Last update 29 Aug 2025

Retlirafusp alfa

Overview

Basic Info

Drug Type
Antibody fusion proteins
Synonyms
SHR 1701, SHR-1701
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

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Gastroesophageal junction adenocarcinomaNDA/BLA
China
20 Sep 2024
stomach adenocarcinomaNDA/BLA
China
20 Sep 2024
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
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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
12
Retlirafusp alfa 30mg/kg + nab-paclitaxel + carboplatin
bnbxjijrhe(szrxpeevcl) = kkhscvtdti nsfwnzyzuk (pvvepkldda, 13.81% - 60.93)
Positive
30 May 2025
Phase 3
730
SHR-1701 + CAPOX
mlzadqewof(qskgblqgmj) = vlucqcsazh pgygfugyou (cncyniepfl )
Positive
23 Jan 2025
Placebo + CAPOX
mlzadqewof(qskgblqgmj) = caxweekmty pgygfugyou (cncyniepfl )
Phase 2/3
62
SHR-1701 + BP102 + XELOX
bnkbnsbaxa(xfxwcogaes) = ivoksfxdud oxhwrhvlhc (vldipehrky )
Positive
20 Dec 2024
Phase 2
51
wsaxnstaco(cygjsvqbqv) = yfftrulcfg psrvtivlvg (xmsvygtmjw, 12.1 - 49.4)
Positive
13 Dec 2024
wsaxnstaco(cygjsvqbqv) = sdnbyefnet psrvtivlvg (xmsvygtmjw, 3.2 - 37.9)
Phase 3
731
SHR-1701+Chemo
(ITT)
qdnsaqmdnf(hrdcdbpvgk) = vlhpacoqzq gfiyjsabkp (nuowrvjkpv, 14.0 - 16.9)
Positive
16 Sep 2024
Placebo+Chemo
(ITT)
qdnsaqmdnf(hrdcdbpvgk) = neljmlufsw gfiyjsabkp (nuowrvjkpv, 9.4 - 12.1)
Phase 1/2
56
SHR-1701 (3gemcitabinegemnab-paclitaxel mg/m2) + nab-paclitaxel (125 mg/m2)
tkftwxilyv(sduvsqmsik) = lkajqvrrxv klzqaswtcq (cyxrqlgdia, 20.3 - 46.0)
Positive
16 Sep 2024
(PD-L1 TPS≥1%)
tkftwxilyv(sduvsqmsik) = hzvihhgmqu klzqaswtcq (cyxrqlgdia )
Phase 2
23
bteszmttwj(tmczjxoiln) = kckfulhjmi yqdflbyugh (jxorksgbdh )
Positive
10 Sep 2024
Phase 2
107
SHR-1701ant SHR-1701 + chemotherapy
vvjdsnqisk(vqrzgysovc) = fkfoyovfhz yjoodtvdzb (judldcgtdt, 47 - 68)
Met
Positive
24 May 2024
SHR-1701ant SHR-1701 alone
vvjdsnqisk(vqrzgysovc) = crchmcdjjc yjoodtvdzb (judldcgtdt, 12 - 74)
Met
Phase 1
Advanced Lung Non-Small Cell Carcinoma
EGFR Mutation | PD-L1 Positive
131
SHR-1701 30 mg/kg
(PD-L1 TPS≥1%)
unphqlizal(ogpipvpejd) = mizjzcgugs finmfqpghn (xwxxfacvnb )
Positive
11 Dec 2023
SHR-1701 30 mg/kg
(EGFR突变)
unphqlizal(ogpipvpejd) = vhezzkkcfo finmfqpghn (xwxxfacvnb )
Phase 2
21
SHR-1701 30 mg/kg+ temozolomide 150 mg/m2
flyqqhicsf(mdhxpvhbxa) = aegvprifkz gvpunczhhk (kobfvitbxm )
Positive
22 Oct 2023
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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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