Tafolecimab

Phase 3Monoclonal antibody

Innovent Biologics (Suzhou) Co. Ltd.

Tafolecimab is one of 182 small molecule programs targeting Colorectal Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

181

Competitors

Pipeline

Status by Indication[3][1]

Indication

Colorectal CarcinomaNot yet recruiting

Acute Coronary SyndromeActive, not recruiting

AtherosclerosisActive, not recruiting

Bladder Urothelial CarcinomaRecruiting

Non-Small Cell Lung CancerRecruiting

Acute Myocardial InfarctionNot yet recruiting

Colorectal CarcinomaPhase 3

Not yet recruiting

Acute Coronary SyndromePreclinical

Active, not recruiting

AtherosclerosisPreclinical

Active, not recruiting

Bladder Urothelial CarcinomaPhase 2

Recruiting

Non-Small Cell Lung CancerPhase 2

Recruiting

Acute Myocardial InfarctionPhase 3

Not yet recruiting

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Navelbine

PPierre Fabre Medicament

Phase 3

24 2

Pyrotinib

HHengrui Therapeutics, Inc.

Phase 3

3 3

Tafolecimab

Innovent Biologics (Suzhou) Co. Ltd.

Phase 3

1 4

TAK-788

Takeda

Phase 3

4 5

Remeron

OOrganon and Co

Preclinical

1 6

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

1 7

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—8

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—9

Vibramycin

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

Treatment

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

Timeline

Expected Milestones

Q2 2027

Phase 2Recruiting

Non-Small Cell Lung Cancer

NCT06421298

Q3 2027

Phase 2Recruiting

Extensive Stage Small Cell Lung Cancer (ES-SCLC)

NCT07061535

N/ANot yet recruiting

Atherosclerosis

NCT07341958

Q4 2027

N/ANot yet recruiting

Acute Coronary Syndrome

NCT06096909

Post-ApprovalNot yet recruiting

Acute Myocardial Infarction

NCT06683131

Q4 2028

Not yet recruiting

Hyperlipidemia

NCT07712042

Clinical

Trials by Indication[1]

Acute Coronary Syndrome1 trial

Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population

Not yet recruiting·CChina National Center for Cardiovascular Diseases·N/A·NCT06096909·3,684 enrolled

Atherosclerosis1 trial

INtensive liPid-lowering Therapy for Acute High-risk IntracRanial or Extracranial atheroSclerosis -II (INSPIRES-2)

Not yet recruiting·—·N/A·NCT07341958·242 enrolled

Non-Small Cell Lung Cancer1 trial

A Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tafolecimab and Sintilimab Combined With Chemotherapy in Patients With Advanced or Metastatic Driver Gene-negative Non-small Cell Lung Cancer After Failure of First-line Immunotherapy.

Recruiting·JJinghui Wang·Phase 2·NCT06421298·30 enrolled

Acute Myocardial Infarction1 trial

Effectiveness of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitor Initiation Before Percutaneous Coronary Intervention on Acute Myocardial Infarction Patients

Not yet recruiting·TThe Affiliated Hospital of Xuzhou Medical University·Phase 4·NCT06683131·1,160 enrolled

Extensive Stage Small Cell Lung Cancer (ES-SCLC)1 trial

Efficacy and Safety of Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer (STAR-SCLC)：A Prospective, Single Arm Trial

Recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 2·NCT07061535·40 enrolled

4 more indications

Bladder Urothelial Carcinoma1 trial

Study on Immunotherapy Enhancement Strategies for Muscle-invasive Bladder Cancer

Recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2·NCT07717242·80 enrolled

Hyperlipidemia1 trial

Efficacy and Safety of Tafolecimab With Different Dosing Intervals in Patients With Hyperlipidemia

Not yet recruiting·MMei Gao··NCT07712042·60 enrolled

Colorectal Carcinoma1 trial

Anti-PCSK9 Antibody Tafolecimab and Anti-PD-1 Antibody Sintilimab Combined With Neoadjuvant Chemoradiotherapy for pMMR/ MSS Locally Advanced Rectal Cancer : A Prospective, Multicenter, Randomized, Open-Label, Parallel-Controlled Trial

Not yet recruiting·GGuangdong Provincial People's Hospital·Phase 3·NCT07686796·148 enrolled

Unspecified1 trial

Bioequivalence Study of Tafolecimab Injections in Chinese Healthy Male Volunteers

Completed· Innovent Biologics (Suzhou) Co. Ltd. logo

Innovent Biologics (Suzhou) Co. Ltd.·Phase 1·NCT05792917·166 enrolled

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for Tafolecimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Tafolecimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Tafolecimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Innovent Biologics (Suzhou) Co. Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Innovent Biologics (Suzhou) Co. Ltd.

Tafolecimab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2027

Q4 2027

Q4 2028

Trials by Indication[1]

Acute Coronary Syndrome1 trial

Atherosclerosis1 trial

Non-Small Cell Lung Cancer1 trial

Acute Myocardial Infarction1 trial

Extensive Stage Small Cell Lung Cancer (ES-SCLC)1 trial

Bladder Urothelial Carcinoma1 trial

Hyperlipidemia1 trial

Colorectal Carcinoma1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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