SI-B001

Phase 3Small molecule

SSichuan Baili Pharmaceutical Co., Ltd.

SI-B001 is one of 116 small molecule programs targeting Esophageal Squamous Cell Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

115

Competitors

Pipeline

Status by Indication[3][1]

Indication

Esophageal Squamous Cell CarcinomaActive, not recruiting

Non-Small Cell Lung AdenocarcinomaActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Head and Neck Squamous Cell CarcinomaActive, not recruiting

Esophageal Squamous Cell CarcinomaPhase 2

Active, not recruiting

Non-Small Cell Lung AdenocarcinomaPhase 3

Active, not recruiting

Non-Small Cell Lung CancerPhase 2/Phase 3

Active, not recruiting

Head and Neck Squamous Cell CarcinomaPhase 1/Phase 2

Active, not recruiting

Competition

Competitive Landscape

1639 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

SI-B001

SSichuan Baili Pharmaceutical Co., Ltd.

Phase 3

2 2

Yervoy

Bristol-Myers Squibb

Preclinical

31 3

Gemzar

GGynecologic Oncology Group

Preclinical

72 4

Gilotrif

Boehringer Ingelheim

Preclinical

12 5

Ofev

Boehringer Ingelheim

Preclinical

7 6

Remeron

OOrganon and Co

Preclinical

1 7

Treatment

GSK

Preclinical

1 8

Vidaza

Bristol-Myers Squibb

Preclinical

1 9

Vibramycin

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

Preclinical

—10

Immune Checkpoint Inhibitors

PPeking Union Medical College Hospital

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Head and Neck Squamous Cell Carcinoma

NCT06668961

Q4 2027

Phase 1/2Recruiting

Non-Small Cell Lung Cancer

NCT05949606

Phase 1/2Recruiting

Head and Neck Squamous Cell Carcinoma

NCT05668858

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer2 trials

A Study of SI-B001+SI-B003± Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 1/2·NCT05949606·160 enrolled

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

Head and Neck Squamous Cell Carcinoma2 trials

A Study of SI-B001+SI-B003 Combined With Platinum-based Chemotherapy as First-line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06668961·60 enrolled

A Study of SI-B001+SI-B003± Chemotherapy in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 1/2·NCT05668858·130 enrolled

Paclitaxel1 trial

A Clinical Study of SI-B001 in Combination With Paclitaxel in the Treatment of Recurrent and Metastatic HNSCC

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT05054439·42 enrolled

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

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

4 more indications

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

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

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

Paclitaxel1 trial

Locally Advanced or Metastatic Epithelial Tumor1 trial

Efficacy and Safety1 trial

Chemotherapy1 trial

Recurrent or Metastatic1 trial

Non-Small Cell Lung Adenocarcinoma1 trial

Esophageal Squamous Cell Carcinoma1 trial

References

Drug Info

Quick Facts

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