Last update 16 May 2025

SYS-6010

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
CPO-301, SYS 6010, SYS-6010
+ [1]
Target
EGFR C797S x EGFR T790M x EGFR-Ex19del
Action
inhibitors
Mechanism
EGFR C797S inhibitors(Epidermal Growth Factor Receptor C797S inhibitors), EGFR T790M inhibitors(Epidermal Growth Factor Receptor T790M inhibitors), EGFR exon 19 deletion inhibitors
Therapeutic Areas
NeoplasmsRespiratory DiseasesSkin and Musculoskeletal Diseases
Active Indication
EGFR-mutated non-small Cell Lung CancerEGFR mutation Solid TumorsAdvanced breast cancer+ [8]
Inactive Indication-
Originator Organization
CSPC Megalith Biopharmaceutial Co., Ltd.
Active Organization
CSPC Megalith Biopharmaceutial Co., Ltd.Conjupro Biotherapeutics, Inc.Conjupro Biotherapeutics, Inc.CSPC Pharmaceutical Group Ltd.CSPC Pharmaceutical Group Ltd.
Inactive Organization-
License Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationFast Track (United States), Breakthrough Therapy (China)
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Structure/Sequence

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Related

14
Clinical Trials associated with SYS-6010
NCT06927986
/ Not yet recruitingPhase 3
A Randomized, Open-label, Multi-center, Phase III Clinical Study Comparing SYS6010 With Platinum-based Chemotherapy in the Treatment of EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of EGFR TKI Treatment
NCT06775236
/ Not yet recruitingPhase 1/2
A Phase 1b/2 Clinical Study to Evaluate the Safety and Efficacy of SYS6010 as a Monotherapy or in Combination With SYH2051 Compared to Investigator's Choice Chemotherapy in Patients With EGFR-Expressing Advanced Unresectable or Metastatic Solid Tumors, Including But Not Limited to Breast Cancer
CTR20244692
/ RecruitingPhase 1
评价SYS6010单药、SYS6010联合SYH2051双药在晚期实体瘤患者中安全性和有效性的Ib期临床研究
[Translation] Phase Ib clinical study to evaluate the safety and efficacy of SYS6010 alone and SYS6010 combined with SYH2051 in patients with advanced solid tumors
100 Clinical Results associated with SYS-6010
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100 Translational Medicine associated with SYS-6010
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100 Patents (Medical) associated with SYS-6010
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100 Deals associated with SYS-6010
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
EGFR-mutated non-small Cell Lung CancerPhase 3
China
CSPC Megalith Biopharmaceutial Co., Ltd.
26 Aug 2024
Advanced breast cancerPhase 2
China
CSPC Megalith Biopharmaceutial Co., Ltd.
23 Dec 2024
Advanced Lung Non-Small Cell CarcinomaPhase 2
China
CSPC Megalith Biopharmaceutial Co., Ltd.
14 Sep 2024
Advanced Malignant Solid NeoplasmPhase 2
China
CSPC Megalith Biopharmaceutial Co., Ltd.
14 Sep 2024
EGFR mutation Solid TumorsPhase 2
China
CSPC Megalith Biopharmaceutial Co., Ltd.
01 Aug 2024
EGFR Mutation Lung CancerPhase 1
China
CSPC Megalith Biopharmaceutial Co., Ltd.
24 Dec 2024
Non-Small Cell Lung CancerPhase 1
United States
Conjupro Biotherapeutics, Inc.Conjupro Biotherapeutics, Inc.
06 Jun 2023
Non-Small Cell Lung CancerPhase 1
Canada
Conjupro Biotherapeutics, Inc.Conjupro Biotherapeutics, Inc.
06 Jun 2023
Solid tumorIND Approval
Canada
CSPC Pharmaceutical Group Ltd.CSPC Pharmaceutical Group Ltd.
08 Jun 2023
EGFR C797S Mutation Non-small Cell Lung CancerIND Approval
United States
CSPC Pharmaceutical Group Ltd.CSPC Pharmaceutical Group Ltd.
02 Apr 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
CTR20231332 (AACR2025)
ManualManual
Phase 1
Advanced Malignant Solid Neoplasm | Non-squamous non-small cell lung cancer
232
smbnrnoxzs(ywyzmdcjpa) = MTD was not reached wrepizbanq (yfkcnmuvzx )
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Positive
27 Apr 2025
(≥4.8 mg/kg)
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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

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.
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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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