SYS6010

Phase 3Small molecule

CCSPC Megalith Biopharmaceutical Co.,Ltd.

SYS6010 is one of 286 small molecule programs targeting Non-Small Cell Lung Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

285

Competitors

Pipeline

Status by Indication[3][1]

Indication

Non-Small Cell Lung CancerNot yet recruiting

Head and Neck Squamous Cell CarcinomaNot yet recruiting

Colorectal CancerActive, not recruiting

EGFR-Mutated Locally Advanced or Metastatic NSCLCRecruiting

Esophageal Squamous Cell CarcinomaNot yet recruiting

NSCLCNot yet recruiting

Breast CancerNot yet recruiting

Advanced Solid TumorsRecruiting

Locally Advanced or Metastatic NSCLCNot yet recruiting

Non-Small Cell Lung CancerPhase 3

Not yet recruiting

Head and Neck Squamous Cell CarcinomaPhase 3

Not yet recruiting

Colorectal CancerPreclinical

Active, not recruiting

EGFR-Mutated Locally Advanced or Metastatic NSCLCPhase 3

Recruiting

Esophageal Squamous Cell CarcinomaPhase 3

Not yet recruiting

NSCLCPhase 3

Not yet recruiting

Breast CancerPhase 3

Not yet recruiting

Advanced Solid TumorsPhase 2

Recruiting

Locally Advanced or Metastatic NSCLCPhase 3

Not yet recruiting

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

SYS6010

CCSPC Megalith Biopharmaceutical Co.,Ltd.

Phase 3

2 2

Voltaren

Novartis

Preclinical

1 3

Zolymbus

AbbVie

Preclinical

1 4

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 5

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 6

Tricor

JJagotec

Preclinical

1 7

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 8

Acupan

YYonsei University

Preclinical

1 9

Chantix

PPrism Pharmaceuticals

Preclinical

1 10

Vfend

PPrism Pharmaceuticals

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 2Recruiting

Head and Neck Squamous Cell Carcinoma

NCT07254585

Q1 2028

Phase 1/2Not yet recruiting

Breast Cancer

NCT06775236

Q4 2028

Phase 1/2Recruiting

Advanced Solid Tumors

NCT07241936

Phase 3Not yet recruiting

Head and Neck Squamous Cell Carcinoma

NCT07758621

Phase 1Not yet recruiting

NSCLC

NCT07692048

Q2 2029

Phase 3Not yet recruiting

Locally Advanced or Metastatic NSCLC

NCT07376382

Clinical

Trials by Indication[1]

Breast Cancer2 trials

Clinical Trial of SYS6010±SYH2051 Versus Chemotherapy in Advanced Breast Cancer and Other Solid Tumors

Not yet recruiting·CCSPC Megalith Biopharmaceutical Co.,Ltd.·Phase 1/2·NCT06775236·410 enrolled

A Phase III Study of SYS6010 Versus Chemotherapy in HER2-Negative, EGFR-Positive Recurrent or Metastatic Breast Cancer

Not yet recruiting·CCSPC Megalith Biopharmaceutical Co.,Ltd.·Phase 3·NCT07406542·400 enrolled

NSCLC2 trials

SYS6010 Versus Docetaxel for Previously Treated EGFR Wild-type NSCLC: Phase Ⅲ

Not yet recruiting·CCSPC Megalith Biopharmaceutical Co.,Ltd.·Phase 3·NCT07442565·506 enrolled

A Phase Ib Study of Tislelizumab Plus SYS6010 in Immunotherapy-Pretreated Locally Advanced or Metastatic NSCLC

Not yet recruiting·SSichuan University·Phase 1·NCT07692048·21 enrolled

Head and Neck Squamous Cell Carcinoma2 trials

SYS6010 Combined With Enlonstobart In Recurrent Or Metastatic Head And Neck Squamous Cell Carcinoma

Recruiting·CCSPC Megalith Biopharmaceutical Co.,Ltd.·Phase 2·NCT07254585·70 enrolled

A Randomized, Controlled, Open-Label, Multicenter Phase 3 Trial Evaluating the Efficacy and Safety of SYS6010 Versus Investigator's Choice of Monotherapy in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Not yet recruiting·CCSPC Megalith Biopharmaceutical Co.,Ltd.·Phase 3·NCT07758621·340 enrolled

Non-Small Cell Lung Cancer2 trials

A Study of SYS6010 Combined With Osimertinib Versus Osimertinib Alone as Neoadjuvant Therapy for Patients With EGFR Mutation-positive Resectable Non-squamous Non-small Cell Lung Cancer

Not yet recruiting·CCSPC Megalith Biopharmaceutical Co.,Ltd.·Phase 2·NCT07256509·120 enrolled

A Phase III, Randomized, Open-Label Study of SYS6010 in Combination With Anti-PD-(L)-1 Monoclonal Antibody Versus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy for Patients With Completely Resected Stage II-IIIB NSCLC Who Have No Actionable Genomic Alterations and Not Achieved a Major Pathological Response.

Not yet recruiting·CCSPC Megalith Biopharmaceutical Co.,Ltd.·Phase 3·NCT07672223·570 enrolled

Colorectal Cancer1 trial

A Study of SYS6010 in Combination With SYH2051 in Patients With Advanced Colorectal Cancer and Other Gastrointestinal Tumors

Active, not recruiting·FFujian Cancer Hospital·N/A·NCT07104877·25 enrolled

4 more indications

Advanced Solid Tumors1 trial

A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid Tumors

Recruiting· CSPC ZhongQi Pharmaceutical Technology Co., Ltd. logo

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·Phase 1/2·NCT07241936·444 enrolled

Locally Advanced or Metastatic NSCLC1 trial

A Phase Ⅲ Clinical Study of SYS6010 in Combination With Osimertinib in Patients With Locally Advanced or Metastatic NSCLC

Not yet recruiting·CCSPC Megalith Biopharmaceutical Co.,Ltd.·Phase 3·NCT07376382·450 enrolled

Esophageal Squamous Cell Carcinoma1 trial

SYS6010 Versus Chemotherapy in Locally Advanced or Metastatic/Recurrent Esophageal Squamous Cell Carcinoma

Not yet recruiting·CCSPC Megalith Biopharmaceutical Co.,Ltd.·Phase 3·NCT07417735·436 enrolled

EGFR-mutated Locally Advanced or Metastatic NSCLC1 trial

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

Recruiting·CCSPC Megalith Biopharmaceutical Co.,Ltd.·Phase 3·NCT06927986·380 enrolled

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for SYS6010. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — SYS6010 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for SYS6010. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — CSPC Megalith Biopharmaceutical Co.,Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: CCSPC Megalith Biopharmaceutical Co.,Ltd.

SYS6010

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q1 2028

Q4 2028

Q2 2029

Trials by Indication[1]

Breast Cancer2 trials

NSCLC2 trials

Head and Neck Squamous Cell Carcinoma2 trials

Non-Small Cell Lung Cancer2 trials

Colorectal Cancer1 trial

Advanced Solid Tumors1 trial

Locally Advanced or Metastatic NSCLC1 trial

Esophageal Squamous Cell Carcinoma1 trial

EGFR-mutated Locally Advanced or Metastatic NSCLC1 trial

References

Drug Info

Quick Facts

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