预约演示
更新于：2026-02-05
Retlirafusp alfa
瑞拉芙普-α
更新于：2026-02-05
概要
基本信息
药物类型 抗体融合蛋白 |
别名 SHR 1701、SHR-1701、艾泽利 |
作用方式 抑制剂 |
作用机制 PDL1抑制剂(程序性死亡配体1抑制剂)、TGFBR2抑制剂(转化生长因子β受体2抑制剂) |
在研适应症 |
原研机构 |
在研机构 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 中国 (2026-01-05), |
最高研发阶段(中国)批准上市 |
特殊审评- |
登录后查看时间轴
结构/序列
Sequence Code 13388069L
来源: *****
Sequence Code 524307712H
来源: *****
关联
46
项与 瑞拉芙普-α 相关的临床试验NCT07384234
SHR-1701 Combined With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis: A Randomized, Two-Cohort Study
NCT07311408
SHR-1701 Combined With Rivoceranib, With or Without SHR-2554, in Patients With Advanced Gastric Cancer Who Have Failed First-Line Immunotherapy
NCT07355010
A Randomized, Open-label, Double-cohort Study of Fluzoparib Combined With Famitinib Malate or SHR-1701 for Neoadjuvant Therapy in Patients With Advanced Ovarian Cancer
100 项与 瑞拉芙普-α 相关的临床结果
登录后查看更多信息
100 项与 瑞拉芙普-α 相关的转化医学
登录后查看更多信息
100 项与 瑞拉芙普-α 相关的专利（医药）
登录后查看更多信息
11
项与 瑞拉芙普-α 相关的文献（医药）2026-01-01CANCER LETTERS
Efficacy and safety of SHR-1701 combined with chemoradiotherapy as neoadjuvant treatment for locally advanced rectal cancer
Article
作者: Chang, Wenju ; Xu, Jianmin ; Ding, Kefeng ; Wang, Jian ; Yu, Mengzhu ; He, Guodong ; Lv, Yang ; Jiang, Yingyi ; Tang, Wentao ; Mao, Rongfu ; Rao, Shengxiang ; Xie, Haiting ; Wei, Ye ; Huang, Chuanpei
Locally advanced rectal cancer (LARC) remains challenging to treat due to high recurrence rates and limited therapeutic options, particularly for patients with high-risk features. This prospective, multicenter, single-arm, open-label phase 2 trial (ClinicalTrials.gov identifier: NCT05300269) evaluated the efficacy and safety of SHR-1701, a novel bifunctional fusion protein targeting both PD-L1 and TGF-β, in combination with neoadjuvant chemoradiotherapy (CRT) followed by total mesorectal excision (TME) for high-risk LARC. Eligible patients had at least one high-risk factor, including cT3c-d or cT4 tumors, positive mesorectal fascia, extramural vascular invasion, or involvement of ≥4 lymph nodes. Patients received concurrent SHR-1701 and CRT, followed by two cycles of SHR-1701 plus XELOX and subsequent TME surgery. Postoperatively, patients underwent six additional cycles of SHR-1701 plus XELOX. The primary endpoints were pathological complete response (pCR) rate and safety. Among the 37 enrolled patients, 36 (97.3 %) completed the planned full-dose radiotherapy (50.4 Gy in 28 fractions) and subsequently underwent surgery. The pCR rate was 36.1 % (13/36). The median intervals from neoadjuvant therapy initiation to surgery and from surgery to adjuvant therapy were 112 days (range, 95-139) and 29 days (range, 22-59), respectively. The median follow-up was 9.9 months (range, 2-18) from the first dose of capecitabine. Grade ≥3 treatment-related adverse events during neoadjuvant therapy occurred in 40.5 % (15/37) of patients, most commonly lymphopenia (37.8 %, 14/37) and anemia (5.4 %, 2/37). One patient experienced fatal immune-mediated myocarditis prior to surgery. Overall, the addition of SHR-1701 to CRT demonstrated encouraging efficacy and manageable safety in high-risk LARC, supporting further investigation in larger randomized trials.
2024-07-01CANCER CELL
Neoadjuvant SHR-1701 with or without chemotherapy in unresectable stage III non-small-cell lung cancer: A proof-of-concept, phase 2 trial
Article
作者: Liu, Baogang ; Wang, Hui ; Chen, Qixun ; Pang, Qingsong ; Yang, Xuening ; Zhang, Zhenfa ; Li, Xiao ; Shi, Wei ; Yang, Weihua ; Wang, Qifeng ; Li, Baosheng ; Song, Li ; Wu, Yi-Long ; Du, Xianghui ; Cai, Kaican ; Huang, Yunchao ; Zhao, Yanqiu ; Pan, Yi ; Yao, Jun ; Han, Guang ; Zhou, Qing
We conducted a proof-of-concept, phase 2 trial to assess neoadjuvant SHR-1701 with or without chemotherapy, followed by surgery or radiotherapy, and then consolidation SHR-1701 in unresectable stage III non-small-cell lung cancer (NSCLC). In the primary cohort of patients receiving neoadjuvant combination therapy (n = 97), both primary endpoints were met, with a post-induction objective response rate of 58% (95% confidence interval [CI] 47-68) and an 18-month event-free survival (EFS) rate of 56.6% (95% CI 45.2-66.5). Overall, 27 (25%) patients underwent surgery; all achieved R0 resection. Among them, 12 (44%) major pathological responses and seven (26%) pathological complete responses were recorded. The 18-month EFS rate was 74.1% (95% CI 53.2-86.7) in surgical patients and 57.3% (43.0-69.3) in radiotherapy-treated patients. Neoadjuvant SHR-1701 with chemotherapy, followed by surgery or radiotherapy, showed promising efficacy with a tolerable safety profile in unresectable stage III NSCLC. Surgical conversion was feasible in a notable proportion of patients and associated with better survival outcomes.
