BL-B01D1

Phase 3Small molecule

SSichuan Baili Pharmaceutical Co., Ltd.

BL-B01D1 is one of 538 small molecule programs targeting Triple-Negative Breast Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

537

Competitors

Pipeline

Status by Indication[3][1]

Indication

Triple-Negative Breast CancerActive, not recruiting

Epithelial Ovarian CancerRecruiting

HR+/HER2- Breast CancerActive, not recruiting

Castration-Resistant Prostate CancerNot yet recruiting

Extensive-Stage Small-Cell Lung CancerRecruiting

Triple Negative Breast Cancer (TNBC)Not yet recruiting

Squamous Non-Small-Cell Lung CancerNot yet recruiting

Non-Squamous Non-Small Cell Lung CancerNot yet recruiting

Urinary System TumorRecruiting

Advanced or Metastatic Solid TumorRecruiting

Triple-Negative Breast CancerPhase 3

Active, not recruiting

Epithelial Ovarian CancerPhase 3

Recruiting

HR+/HER2- Breast CancerPhase 3

Active, not recruiting

Castration-Resistant Prostate CancerPreclinical

Not yet recruiting

Extensive-Stage Small-Cell Lung CancerPhase 3

Recruiting

Triple Negative Breast Cancer (TNBC)Phase 3

Not yet recruiting

Squamous Non-Small-Cell Lung CancerPreclinical

Not yet recruiting

Non-Squamous Non-Small Cell Lung CancerPreclinical

Not yet recruiting

Urinary System TumorPhase 2

Recruiting

Advanced or Metastatic Solid TumorPhase 1

Recruiting

Showing 10 of 30 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

BL-B01D1

SSichuan Baili Pharmaceutical Co., Ltd.

Phase 3

3 2

Adenocard

Astellas

Preclinical

2 3

Voltaren

Novartis

Preclinical

1 4

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 5

Vit D

PPost Graduate Institute of Medical Education and Research, Chandigarh

Preclinical

1 6

Tianeptine

Pfizer

Preclinical

1 7

Ablavar

LLantheus Medical Imaging

Preclinical

2 8

Recombinant Human Endostatin

PPeking University Third Hospital

Preclinical

1 9

Naltrexone/bupropion

Novo Nordisk

Preclinical

1 10

Liposomal Irinotecan and Apatinib

SSecond Affiliated Hospital, School of Medicine, Zhejiang University

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Glioblastoma

NCT06598787

Phase 3Active, not recruiting

Nasopharyngeal Carcinoma

NCT06118333

Q2 2027

Phase 3Active, not recruiting

Esophageal Squamous Cell Carcinoma

NCT06304974

Q3 2027

Phase 2Active, not recruiting

Non-Small Cell Lung Cancer

NCT05880706

Q4 2027

Phase 2Recruiting

Breast Cancer

NCT06042894

Phase 2Recruiting

Endometrial Cancer

NCT07054567

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer10 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

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

Show 7 more trials

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 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

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

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 for Injection Combined With Glecirasib in Patients With KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Not yet recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT07827261·36 enrolled

A Phase II/III Randomized Controlled Clinical Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU-Lung09)

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Preclinical·NCT07642024·90 enrolled

A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Platinum Based Chemotherapy (First-line of Systemic Treatment) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After EGFR-TKI Failure

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

A Phase II Clinical Trial to Evaluate the Efficacy and Safety 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

Breast Cancer3 trials

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

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy 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 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)

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT07648914·446 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 Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 + PD-1 Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

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

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 Phase II Clinical Trial To Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (Non-nasopharyngeal Carcinoma) and Other Solid Tumors

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

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT07582315·538 enrolled

27 more indications

Small Cell Lung Cancer2 trials

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

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1 Monotherapy, SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Extensive Stage Small Cell Lung Cancer (SCLC)

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

Nasopharyngeal Carcinoma (NPC)2 trials

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 With or Without PD-1 Monoclonal Antibody in Patients With High-Risk Locally Advanced Nasopharyngeal Carcinoma

Not yet recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT07797881·60 enrolled

A Phase III Randomized Controlled Clinical Study of Anti-PD-1 Antibody With or Without BL-B01D1 as Maintenance Therapy Following Anti-PD-1 Antibody Plus Chemotherapy for the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma (PANKU-NPC02)

Not yet recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT07783321·404 enrolled

