PM8002

Phase 3Biologic

BBiotheus Inc.

PM8002 is one of 132 biologic programs targeting Metastatic Colorectal Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

131

Competitors

Pipeline

Status by Indication[3][1]

Indication

Metastatic Colorectal CancerActive, not recruiting

Neuroendocrine NeoplasmActive, not recruiting

Hepatocellular CarcinomaActive, not recruiting

Small Cell Lung CancerActive, not recruiting

Metastatic Colorectal CancerPhase 2

Active, not recruiting

Neuroendocrine NeoplasmPhase 2

Active, not recruiting

Hepatocellular CarcinomaPhase 2

Active, not recruiting

Small Cell Lung CancerPhase 3

Active, not recruiting

Competition

Competitive Landscape

797 competitors in Hepatocellular Carcinoma

#DrugCompanyPhaseTrials

PM8002

BBiotheus Inc.

Phase 3

1 2

Viread

Gilead

Preclinical

1 3

Ibrance

Pfizer

Preclinical

1 4

Cysteine Hydrochloride

Novartis

Preclinical

1 5

Sovaldi

Gilead

Preclinical

1 6

Hepsera

Coreg

2 8

Apatinib

LLaNova Medicines Zhejiang Co., Ltd.

Preclinical

16 9

Opdivo

Bristol-Myers Squibb

Preclinical

2 10

PD-1 Inhibitor

Johnson & Johnson

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 1/2Active, not recruiting

First Line Therapy

NCT05918133

Q4 2027

Phase 1/2Not yet recruiting

First-Line

NCT06584071

Q1 2028

Phase 2Active, not recruiting

Neuroendocrine Neoplasm

NCT05879055

Q3 2028

Phase 3Recruiting

First-Line Treatment

NCT06419621

Clinical

Trials by Indication[1]

Chemotherapy3 trials

A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With NSCLC

Active, not recruiting·BBiotheus Inc.·Phase 2·NCT05756972·64 enrolled

A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC

Active, not recruiting·BBiotheus Inc.·Phase 2·NCT05879068·99 enrolled

A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC

Active, not recruiting·BBiotheus Inc.·Phase 2·NCT05844150·50 enrolled

First Line Therapy2 trials

A Study of PM8002 Plus Nab-paclitaxel as First Line Therapy for TNBC

Active, not recruiting·BBiotheus Inc.·Phase 1/2·NCT05918133·42 enrolled

A Study of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in MPM

Recruiting·BBiotheus Inc.·Phase 2·NCT05918107·55 enrolled

First-line1 trial

A Study to Evaluate of PM8002 Combined With PM1009 in Patients With First-line HCC

Not yet recruiting·BBiotheus Inc.·Phase 1/2·NCT06584071·140 enrolled

Metastatic Colorectal Cancer1 trial

PM8002 (BNT327) in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancer

Not yet recruiting·BBiotheus Inc.·Phase 2·NCT07133750·40 enrolled

Small Cell Lung Cancer1 trial

PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer

Recruiting·BBiotheus Inc.·Phase 3·NCT06616532·404 enrolled

5 more indications

Patients With Advanced Solid Tumors1 trial

PM8002 in the Treatment of Patients With Advanced Solid Tumors

Recruiting·BBiotheus Inc.·Phase 1/2·NCT05918445·380 enrolled

Neoadjuvant Chemotherapy1 trial

Neoadjuvant Chemotherapy Combined With Bispecific Antibody Versus Monoclonal Antibody in Locally Advanced NSCLC

Not yet recruiting·SShanghai Pulmonary Hospital, Shanghai, China·Phase 2·NCT06837948·160 enrolled

First-line Treatment1 trial

PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC

Recruiting·BBiotheus Inc.·Phase 3·NCT06419621·360 enrolled

Neuroendocrine Neoplasm1 trial

A Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PM8002 Injection in Combination With Chemotherapy as Second Line Therapy in Unresectable Neuroendocrine Neoplasm

Active, not recruiting·BBiotheus Inc.·Phase 2·NCT05879055·31 enrolled

Hepatocellular Carcinoma1 trial

A Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in Unresectable Hepatocellular Carcinoma

Completed·BBiotheus Inc.·Phase 2·NCT05864105·35 enrolled

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for PM8002. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — PM8002 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for PM8002. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Biotheus Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Biologic[2]
Highest Phase: Phase 3[1]
Company: BBiotheus Inc.

PM8002

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q1 2028

Q3 2028

Trials by Indication[1]

Chemotherapy3 trials

First Line Therapy2 trials

First-line1 trial

Metastatic Colorectal Cancer1 trial

Small Cell Lung Cancer1 trial

Patients With Advanced Solid Tumors1 trial

Neoadjuvant Chemotherapy1 trial

First-line Treatment1 trial

Neuroendocrine Neoplasm1 trial

Hepatocellular Carcinoma1 trial

References

Drug Info

Quick Facts

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