SI-B001

Phase 3Small molecule

SI-B001 is one of 184 small molecule programs targeting Head and Neck Squamous Cell Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

183

Competitors

Pipeline

Status by Indication[3][1]

Indication

Head and Neck Squamous Cell CarcinomaActive, not recruiting

Squamous Cell Carcinoma of Head and NeckActive, not recruiting

Locally Advanced or Metastatic Epithelial TumorActive, not recruiting

Efficacy and SafetyActive, not recruiting

Esophageal Squamous Cell CarcinomaActive, not recruiting

Non-Small Cell Lung AdenocarcinomaActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Recurrent or MetastaticActive, not recruiting

Head and Neck Squamous Cell CarcinomaPhase 2

Active, not recruiting

Squamous Cell Carcinoma of Head and NeckPreclinical

Active, not recruiting

Locally Advanced or Metastatic Epithelial TumorPhase 1

Active, not recruiting

Efficacy and SafetyPhase 2

Active, not recruiting

Esophageal Squamous Cell CarcinomaPhase 2

Active, not recruiting

Non-Small Cell Lung AdenocarcinomaPhase 3

Active, not recruiting

Non-Small Cell Lung CancerPhase 3

Active, not recruiting

Recurrent or MetastaticPhase 2

Active, not recruiting

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Alecensa

Roche

Phase 3

22 2

SI-B001

SSichuan Baili Pharmaceutical Co., Ltd.

Phase 3

2 3

Carboplatin or Cisplatin

SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Phase 3

4 4

Second-Line Systemic Therapy

SSun Yat-sen University

Phase 3

1 5

Remeron

OOrganon and Co

Preclinical

1 6

Vibramycin

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

Treatment

1 8

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—9

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

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 2Active, not recruiting

Head and Neck Squamous Cell Carcinoma

NCT06668961

Phase 2Active, not recruiting

Head and Neck Squamous Cell Carcinoma

NCT05054439

Q4 2027

PreclinicalActive, not recruiting

Squamous Cell Carcinoma of Head and Neck

NCT05668858

PreclinicalActive, not recruiting

Non-Small Cell Lung Cancer

NCT05949606

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer2 trials

SI-B001 Combined With Osimertinib Mesylate Tablets in the Treatment of Recurrent Metastatic Non-small Cell Lung Cancer.

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2/3·NCT05020769·14 enrolled

A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of SI-B001+SI-B003 With or Without Chemotherapy (SI-B001+SI-B003± Chemotherapy) in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Preclinical·NCT05949606·95 enrolled

Head and Neck Squamous Cell Carcinoma2 trials

A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in Combination With Paclitaxel/Docetaxel in the Treatment of Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT05054439·45 enrolled

A Phase II Clinical Study to Evaluate the Safety and Efficacy of SI-B001+SI-B003 Combined With Platinum-based Chemotherapy (SI-B001+SI-B003+ Platinum-based Chemotherapy) as First-line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06668961·48 enrolled

Recurrent or Metastatic1 trial

SI-B001 Combined With Chemotherapy in the Treatment of EGFR/ALK WT Recurrent or Metastatic NSCLC.

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT05020457·69 enrolled

Non-Small Cell Lung Adenocarcinoma1 trial

A Clinical Study of SI-B001 Combined With Docetaxel in the Treatment of Non-small Cell Lung Adenocarcinoma and Lung Squamous Cell Carcinoma

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT05943795·589 enrolled

Esophageal Squamous Cell Carcinoma1 trial

SI-B001 Combined With Irinotecan in the Treatment of Recurrent Metastatic Esophageal Squamous Cell Carcinoma.

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT05022654·22 enrolled

4 more indications

Locally Advanced or Metastatic Epithelial Tumor1 trial

A Study of SI-B001, an EGFR/HER3 Bispecific Antibody, in Locally Advanced or Metastatic Epithelial Tumors

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 1·NCT04603287·60 enrolled

Chemotherapy1 trial

SI-B001 as a Single Agent or in Combination With Chemotherapy in the Treatment of Digestive System Malignancies

Terminated·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT05039944·7 enrolled

Efficacy and Safety1 trial

A Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in the Treatment of Recurrent and Metastatic HNSCC

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT05044897·11 enrolled

Squamous Cell Carcinoma of Head and Neck1 trial

A Phase Ib/II Clinical Study of SI-B001+SI-B003 Dual-drug No-combination or Combined Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Preclinical·NCT05668858·70 enrolled

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for SI-B001. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — SI-B001 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for SI-B001. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Sichuan Baili Pharmaceutical 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: SSichuan Baili Pharmaceutical Co., Ltd.

SI-B001

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Trials by Indication[1]

Non-Small Cell Lung Cancer2 trials

Head and Neck Squamous Cell Carcinoma2 trials

Recurrent or Metastatic1 trial

Non-Small Cell Lung Adenocarcinoma1 trial

Esophageal Squamous Cell Carcinoma1 trial

Locally Advanced or Metastatic Epithelial Tumor1 trial

Chemotherapy1 trial

Efficacy and Safety1 trial

Squamous Cell Carcinoma of Head and Neck1 trial

References

Drug Info

Quick Facts

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