BL-B01D1

Phase 3Small molecule

SSichuan Baili Pharmaceutical Co., Ltd.

BL-B01D1 is one of 440 small molecule programs targeting Chordoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

439

Competitors

Pipeline

Status by Indication[3][1]

Indication

ChordomaActive, not recruiting

Esophageal Squamous Cell CarcinomaActive, not recruiting

Nasopharyngeal CarcinomaActive, not recruiting

Triple-Negative Breast CancerActive, not recruiting

Biliary Tract CancerNot yet recruiting

Non-Small Cell Lung CancerActive, not recruiting

Breast CancerActive, not recruiting

Colorectal CancerActive, not recruiting

Ovarian CancerActive, not recruiting

Hepatocellular CarcinomaActive, not recruiting

ChordomaPhase 2

Active, not recruiting

Esophageal Squamous Cell CarcinomaPhase 3

Active, not recruiting

Nasopharyngeal CarcinomaPhase 3

Active, not recruiting

Triple-Negative Breast CancerPhase 2

Active, not recruiting

Biliary Tract CancerPhase 3

Not yet recruiting

Non-Small Cell Lung CancerPhase 2

Active, not recruiting

Breast CancerPhase 3

Active, not recruiting

Colorectal CancerPhase 2

Active, not recruiting

Ovarian CancerPhase 3

Active, not recruiting

Hepatocellular CarcinomaPhase 2

Active, not recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

BL-B01D1

SSichuan Baili Pharmaceutical Co., Ltd.

Phase 3

4 2

Tykerb

GSK

Preclinical

80 3

Adriamycin

GGynecologic Oncology Group

Preclinical

87 4

Prolia

Amgen

Preclinical

14 5

Gemzar

GGynecologic Oncology Group

Preclinical

22 6

Cymbalta

Alnylam Pharmaceuticals

Preclinical

3 7

Blenoxane

Bristol-Myers Squibb

Preclinical

1 8

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 9

Recentin

NNational Cancer Institute (NCI)

Preclinical

2 10

Chantix

PPrism Pharmaceuticals

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Phase 2Recruiting

Non-Small Cell Lung Cancer

NCT06498986

Q4 2026

Phase 2Recruiting

Glioblastoma

NCT06598787

Phase 3Active, not recruiting

Nasopharyngeal Carcinoma

NCT06118333

Q3 2027

Phase 2Active, not recruiting

Non-Small Cell Lung Cancer

NCT05880706

Q4 2027

Phase 2Recruiting

Biliary Tract Cancer

NCT06978114

Phase 2Recruiting

Hepatocellular Carcinoma

NCT06986785

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer8 trials

A Study Comparing BL-B01D1 With Platinum Based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT06382116·432 enrolled

A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06475300·570 enrolled

A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT05956587·121 enrolled

Show 5 more trials

A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT06838273·720 enrolled

A Study of BL-B01D1 and BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT05880706·198 enrolled

A Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT06382129·680 enrolled

Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors

Recruiting·SSystImmune Inc.·Phase 1·NCT05983432·470 enrolled

A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06498986·40 enrolled

Breast Cancer4 trials

A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT06343948·383 enrolled

A Study of BL-B01D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 1·NCT05470348·36 enrolled

A Study of SI-B003 or BL-B01D1+SI-B003 in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06042894·58 enrolled

Show 1 more trial

A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+/HER2- Breast Cancer After Failure of Prior Endocrine Therapy(PANKU-Breast03)

Not yet recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT07648914·446 enrolled

Small Cell Lung Cancer3 trials

A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06437509·66 enrolled

A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Extensive Stage Small Cell Lung Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT05924841·100 enrolled

A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT06500026·714 enrolled

Urothelial Carcinoma3 trials

A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Urothelial Carcinoma

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT06857175·508 enrolled

A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Other Solid Tumors

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT05965856·52 enrolled

A Study of BL-B01D1 + PD-1 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06405425·52 enrolled