2024-01-01International journal of biological sciences
Blocking EGR1/TGF-β1 and CD44s/STAT3 Crosstalk Inhibits Peritoneal Metastasis of Gastric Cancer
Article
作者: Yu, Beiqin ; Cai, Qu ; Zhang, Benyan ; Jin, Yangbing ; Wang, Chao ; Zhang, Zhihao ; Zhao, Liqin ; Ji, Jun ; Sun, Ying ; Zhang, Jun ; Jiang, Jinling
Peritoneal metastasis (PM) continues to limit the clinical efficacy of gastric cancer (GC). Early growth response 1 (EGR1) plays an important role in tumor cell proliferation, angiogenesis and invasion. However, the role of EGR1 derived from the tumor microenvironment in reshaping the phenotypes of GC cells and its specific molecular mechanisms in increasing the potential for PM are still unclear. In this study, we reported that EGR1 was significantly up-regulated in mesothelial cells from GC peritoneal metastases, leading to enhanced epithelial-mesenchymal transformation (EMT) and stemness phenotypes of GC cells under co-culture conditions. These phenotypes were achieved through the transcription and secretion of TGF-β1 by EGR1 in mesothelial cells, which could regulate the expression and internalization of CD44s. After being internalized into the cytoplasm, CD44s interacted with STAT3 to promote STAT3 phosphorylation and activation, and induced EMT and stemness gene transcription, thus positively regulating the metastasis of GC cells. Moreover, TGF-β1 secretion in the PM microenvironment was significantly increased compared with the matched primary tumor. The blocking effect of SHR-1701 on TGF-β1 was verified by inhibiting peritoneal metastases in xenografts. Collectively, the interplay of EGR1/TGF-β1/CD44s/STAT3 signaling between mesothelial cells and GC cells induces EMT and stemness phenotypes, offering potential as a therapeutic target for PM of GC.
556
项与 瑞拉芙普-α 相关的新闻（医药）2026-02-04
·药时代
引进/卖出临床1期siRNA临床申请
2026-02-03
上市批准临床3期申请上市
2026-02-03
·药时代
并购引进/卖出siRNA高管变更
100 项与 瑞拉芙普-α 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| PD-L1阳性胃食管交界处腺癌 | 中国 | 2026-01-05 | |
| PD-L1阳性胃癌 | 中国 | 2026-01-05 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 子宫颈转移癌 | 临床3期 | 中国 | 2022-02-26 | |
| 局部晚期胃癌 | 临床3期 | 中国 | 2022-01-26 | |
| 非鳞状非小细胞肺癌 | 临床3期 | 中国 | 2022-01-24 | |
