IBI363

Phase 3Small molecule

Innovent Biologics (Suzhou) Co. Ltd.

IBI363 is one of 361 small molecule programs targeting Non-Small Cell Lung Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

360

Competitors

Pipeline

Status by Indication[3][1]

Indication

Non-Small Cell Lung CancerRecruiting

Gastric CancerRecruiting

Non-Squamous Non-Small Cell Lung CancerRecruiting

Solid TumorActive, not recruiting

Advanced MalignanciesRecruiting

Advanced Solid MalignanciesRecruiting

LymphomaActive, not recruiting

MelanomaRecruiting

Pancreatic CancerNot yet recruiting

Colorectal CancerRecruiting

Non-Small Cell Lung CancerPhase 2

Recruiting

Gastric CancerPhase 2

Recruiting

Non-Squamous Non-Small Cell Lung CancerPhase 2

Recruiting

Solid TumorPhase 1

Active, not recruiting

Advanced MalignanciesPhase 1

Recruiting

Advanced Solid MalignanciesPhase 2

Recruiting

LymphomaPhase 1

Active, not recruiting

MelanomaPhase 2

Recruiting

Pancreatic CancerPhase 2

Not yet recruiting

Colorectal CancerPhase 3

Recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Tiragolumab

Roche

Phase 3

9 2

IBI363

Innovent Biologics (Suzhou) Co. Ltd.

Phase 3

3 3

SYS6010

CCSPC Megalith Biopharmaceutical Co.,Ltd.

Phase 3

2 4

Divarasib

Roche

Phase 3

7 5

Remeron

OOrganon and Co

Preclinical

1 6

Treatment

GSK

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.

Preclinical

—10

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Advanced Malignancies

NCT06468098

Phase 1Active, not recruiting

Lymphoma

NCT05290597

Phase 2Recruiting

Advanced Solid Malignancies

NCT06281678

Phase 1Recruiting

Gastric Cancer

NCT06610799

Q2 2027

Phase 2Recruiting

Melanoma

NCT06797297

Phase 1Active, not recruiting

Solid Tumor

NCT05460767

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer3 trials

IBI363 as Neoadjuvant Therapy in Resectable Stage II-III Non-Small Cell Lung Cancer

Not yet recruiting· Innovent Biologics (Suzhou) Co. Ltd. logo

Innovent Biologics (Suzhou) Co. Ltd.·Phase 2·NCT07402070·10 enrolled

IBI363 (PD-1/IL-2α-bias) in Combination With Chemotherapy as Neoadjuvant Therapy in Initially Unresectable Stage III Non-Small Cell Lung Cancer

Recruiting·SShanghai Pulmonary Hospital, Shanghai, China·Phase 2·NCT07408635·43 enrolled

Efficacy of PD-1 Inhibitor Combination Therapy in Non-small Cell Lung Cancer Patients Who Have Not Achieved Major Pathologic Response After Neoadjuvant Immunotherapy: a Multicenter, Phase II Clinical Trial

Not yet recruiting·SShanghai Pulmonary Hospital, Shanghai, China·Phase 2·NCT06620822·296 enrolled

Gastric Cancer3 trials

IBI363 Plus Bevacizumab With or Without Nab-Paclitaxel for Second-Line Treatment of Advanced Gastric Cancer

Not yet recruiting·TThe First Affiliated Hospital of Zhengzhou University·Phase 1/2·NCT07361991·50 enrolled

Perioprative Study of IBI363 in Patients With MHC-II-Negative Locally Advanced Gastric Cancer

Recruiting·ZZhejiang Cancer Hospital·Phase 2·NCT07325630·60 enrolled

Study of IBI363 in Patients with Advanced First-line Gastric Cancer

Recruiting·XXiangdong Cheng·Phase 1·NCT06610799·40 enrolled

Melanoma2 trials

A Study to Evaluate the Efficacy and Safety of IBI363 Monotherapy Compared to Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic Mucosal or Acral Melanoma Who Had Not Previously Received Systemic Therapy

