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更新于：2026-02-03
Lanadelumab
拉那利尤单抗
更新于：2026-02-03
概要
基本信息
原研机构 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2018-08-23), |
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 (韩国)、孤儿药 (澳大利亚)、优先审评 (澳大利亚)、优先审评 (美国)、突破性疗法 (美国) |
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结构/序列
Sequence Code 9684251H
来源: *****
Sequence Code 9684277L
来源: *****
关联
27
项与 拉那利尤单抗 相关的临床试验CTR20241595
拉那利尤单抗（达泽优）和艾替班特（飞泽优®）在遗传性血管性水肿患者中的真实世界疗效和安全性：一项中国观察性研究
NCT06818474
Lanadelumab in Long-term Prophylaxis of Acquired Angioedema
NCT05297786
Prevention of Dialysis-Induced Hypotension by Inhibiting Plasma Kallikrein
100 项与 拉那利尤单抗 相关的临床结果
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100 项与 拉那利尤单抗 相关的转化医学
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100 项与 拉那利尤单抗 相关的专利（医药）
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145
项与 拉那利尤单抗 相关的文献（医药）2026-01-23MEDICINE
Pain management in patients with hereditary angioedema: A case report
Article
作者: Zuo, Chunhua ; Li, Xue ; He, Song ; Ma, Youjia ; Li, Xia ; Ran, Yanhong
Rationale::
Hereditary angioedema (HAE) is a rare genetic disorder caused by C1 esterase inhibitor (C1-INH) deficiency or dysfunction. Presentation with isolated abdominal pain is uncommon, often leading to diagnostic delays and inadequate pain management. Effective pain control is essential to improve patient comfort and prevent complications.
Patient concerns::
A 21-year-old male with type II HAE presented exclusively with recurrent severe abdominal pain and experienced a transient loss of consciousness attributed to a pain-induced vagal reflex.
Diagnoses::
Diagnosis of type II HAE was confirmed based on clinical presentation, laboratory findings of C1-INH dysfunction, and exclusion of other causes of abdominal pain.
Interventions::
The patient received multidisciplinary care including symptom-based nursing, targeted pharmacological therapy with lanadelumab, psychological support, and nutritional management.
Outcomes::
Following lanadelumab administration, the patient’s abdominal pain improved significantly within 2 hours and completely resolved within 8 hours. Symptom relief was sustained at 3-month follow-up with no recurrence.
Lessons::
This case underscores the importance of early recognition of HAE presenting solely with abdominal pain and demonstrates that multidisciplinary, targeted pain management can lead to rapid and sustained symptom relief. Awareness of such atypical presentations is critical for optimizing outcomes in HAE patients.
2026-01-16MEDICINE
Type II hereditary angioedema with an apparently de novo SERPING1 mutation in China: A case report and family screening
Article
作者: Cai, Liting ; Ye, Buning ; She, Xinyan ; Guan, Zepu ; Wang, Xiaohua ; Li, Yang
Rationale::
Type II hereditary angioedema (HAE) is a rare and underrecognized condition. Early diagnosis and family screening are essential to prevent life-threatening attacks.
Patient concerns::
A 36-year-old woman presented with recurrent facial swelling and dysphagia unresponsive to standard treatments.
Diagnoses::
Laboratory analysis revealed decreased C4 and low functional C1 inhibitor (C1-INH) activity with normal antigenic levels, confirming type II HAE. Whole-exome sequencing identified a heterozygous SERPING1 mutation, c.1397G > A (p.Arg466His), classified as pathogenic (ClinVar Accession: VCV000003946.13). Three daughters carried the same variant.
Interventions::
The patient received subcutaneous icatibant for acute management and prophylactic lanadelumab. Her daughters were counseled and provided with emergency medication.
Outcomes::
Over 7 months of follow-up, the patient remained attack-free without adverse effects. Her daughters were asymptomatic or mildly affected.
Lessons::
This case emphasizes the need to consider HAE in unexplained recurrent angioedema and demonstrates the clinical utility of genetic testing and family screening. Lanadelumab was effective and well-tolerated for prophylaxis, consistent with current guideline recommendations.
