SYS6010

Phase 3Small molecule

CCSPC Megalith Biopharmaceutical Co.,Ltd.

SYS6010 is one of 160 small molecule programs targeting Esophageal Squamous Cell Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

159

Competitors

Pipeline

Status by Indication[3][1]

Indication

Esophageal Squamous Cell CarcinomaActive, not recruiting

Non-Small Cell Lung CancerNot yet recruiting

Breast CancerActive, not recruiting

Colorectal CancerActive, not recruiting

Head and Neck Squamous Cell CarcinomaActive, not recruiting

NSCLCNot yet recruiting

EGFR-Mutated Locally Advanced or Metastatic NSCLCRecruiting

Esophageal Squamous Cell CarcinomaPhase 3

Active, not recruiting

Non-Small Cell Lung CancerPhase 3

Not yet recruiting

Breast CancerPhase 1/Phase 2

Active, not recruiting

Colorectal CancerPreclinical

Active, not recruiting

Head and Neck Squamous Cell CarcinomaPhase 2

Active, not recruiting

NSCLCPhase 1

Not yet recruiting

EGFR-Mutated Locally Advanced or Metastatic NSCLCPhase 3

Recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

SYS6010

CCSPC Megalith Biopharmaceutical Co.,Ltd.

Phase 3

2 2

Halaven

Eisai

Preclinical

38 3

Megace

Bristol-Myers Squibb

Preclinical

4 4

Acupan

YYonsei University

Preclinical

1 5

Chantix

PPrism Pharmaceuticals

Preclinical

1 6

Paracetamol

GSK

Preclinical

1 7

Apatinib Mesylate

BBukwang Pharmaceutical

Preclinical

3 8

Diuretic

RReprieve Cardiovascular, Inc

Preclinical

1 9

Recombinant Human Endostatin

PPeking University Third Hospital

Preclinical

1 10

Naltrexone/bupropion

Novo Nordisk

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Phase 3Recruiting

EGFR-Mutated Locally Advanced or Metastatic NSCLC

NCT06927986

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 1Not yet recruiting

NSCLC

NCT07692048

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

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

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

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

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

4 more indications

Head and Neck Squamous Cell Carcinoma1 trial

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

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

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

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 — 12 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

Q3 2026

Q4 2027

Q1 2028

Q4 2028

Trials by Indication[1]

Breast Cancer2 trials

Non-Small Cell Lung Cancer2 trials

NSCLC2 trials

Esophageal Squamous Cell Carcinoma1 trial

Locally Advanced or Metastatic NSCLC1 trial

Head and Neck Squamous Cell Carcinoma1 trial

Colorectal Cancer1 trial

Advanced Solid Tumors1 trial

EGFR-mutated Locally Advanced or Metastatic NSCLC1 trial

References

Drug Info

Quick Facts

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