Biliary Tract Cancer2 trials

A Study of BL-B01D1+PD-1/PD-L1 Monoclonal Antibody in Patients With Advanced Biliary Tract Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06978114·46 enrolled

A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy(PANKU-BTC01)

Not yet recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT07582315·538 enrolled

19 more indications

Head and Neck Squamous Cell Carcinoma2 trials

A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06006169·186 enrolled

A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06437522·46 enrolled

Triple-Negative Breast Cancer2 trials

A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06471205·52 enrolled

A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT06382142·418 enrolled

Esophageal Squamous Cell Carcinoma1 trial

A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT06304974·497 enrolled

Hepatocellular Carcinoma1 trial

A Study of BL-B01D1 Combined With Lenvatinib in Patients With Advanced Hepatocellular Carcinoma

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06986785·46 enrolled

Advanced or Metastatic Solid Tumor1 trial

A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 1·NCT05194982·570 enrolled

Endometrial Cancer1 trial

A Study of BL-B01D1 + Pembrolizumab ± Bevacizumab in Patients With Recurrent or Metastatic Cervical Cancer and Endometrial Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT07054567·96 enrolled

Rare Tumor1 trial

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

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

Gastrointestinal Tumor1 trial

A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 1·NCT05262491·96 enrolled

Colorectal Cancer1 trial

A Study of SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06008054·376 enrolled

Other Solid Tumors1 trial

A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Urological Tumors and Other Solid Tumors

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 1·NCT05393427·4 enrolled

Chordoma1 trial

A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Chordoma

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06787664·40 enrolled

Recurrent or Metastatic1 trial

A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Recurrent or Metastatic Gynecological Malignancies

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 1/2·NCT05803018·38 enrolled

Cervical Cancer1 trial

A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT05990803·130 enrolled

Urinary System Tumor1 trial

A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Locally Advanced or Metastatic Urinary System Tumors

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT05785039·76 enrolled

Glioblastoma1 trial

A Study of BL-B01D1 in Patients With Recurrent Glioblastoma

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06598787·20 enrolled

Resectable1 trial

A Study of BL-B01D1 and Almonertinib in Patients With Resectable EGFR+ Stage II-IIIB NSCLC

Recruiting·SSichuan University·Phase 2·NCT06951464·40 enrolled

Nasopharyngeal Carcinoma1 trial

A Study Comparing BL-B01D1 With Physician's Choice of Chemotherapy in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT06118333·386 enrolled

Locally Advanced1 trial

A Study of BL-B01D1+TKI±Pembrolizumab in Patients With Locally Advanced or Metastatic Renal Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06962787·260 enrolled

Epithelial Ovarian Cancer1 trial

A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT06994195·450 enrolled

Sources

References

[1]
ClinicalTrials.gov — 41 trial records for BL-B01D1. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — BL-B01D1 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for BL-B01D1. 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.

BL-B01D1

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q3 2027

Q4 2027

Trials by Indication[1]

Non-Small Cell Lung Cancer8 trials

Breast Cancer4 trials

Small Cell Lung Cancer3 trials

Urothelial Carcinoma3 trials

Biliary Tract Cancer2 trials

Head and Neck Squamous Cell Carcinoma2 trials

Triple-Negative Breast Cancer2 trials

Esophageal Squamous Cell Carcinoma1 trial

Hepatocellular Carcinoma1 trial

Advanced or Metastatic Solid Tumor1 trial

Endometrial Cancer1 trial

Rare Tumor1 trial

Gastrointestinal Tumor1 trial

Colorectal Cancer1 trial

Other Solid Tumors1 trial

Chordoma1 trial

Recurrent or Metastatic1 trial

Cervical Cancer1 trial

Urinary System Tumor1 trial

Glioblastoma1 trial

Resectable1 trial

Nasopharyngeal Carcinoma1 trial

Locally Advanced1 trial

Epithelial Ovarian Cancer1 trial

References

Drug Info

Quick Facts

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