Extensive-stage Small-cell Lung Cancer2 trials

A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 for Injection Combined With Tislelizumab Versus Platinum-containing Chemotherapy Combined With Tislelizumab as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT07502300·562 enrolled

A Phase II Clinical Trial to Evaluate the Efficacy and Safety 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

Triple-Negative Breast Cancer2 trials

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody Combination Therapy 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 Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer After Taxane Failure

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

Esophageal Squamous Cell Carcinoma2 trials

A Phase Ill Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice as Second Line Treatment in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma After Failure of PD-1/PD-L1 Monoclonal Antibody in Combination With Platinum-based Chemotherapy

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

A Phase II/III Randomized Controlled Clinical Study of BL-B01D1 for Injection in Combination With Tislelizumab With or Without 5-Fluorouracil Versus Platinum-Based Chemotherapy Plus Tislelizumab as First-line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(PANKU-Esophagus02)

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Preclinical·NCT07554456·90 enrolled

Glioblastoma1 trial

A Study of BL-B01D1 in Patients With Recurrent Glioblastoma

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

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

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

Rare Tumor1 trial

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

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

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

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

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

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

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

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

Non-small Cell Lung Cancer Stage III1 trial

A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy(PANKU-Lung08)

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT07640789·418 enrolled

Urinary System Tumor1 trial

Phase IIa/IIb Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-B01D1 for Injection 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

Gastrointestinal Tumor1 trial

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy 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

Advanced or Metastatic Solid Tumor1 trial

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor

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

Non-Squamous Non-Small Cell Lung Cancer1 trial

A Randomized, Open-label, Multicenter Phase II/III Clinical Study Evaluating BL-B01D1 in Combination With a PD-1/VEGF Bispecific Antibody Versus Tislelizumab Plus Platinum-doublet Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer(PANKU-Lung06)

Not yet recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Preclinical·NCT07739186·120 enrolled

Triple Negative Breast Cancer (TNBC)1 trial

A Phase III Randomized Controlled Clinical Study of BL-B01D1 Plus an Anti-PD-1 Antibody Versus Nab-paclitaxel Plus an Anti-PD-1 Antibody in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Express PD-L1 (PANKU-Breast04)

Not yet recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT07729956·436 enrolled

Squamous Non-small-cell Lung Cancer1 trial

A Phase II/III Clinical Study Comparing BL-B01D1 in Combination With PD-1/VEGF Bispecific Antibody Versus Chemotherapy in Combination With PD-1/VEGF Bispecific Antibody in First-line Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer(PANKU-Lung05)

Not yet recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Preclinical·NCT07739199·200 enrolled

Castration-resistant Prostate Cancer1 trial

A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 Combination Therapy in Patients With Metastatic Castration-resistant Prostate Cancer

Not yet recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Preclinical·NCT07641855·180 enrolled

HR+/HER2- Breast Cancer1 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 at Least One Prior Line of Chemotherapy

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT06343948·383 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 — 52 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

Q4 2026

Q2 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Non-Small Cell Lung Cancer10 trials

Breast Cancer3 trials

Urothelial Carcinoma3 trials

Head and Neck Squamous Cell Carcinoma2 trials

Biliary Tract Cancer2 trials

Small Cell Lung Cancer2 trials

Nasopharyngeal Carcinoma (NPC)2 trials

Extensive-stage Small-cell Lung Cancer2 trials

Triple-Negative Breast Cancer2 trials

Esophageal Squamous Cell Carcinoma2 trials

Glioblastoma1 trial

Endometrial Cancer1 trial

Hepatocellular Carcinoma1 trial

Other Solid Tumors1 trial

Rare Tumor1 trial

Resectable1 trial

Chordoma1 trial

Locally Advanced1 trial

Cervical Cancer1 trial

Colorectal Cancer1 trial

Recurrent or Metastatic1 trial

Nasopharyngeal Carcinoma1 trial

Non-small Cell Lung Cancer Stage III1 trial

Urinary System Tumor1 trial

Gastrointestinal Tumor1 trial

Advanced or Metastatic Solid Tumor1 trial

Non-Squamous Non-Small Cell Lung Cancer1 trial

Triple Negative Breast Cancer (TNBC)1 trial

Squamous Non-small-cell Lung Cancer1 trial

Castration-resistant Prostate Cancer1 trial

HR+/HER2- Breast Cancer1 trial

Epithelial Ovarian Cancer1 trial

References

Drug Info

Quick Facts

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