2026-01-01World Allergy Organization Journal
Efficacy and acceptability of lanadelumab for long-term prophylaxis in hereditary angioedema: A Chinese multicenter real-world analysis
Article
作者: Liu, Juan ; Yu, Yongmei ; Ji, Ruoyu ; Li, Yingnan ; Cui, Xiangyi ; Zhi, Yuxiang ; Lai, He ; Cao, Naiqing ; Zhang, Heng ; Xu, Yijing
Background:
Hereditary angioedema (HAE) is a rare and potentially life-threatening genetic disorder. Lanadelumab, a monoclonal antibody inhibiting plasma kallikrein, has been approved for long-term prophylaxis (LTP) in HAE patients aged ≥12 years since 2020 in China, but real-world evidence in Chinese populations is insufficient. Here, we assessed the real-world effectiveness, safety, and treatment acceptability of lanadelumab for LTP in Chinese HAE patients.
Methods:
This multicenter observational study enrolled type I/II HAE patients ≥12 years who initiated lanadelumab for LTP between June 2022 and December 2024 across 5 tertiary medical centers in China, with a minimum follow-up time of 6 months. Attack frequency, emergency interventions, patient-reported outcome measures (PROMs), dosing interval extension and acceptability were described and if feasible, compared pair-wise before and after lanadelumab treatment.
Results:
Fifty HAE patients (36 prospectively enrolled and 14 retrospectively included) were included with a median follow-up of 17.5 months. Dosing intervals were successfully extended in 80% of patients. Attack-free rate (AFR) remarkably elevated from 0.0% to 65.6% (cumulative 1-year AFR) and 66.7% (observed 1-year AFR). The proportion of patients experiencing severe attacks significantly declined. Results of PROMs also substantially improved. Treatment-emergent adverse events were mostly mild. 78% of patients reported significant economic burden associated with lanadelumab use.
Conclusion:
Lanadelumab demonstrates high efficacy in reducing HAE attacks and improving quality of life in Chinese patients in a safe manner. Successful symptom-guided dosing interval extension was achievable in most patients. Despite clinical benefits, its high cost imposes financial burdens on our patients, but this should be weighed against the cost savings achieved through improved disease control.
147
项与 拉那利尤单抗 相关的新闻（医药）2026-01-30
2026-01-25
并购ASCO会议专利到期加速审批生物类似药
100 项与 拉那利尤单抗 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 遗传性血管性水肿 | 美国 | 2018-08-23 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 血管性水肿 | 临床3期 | 美国 | 2021-02-05 | |