| 转移性非鳞状非小细胞肺癌 | 临床3期 | - | 2021-12-30 | |
| 胃食管交界处恶性肿瘤 | 临床3期 | 中国 | 2021-12-06 | |
| 转移性胃食管结合部腺癌 | 临床3期 | 中国 | 2021-12-06 | |
| 胃食管交界处癌 | 临床3期 | 中国 | 2021-12-01 | |
| 转移性结直肠癌 | 临床3期 | 中国 | 2021-06-22 | |
| 晚期宫颈癌 | 临床3期 | - | - | |
| 晚期胃癌 | 临床3期 | - | - |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 660 | SHR-1701 plus CAPOX | 衊構蓋獵憲艱夢構醖窪(淵糧廠壓齋製襯糧繭膚) = 餘齋築夢範壓醖網鹽夢 觸淵餘範選簾鬱鏇顧淵 (願鹹齋願廠淵蓋衊簾鏇, 14.4 ~ 18.5) 更多 | 积极 | 2025-12-05 | ||
Placebo plus CAPOX | 衊構蓋獵憲艱夢構醖窪(淵糧廠壓齋製襯糧繭膚) = 廠選鹹築窪築繭築選網 觸淵餘範選簾鬱鏇顧淵 (願鹹齋願廠淵蓋衊簾鏇, 9.3 ~ 12.1) 更多 | ||||||
临床3期 | 720 | SHR-1701 plus CAPOX | 遞範製鏇鏇積構衊膚糧(襯鹹糧餘夢衊選鏇繭蓋) = 鏇鏇積齋鏇願選窪簾鏇 鬱簾鹽壓鹽製鹹蓋壓憲 (憲獵齋窪壓顧鹹淵膚遞 ) 更多 | 积极 | 2025-10-17 | ||
placebo plus CAPOX | - | ||||||
临床2期 | 局部晚期直肠癌 新辅助 | 37 | SHR-1701 + XELOX + Concurrent CRT | 鹽願夢製願範艱簾憲淵(糧範壓鬱醖範簾獵艱願) = 繭鏇廠鑰蓋網衊艱網製 糧願糧顧製廠繭鹽襯鬱 (獵壓顧膚醖範鏇憲鑰範 ) 更多 | 积极 | 2025-08-01 | |
临床2期 | 12 | 廠網衊淵衊獵壓淵膚築(淵鹹願憲築築願壓壓夢) = 壓積鬱選顧艱觸願齋構 構觸遞積鬱範簾網願衊 (夢醖鬱淵淵蓋製蓋選範, 13.81% ~ 60.93) 更多 | 积极 | 2025-05-30 | |||
临床3期 | 730 | SHR-1701 + CAPOX | 選鹹蓋鑰膚願壓醖範壓(網糧襯衊淵壓築積鏇壓) = 憲淵製窪鏇簾鏇觸鑰窪 鹽構廠壓襯夢醖獵齋鹹 (蓋夢襯憲憲範窪願鬱鏇 ) 更多 | 积极 | 2025-01-23 | ||
Placebo + CAPOX | 選鹹蓋鑰膚願壓醖範壓(網糧襯衊淵壓築積鏇壓) = 齋齋糧遞齋糧觸觸積鏇 鹽構廠壓襯夢醖獵齋鹹 (蓋夢襯憲憲範窪願鬱鏇 ) 更多 | ||||||
临床2/3期 | 转移性结直肠癌 一线 | 62 | 鬱網網鹹夢鬱鏇鹹窪遞(顧窪蓋襯築廠醖艱築簾) = 餘積衊艱築憲夢壓窪顧 鑰糧憲觸願憲鬱鹹觸艱 (顧鏇襯夢齋積壓蓋憲鹽 ) 更多 | 积极 | 2024-12-20 | ||
临床2期 | 51 | 網築襯範鹹夢觸膚構壓(鹹鏇齋鹹製餘襯鹽鹽艱) = 簾網壓衊鹽顧壓蓋鏇衊 壓顧襯淵構範遞鏇觸艱 (餘繭願鹹窪膚憲衊顧蓋, 12.1 ~ 49.4) 更多 | 积极 | 2024-12-13 | |||
網築襯範鹹夢觸膚構壓(鹹鏇齋鹹製餘襯鹽鹽艱) = 繭簾遞選範願齋衊窪襯 壓顧襯淵構範遞鏇觸艱 (餘繭願鹹窪膚憲衊顧蓋, 3.2 ~ 37.9) 更多 | |||||||
临床1/2期 | 胰腺癌 一线 | 56 | 鹹蓋鬱簾醖觸積遞壓繭(繭鑰築蓋顧網窪齋蓋鬱) = 積顧鹹鹽淵鬱範淵網鑰 夢鹽製顧鏇廠餘顧鹽醖 (選憲網顧鏇顧願鹽齋齋, 20.3 ~ 46.0) 更多 | 积极 | 2024-09-16 | ||
(PD-L1 TPS≥1%) | 鹹蓋鬱簾醖觸積遞壓繭(繭鑰築蓋顧網窪齋蓋鬱) = 觸積積餘艱鹽糧範膚淵 夢鹽製顧鏇廠餘顧鹽醖 (選憲網顧鏇顧願鹽齋齋 ) 更多 | ||||||
临床3期 | 731 | SHR-1701+Chemo (ITT) | 夢簾窪網鹽艱蓋願鏇窪(鏇網獵構獵選築衊觸積) = 築壓構壓窪鏇選簾淵淵 積簾顧築繭齋襯築築製 (簾獵衊壓遞齋觸憲淵糧, 14.0 ~ 16.9) 更多 | 积极 | 2024-09-16 | ||
Placebo+Chemo (ITT) | 夢簾窪網鹽艱蓋願鏇窪(鏇網獵構獵選築衊觸積) = 廠鹽鹽鹹艱遞壓鏇願顧 積簾顧築繭齋襯築築製 (簾獵衊壓遞齋觸憲淵糧, 9.4 ~ 12.1) 更多 | ||||||
临床2期 | 晚期鳞状细胞肺癌 一线 | 维持 | 23 | 壓齋構憲夢選構憲築廠(築醖窪鑰夢窪築襯艱醖) = 範壓壓壓製簾繭齋壓積 廠鹽醖夢壓獵廠壓艱鑰 (構顧醖築網憲觸廠鹽鬱 ) 更多 | 积极 | 2024-09-10 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
生物类似药
生物类似药在不同国家/地区的竞争态势。请注意临床1/2期并入临床2期，临床2/3期并入临床3期
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用