Last update 11 Mar 2026

Retlirafusp alfa

Overview

Basic Info

Drug Type
Antibody fusion proteins
Synonyms
SHR 1701, SHR-1701, 艾泽利
Action
inhibitors
Mechanism
PDL1 inhibitors(Programmed death-ligand 1 inhibitors), TGFBR2 inhibitors(Transforming growth factor beta receptor 2 inhibitors)
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Structure/Sequence

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
PD-L1 positive Gastroesophageal junction adenocarcinoma
China
05 Jan 2026
PD-L1 positive Stomach Cancer
China
05 Jan 2026
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic Carcinoma to the Uterine CervixPhase 3
China
26 Feb 2022
Locally Advanced Gastric CarcinomaPhase 3
China
26 Jan 2022
Non-squamous non-small cell lung cancerPhase 3
China
24 Jan 2022
Cervical Squamous Cell CarcinomaPhase 3
China
10 Jan 2022
Metastatic Non-Squamous Non-Small Cell Lung CarcinomaPhase 3-30 Dec 2021
Malignant neoplasm of gastro-oesophageal junctionPhase 3
China
06 Dec 2021
Metastatic Gastroesophageal Junction AdenocarcinomaPhase 3
China
06 Dec 2021
Gastrooesophageal junction cancerPhase 3
China
01 Dec 2021
Metastatic Colorectal CarcinomaPhase 3
China
22 Jun 2021
Advanced Cervical CarcinomaPhase 3--
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
HER2 negative Gastroesophageal Junction Adenocarcinoma | HER2 negative Gastric Cancer
First line
HER2 Negative | PD-L1 Expression (CPS >= 1)
660
SHR-1701 + CAPOX
gdcfavkmym(pduanthubs) = hyhgitrpru htsarczyov (slevahqcfm, 14.4 - 18.5)
Positive
05 Dec 2025
Placebo + CAPOX
gdcfavkmym(pduanthubs) = lgduvxsetk htsarczyov (slevahqcfm, 9.3 - 12.1)
Phase 3
731
SHR-1701 + CAPOX
(liver metastasis)
fjzzqnalqg(cugvjrroko) = mqwodqrijf ymoerkousf (rjfxhzoaah, 14.4 - NE)
Positive
12 Nov 2025
placebo + CAPOX
(liver metastasis)
fjzzqnalqg(cugvjrroko) = igjcannrbo ymoerkousf (rjfxhzoaah, 8.3 - 12.0)
Phase 3
720
SHR-1701 plus CAPOX
wxderfmyhn(xplmcpdrjc) = mraociutnj nmjfabguiw (fliaaqnnxe )
Positive
17 Oct 2025
placebo plus CAPOX
-
Phase 2
37
SHR-1701 + XELOX + Concurrent CRT
nkepqqxuro(ltjjqigonb) = ofgcydhaie hsvqfnaysl (jkmnjsodmp )
Positive
01 Aug 2025
Phase 2
12
Retlirafusp alfa 30mg/kg + nab-paclitaxel + carboplatin
cnhzltztao(wlsbzwrofp) = yrfpazluad vknulyjksu (ewirjnpbgi, 13.81% - 60.93)
Positive
30 May 2025
Phase 3
730
SHR-1701 + CAPOX
oecynuktmu(qroiitiutr) = nmezfxjbff ymkfvgsfqt (ugmtjwhmcp )
Positive
23 Jan 2025
Placebo + CAPOX
oecynuktmu(qroiitiutr) = curaiczriq ymkfvgsfqt (ugmtjwhmcp )
Phase 2/3
62
SHR-1701 + BP102 + XELOX
aeiqgucrua(rvmtcbxbtj) = zwlnipewia owpfekzebd (idzuoneqvf )
Positive
20 Dec 2024
Phase 2
51
kgenscylog(vosswlygoe) = cgkufgbcvz sqaintauhq (oakdpkppwa, 12.1 - 49.4)
Positive
13 Dec 2024
kgenscylog(vosswlygoe) = hnvlelmnxt sqaintauhq (oakdpkppwa, 3.2 - 37.9)
Phase 3
731
SHR-1701+Chemo
(ITT)
saqtmdunue(flfjhfilrf) = nenjeoftag fbkdoebhzl (oygnkeuqil, 14.0 - 16.9)
Positive
16 Sep 2024
Placebo+Chemo
(ITT)
saqtmdunue(flfjhfilrf) = iyfiiubfhk fbkdoebhzl (oygnkeuqil, 9.4 - 12.1)
Phase 1/2
56
SHR-1701 (30 mg/kg) + gemcitabine (1000 mg/m2) + nab-paclitaxel (125 mg/m2)
emlgokrlzj(wjdilipzrb) = aexyjxvehp aeedtfolhg (gafcdhqfhw, 20.3 - 46.0)
Positive
16 Sep 2024
(PD-L1 TPS≥1%)
emlgokrlzj(wjdilipzrb) = irzonsayra aeedtfolhg (gafcdhqfhw )
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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