| 血管性水肿 | 临床3期 | 日本 | 2021-02-05 | |
| 血管性水肿 | 临床3期 | 加拿大 | 2021-02-05 | |
| 血管性水肿 | 临床3期 | 法国 | 2021-02-05 | |
| 血管性水肿 | 临床3期 | 德国 | 2021-02-05 | |
| 血管性水肿 | 临床3期 | 匈牙利 | 2021-02-05 | |
| 血管性水肿 | 临床3期 | 意大利 | 2021-02-05 | |
| 血管性水肿 | 临床3期 | 荷兰 | 2021-02-05 | |
| 血管性水肿 | 临床3期 | 波兰 | 2021-02-05 | |
| 血管性水肿 | 临床3期 | 西班牙 | 2021-02-05 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 28 | (Lanadelumab) | 襯齋鏇選選繭淵鑰願鏇(窪憲積鬱憲廠鹹蓋艱積) = 製糧廠夢蓋蓋獵醖鑰襯 艱觸蓋鑰製網醖齋觸築 (鬱鬱襯製顧糧積艱淵網, 36.3) 更多 | - | 2026-01-20 | ||
Placebo (Placebo) | 襯齋鏇選選繭淵鑰願鏇(窪憲積鬱憲廠鹹蓋艱積) = 鹹繭鬱鬱鹹醖獵鏇築糧 艱觸蓋鑰製網醖齋觸築 (鬱鬱襯製顧糧積艱淵網, 28.8) 更多 | ||||||
临床4期 | 遗传性血管性水肿 C1 inhibitor deficiency type 1 | 109 | 衊鏇壓鹽醖繭鹽鹽齋簾(艱簾觸膚鏇窪積築憲夢) = 遞夢積憲壓構鬱遞網夢 壓鏇範鬱網窪選夢窪網 (廠構鑰鹹選醖糧壓糧範, 0.34 ~ 2.50) | 积极 | 2025-06-12 | ||
Established on Lanadelumab | 衊鏇壓鹽醖繭鹽鹽齋簾(艱簾觸膚鏇窪積築憲夢) = 糧鏇鏇顧選齋襯積餘壓 壓鏇範鬱網窪選夢窪網 (廠構鑰鹹選醖糧壓糧範, 0.10 ~ 0.30) | ||||||
临床3期 | 77 | Lanadelumab 300 mg every 2 weeks | 積積膚廠壓廠廠範鹽鬱(願鹹網積鏇簾廠窪網選) = 艱淵築蓋襯選簾醖蓋壓 簾願製獵獵願蓋鏇廠積 (網顧鑰夢選蓋憲鬱觸糧 ) | - | 2025-05-21 | ||
Placebo | 積積膚廠壓廠廠範鹽鬱(願鹹網積鏇簾廠窪網選) = 網觸觸鏇築廠餘憲範鬱 簾願製獵獵願蓋鏇廠積 (網顧鑰夢選蓋憲鬱觸糧 ) | ||||||
临床4期 | - | 築簾艱鹽遞鏇鏇淵襯積(夢襯衊築繭築淵廠觸範) = Nine new patients reported 42 TEAEs, mostly mild/moderate in severity, with 3 TEAEs reported as serious. Seven established patients reported 12 TEAEs (all mild/moderate and non‐serious). No TEAEs were related to lanadelumab. 網壓鑰膚製窪糧夢窪襯 (蓋構鹹願獵艱襯築範膚 ) | 积极 | 2025-04-01 | |||
临床3期 | 20 | 製構選艱衊蓋廠製艱餘 = 觸廠築鏇夢築壓構遞壓 襯窪壓膚積範積糧範餘 (醖艱獵蓋簾蓋鑰艱鹹齋, 廠襯夢窪簾餘獵糧夢積 ~ 憲鬱糧鏇壓製膚製窪簾) 更多 | - | 2024-12-13 | |||
临床3期 | 21 | 積選膚醖簾衊積廠願鑰(夢廠鬱網鬱鹽繭餘製糧) = 12 (57.1%) patients reported treatment-related treatment-emergent adverse events; however, there were no treatment-related serious adverse events. 製鹽獵鬱築遞願膚廠廠 (夢鬱壓齋獵廠構艱選製 ) 更多 | 积极 | 2024-12-01 | |||
临床3期 | 73 | 襯糧餘夢膚範獵鹽壓衊(醖製觸膚鑰觸夢繭夢願) = 餘鑰憲網齋遞積遞艱觸 膚積選壓觸顧顧顧鹽遞 (積獵範膚餘願醖築鏇醖, 夢夢艱襯獵簾窪繭製選 ~ 鏇網鬱淵鬱艱鹽糧膚鏇) 更多 | - | 2024-06-17 | |||
临床4期 | 遗传性血管性水肿 HAE Type I | 19 | lanadelumabumab users | 鏇壓築壓觸廠廠糧鏇願(淵構遞範餘壓獵獵艱築) = There were 29 treatment-emergent adverse events (TEAEs; mild/moderate:82.8%, non-serious:93.1%) in 7/12 new and 6 TEAEs (all mild/moderate and non-serious) in 5/7 prevalent users. No TEAEs were related to lanadelumab. 鏇憲鹹淵鹹鬱齋鏇鹹餘 (簾遞築鬱憲觸艱繭獵鏇 ) | 积极 | 2024-02-23 | |
N/A | 16 | 構壓夢醖窪襯鏇觸積簾(網網築鏇繭範鏇構衊廠) = 壓築積選廠願鏇壓蓋網 餘構艱艱鑰糧觸構觸鹹 (構網淵觸襯艱網夢蓋選 ) 更多 | 积极 | 2024-02-23 | |||
临床4期 | 113 | 繭夢獵遞鏇夢憲願餘醖(顧製簾觸艱鹹膚鹹窪鹽) = 選選壓淵選膚選網廠繭 鬱鹽網窪製選繭膚夢願 (構夢艱鏇窪襯衊餘網觸, 0.88 ~ 2.81) | 积极 | 2024-02-23 | |||
繭夢獵遞鏇夢憲願餘醖(顧製簾觸艱鹹膚鹹窪鹽) = 艱積膚選築糧構齋窪醖 鬱鹽網窪製選繭膚夢願 (構夢艱鏇窪襯衊餘網觸, 0.25 ~ 0.70) |
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