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

Innovent Biologics (Suzhou) Co. Ltd.·Phase 2·NCT06797297·180 enrolled

A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of IBI363 in Subjects With Advanced Melanoma

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

Innovent Biologics (Suzhou) Co. Ltd.·Phase 2·NCT06081920·180 enrolled

Efficacy and Safety1 trial

The Efficacy and Safety of IBI363 in Solid Tumors

Recruiting·HHunan Province Tumor Hospital·Phase 1/2·NCT06081907·430 enrolled

Advanced Malignancies1 trial

A Study of IBI363 in Subjects With Advanced Malignancies

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

Innovent Biologics (Suzhou) Co. Ltd.·Phase 1·NCT06468098·556 enrolled

8 more indications

Rare Tumor1 trial

Rare Tumor Focused Platform Study of Innovative Therapies and Technologies (PLATFORM2)

Not yet recruiting·—·Phase 1/2·NCT07307053·600 enrolled

Pancreatic Cancer1 trial

Phase Ib/II Study to Evaluate the Safety and Efficacy of IBI363 in Combination With Chemotherapy as Second-Line Therapy for Unresectable Locally Advanced or Metastatic Pancreatic Cancer

Not yet recruiting·RRuijin Hospital·Phase 1/2·NCT07342725·48 enrolled

Lymphoma1 trial

A Phase 1, Open-label, Multicenter, Dose Escalation Study of IBI363 (PD1-IL2m) in Subjects With Advanced Solid Malignancies or Lymphomas

Active, not recruiting· Innovent Biologics (Suzhou) Co. Ltd. logo

Innovent Biologics (Suzhou) Co. Ltd.·Phase 1·NCT05290597·40 enrolled

Advanced Solid Malignancies1 trial

A Study of IBI363 in Subjects with Advanced Solid Malignancies

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

Innovent Biologics (Suzhou) Co. Ltd.·Phase 2·NCT06281678·178 enrolled

Solid Tumor1 trial

A Phase Ia/Ib Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma

Active, not recruiting· Innovent Biologics (Suzhou) Co. Ltd. logo

Innovent Biologics (Suzhou) Co. Ltd.·Phase 1·NCT05460767·504 enrolled

Colorectal Cancer1 trial

A Randomized, Open-label, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of IBI363 in Combination With Bevacizumab Versus Investigator's Choice of Therapy in Participants With Advanced Colorectal Cancer Who Have Failed or Are Intolerant to Standard Care of Therapy

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

Innovent Biologics (Suzhou) Co. Ltd.·Phase 3·NCT07722494·550 enrolled

IO-resistant sqNSCLC1 trial

A Randomized, Open Label, Multicenter, Phase 3 Trial Evaluating the Efficacy and Safety of TAK-928 Versus Docetaxel in Participants With Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Disease Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy

Recruiting·FFortvita Biologics (USA)Inc.·Phase 3·NCT07217301·600 enrolled

Non-Squamous Non-Small Cell Lung Cancer1 trial

A Phase II Study Evaluating the Efficacy and Safety of IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer

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

Innovent Biologics (Suzhou) Co. Ltd.·Phase 2·NCT07122687·170 enrolled

Sources

References

[1]
ClinicalTrials.gov — 18 trial records for IBI363. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — IBI363 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for IBI363. 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: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Innovent Biologics (Suzhou) Co. Ltd.

IBI363

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Trials by Indication[1]

Non-Small Cell Lung Cancer3 trials

Gastric Cancer3 trials

Melanoma2 trials

Efficacy and Safety1 trial

Advanced Malignancies1 trial

Rare Tumor1 trial

Pancreatic Cancer1 trial

Lymphoma1 trial

Advanced Solid Malignancies1 trial

Solid Tumor1 trial

Colorectal Cancer1 trial

IO-resistant sqNSCLC1 trial

Non-Squamous Non-Small Cell Lung Cancer1 trial

References

Drug Info

Quick Facts

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