊鏇齋願範) = 醖積簾觸選範鑰膚夢鑰 窪膚遞鑰廠膚製鬱衊製 (範鹹糧齋繭選淵構艱積, 68.7 ~ 98.8) 更多 | 积极 | 2025-12-06 |





