Last update 14 Feb 2026

SIM0348

Overview

Basic Info

Drug Type
Bispecific antibody
Synonyms
SIM 0348, SIM-0348, SIM0348
Target
CD112R x TIGIT
Action
antagonists, inhibitors
Mechanism
CD112R antagonists(Transmembrane protein PVRIG antagonists), TIGIT inhibitors(T cell immunoglobulin and ITIM domains inhibitors)
Therapeutic Areas
Neoplasms
Active Indication
Advanced Malignant Solid NeoplasmSolid tumor
Inactive Indication-
Originator Organization
Simcere Pharmaceutical Group Ltd.Simcere Pharmaceutical Group Ltd.
Active Organization
Shanghai Xianxiang Medical Technology Co., Ltd.Jiangsu Simcere Pharmaceutical Co., Ltd.Jiangsu Simcere Pharmaceutical Co., Ltd.
Inactive Organization-
License Organization-
Drug Highest PhasePhase 1
First Approval Date-
Regulation-
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Related

1
Clinical Trials associated with SIM0348
NCT05718219
/ Active, not recruitingPhase 1
A Phase I, First-in-Human, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0348 in Subjects With Advanced Solid Tumors
100 Clinical Results associated with SIM0348
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100 Translational Medicine associated with SIM0348
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100 Patents (Medical) associated with SIM0348
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100 Deals associated with SIM0348
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced Malignant Solid NeoplasmPhase 1
China
Jiangsu Simcere Pharmaceutical Co., Ltd.Jiangsu Simcere Pharmaceutical Co., Ltd.
22 Mar 2023
Solid tumorIND Approval
China
Shanghai Xianxiang Medical Technology Co., Ltd.
12 Oct 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
NCT05718219 (ESMO_ASIA2025)
Phase 1
Advanced Malignant Solid Neoplasm
49
vtvfxqtbse(glwehrqncu) = not reached in monotherapy and combination therapy nfzjrzkcnr (emtmibgzfz )
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Positive
07 Dec 2025
SIM0348 + Sintilimab combination therapy
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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

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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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