YL201

Phase 3Small molecule

MMediLink Therapeutics (Suzhou) Co., Ltd.

YL201 is one of 245 small molecule programs targeting Advanced Solid Tumor. It is currently in Phase 3.

Indications

Total Trials

Active Trials

244

Competitors

Pipeline

Status by Indication[3][1]

Indication

Advanced Solid TumorRecruiting

Advanced Esophageal Squamous Cell CarcinomaRecruiting

EfficacyRecruiting

Nasopharyngeal CarcinomaRecruiting

Small Cell Lung CancerRecruiting

Advanced Solid TumorsRecruiting

SCLC, Extensive StageRecruiting

Patients With Advanced Solid TumorsNot yet recruiting

Selected Advanced Solid TumorsActive, not recruiting

Advanced Solid TumorPreclinical

Recruiting

Advanced Esophageal Squamous Cell CarcinomaPhase 3

Recruiting

EfficacyPhase 2

Recruiting

Nasopharyngeal CarcinomaPhase 3

Recruiting

Small Cell Lung CancerPhase 3

Recruiting

Advanced Solid TumorsPhase 2

Recruiting

SCLC, Extensive StagePhase 3

Recruiting

Patients With Advanced Solid TumorsPreclinical

Not yet recruiting

Selected Advanced Solid TumorsPhase 2

Active, not recruiting

Competition

Competitive Landscape

311 competitors in Advanced Solid Tumors

#DrugCompanyPhaseTrials

Taxol

Teva

Phase 2

25 2

Opdivo

Bristol-Myers Squibb

Phase 2

19 3

Fludara

Sanofi

Phase 2

16 4

Avastin

Roche

Phase 2

15 5

Paraplatin

AAvyxa

Phase 2

32 6

Beyfortus

BeiGene

Phase 2

10 7

Imfinzi

AstraZeneca

Phase 2

10 8

Cytoxan

BBaxter Healthcare Corporation

Phase 2

19 9

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Braftovi

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

Timeline

Expected Milestones

Q4 2027

PreclinicalRecruiting

Advanced Solid Tumor

NCT05434234

Phase 1/2Recruiting

Advanced Solid Tumors

NCT07208773

Q2 2028

Phase 1/2Recruiting

Nasopharyngeal Carcinoma

NCT07258979

Q4 2028

Phase 1/2Active, not recruiting

Selected Advanced Solid Tumors

NCT06057922

Phase 3Active, not recruiting

Nasopharyngeal Carcinoma

NCT06629597

Phase 3Recruiting

Advanced Esophageal Squamous Cell Carcinoma

NCT07487896

Clinical

Trials by Indication[1]

Nasopharyngeal Carcinoma2 trials

A Study of YL201 in Combination With Toripalimab and With or Without Cisplatin in Nasopharyngeal Carcinoma.

Recruiting·MMediLink Therapeutics (Suzhou) Co., Ltd.·Phase 1/2·NCT07258979·202 enrolled

A Randomized, Controlled, Multicenter Phase III Clinical Study of YL201 Versus Investigator's Choice of Chemotherapy in Subjects With Recurrent or Metastatic Nasopharyngeal Carcinoma Who Have Failed Prior PD-(L)1 Inhibitor and at Least Two Lines of Chemotherapy

Active, not recruiting·MMediLink Therapeutics (Suzhou) Co., Ltd.·Phase 3·NCT06629597·400 enrolled

Small Cell Lung Cancer2 trials

Study of Tarlatamab in Combination With YL201 With or Without Anti-programmed Death Ligand 1 (PD-L1) in Participants With Extensive Stage (ES) Small Cell Lung Cancer (SCLC)

Recruiting· Amgen logo

Amgen·Phase 1·NCT06898957·200 enrolled

A Multicenter, Randomized, Controlled, Open-label, Phase III Study to Compare the Efficacy and Safety of YL201 Versus Topotecan Hydrochloride in Subjects With Relapsed Small Cell Lung Cancer

Active, not recruiting·MMediLink Therapeutics (Suzhou) Co., Ltd.·Phase 3·NCT06612151·438 enrolled

Advanced Solid Tumors2 trials

A Study of YL201 and Ivonescimab (AK112) in Advanced Solid Tumors

Recruiting·MMediLink Therapeutics (Suzhou) Co., Ltd.·Phase 1/2·NCT07208773·260 enrolled

A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Combination With Serplulimab With or Without Platinum-based Chemotherapy in Selected Subjects With Advanced Solid Tumors

Active, not recruiting·MMediLink Therapeutics (Suzhou) Co., Ltd.·Phase 1·NCT06394414·187 enrolled

Selected Advanced Solid Tumors1 trial

A Study YL201 in Patients With Selected Advanced Solid Tumors

Active, not recruiting·MMediLink Therapeutics (Suzhou) Co., Ltd.·Phase 1/2·NCT06057922·990 enrolled

Efficacy1 trial

A Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With mCRPC

Recruiting·MMediLink Therapeutics (Suzhou) Co., Ltd.·Phase 2·NCT06241846·100 enrolled

4 more indications

Thoracic Neoplasms, Lung Diseases, Small Cell Lung Carcinoma1 trial

A Phase Ib/II, Multicenter, Open-Label Study to Evaluate Safety, Efficacy, and Pharmacokinetics of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors

Recruiting·MMediLink Therapeutics (Suzhou) Co., Ltd.·Preclinical·NCT07407933·118 enrolled

SCLC, Extensive Stage1 trial

A Phase III, Multicenter, Randomized, Controlled, Open-label Clinical Study to Evaluate the Efficacy and Safety of YL201 in Combination With Serplulimab Versus Carboplatin and Etoposide in Combination With Serplulimab as First-line Treatment in Participants With Treatment-naïve Extensive-stage Small Cell Lung Cancer

Recruiting·MMediLink Therapeutics (Suzhou) Co., Ltd.·Phase 3·NCT07739758·442 enrolled

Advanced Esophageal Squamous Cell Carcinoma1 trial

A Randomized, Controlled, Multicenter Phase III Study of YL201 Versus Investigator's Choice of Chemotherapy in Participants With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Failure of First-Line Therapy (TAISHAN-303)

Recruiting·MMediLink Therapeutics (Suzhou) Co., Ltd.·Phase 3·NCT07487896·440 enrolled

Advanced Solid Tumor1 trial

A Phase 1A/1B, Multicenter, Nonrandomized, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL201 as a Single Agent and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors

Recruiting·MMediLink Therapeutics (Suzhou) Co., Ltd.·Preclinical·NCT05434234·312 enrolled

Sources

References

[1]
ClinicalTrials.gov — 12 trial records for YL201. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — YL201 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for YL201. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — MediLink Therapeutics (Suzhou) 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: MMediLink Therapeutics (Suzhou) Co., Ltd.

YL201

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q2 2028

Q4 2028

Trials by Indication[1]

Nasopharyngeal Carcinoma2 trials

Small Cell Lung Cancer2 trials

Advanced Solid Tumors2 trials

Selected Advanced Solid Tumors1 trial

Efficacy1 trial

Thoracic Neoplasms, Lung Diseases, Small Cell Lung Carcinoma1 trial

SCLC, Extensive Stage1 trial

Advanced Esophageal Squamous Cell Carcinoma1 trial

Advanced Solid Tumor1 trial

References

Drug Info

Quick Facts

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