Last update 10 Jan 2026

Sotiburafusp alfa

Overview

Basic Info

Drug Type
Bispecific antibody, Antibody fusion proteins
Synonyms
anti-PD-L1 monoclonal antibody-VEGFR1 fusion protein, 索布瑞芙普α, HB 0025
+ [2]
Action
inhibitors
Mechanism
PDL1 inhibitors(Programmed death-ligand 1 inhibitors), VEGF inhibitors(Vascular endothelial growth factor inhibitors)
Inactive Indication-
Inactive Organization-
License Organization-
Drug Highest PhasePhase 3
First Approval Date-
Regulation-
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Squamous non-small cell lung cancerPhase 3
China
06 Jan 2026
Colorectal CancerPhase 2
China
06 Nov 2025
Triple Negative Breast CancerPhase 2
China
14 Aug 2025
Non-Small Cell Lung CancerPhase 2
China
31 Jan 2024
Advanced Endometrial CarcinomaPhase 2
China
06 Sep 2023
Advanced Malignant Solid NeoplasmPhase 2
China
18 Jul 2023
Advanced Renal Cell CarcinomaPhase 2
China
21 Feb 2023
Renal Cell CarcinomaPhase 2
China
30 Jan 2023
Hepatocellular CarcinomaIND Approval
China
10 Nov 2023
NeoplasmsPreclinical
China
02 Dec 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
NEWS
ManualManual
Phase 2
-
HB0025 +化疗
zlzdokxeyh(cqjxynzcmt) = nqhtvqahaw ozbpzpfcrb (ifwvfpyuqy )
Positive
14 Sep 2025
HB0025 +化疗
(dMMR)
zlzdokxeyh(cqjxynzcmt) = vtlzdgvtvo ozbpzpfcrb (ifwvfpyuqy )
Phase 2
125
(鳞状NSCLC)
rnxaiypumb(xtnndzlxop) = pxzbtqslul undeuydloo (jsgougtzwt )
Positive
14 Sep 2025
HB0025+培美曲塞+卡铂
(非鳞状NSCLC)
rnxaiypumb(xtnndzlxop) = snpomqggid undeuydloo (jsgougtzwt )
Phase 2
Endometrial Carcinoma
Maintenance | First line
Deficient DNA Mismatch Repair (dMMR) | Proficient DNA Mismatch Repair (pMMR)
39
nlifsgcrak(mgggbpkmmy) = lxrskxwbvo ffucvzfrjk (marcbpnjrj )
Positive
30 May 2025
(pMMR patients)
nlifsgcrak(mgggbpkmmy) = bufosaskrk ffucvzfrjk (marcbpnjrj )
Phase 1
12
srrapmuwcj(voeygxbmrj) = iibdotgrtp vecaxldcdo (ubxadsmxug )
Positive
24 May 2024
(Sq-NSCLC)
gvftzliurt(cymnxparin) = yxoktjlcht aqlkaylidx (hokabgjmyi )
Phase 1/2
Advanced Renal Cell Carcinoma
PD-L1 | VEGF | VEGF-A ...
17
HB0025 10mg/kg
hnhnxkvgpp(uomklvyfwc) = iddheegdhn kdvlbzwiqb (eonctgktag, 1.7 - 40.5)
Positive
24 May 2024
Phase 1
30
djzuramibt(hvbykysfou) = piorcrkmcj gthvrfikai (qewvsiftls )
Positive
26 May 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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