PD-1 monoclonal antibody

Phase 3Small molecule

SSichuan Baili Pharmaceutical Co., Ltd.

PD-1 monoclonal antibody is one of 323 small molecule programs targeting Lymphoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

322

Competitors

Pipeline

Status by Indication[3][1]

Indication

LymphomaActive, not recruiting

Colorectal CancerRecruiting

Rectal AdenocarcinomaRecruiting

Extensive-Stage Small-Cell Lung CancerRecruiting

Triple Negative Breast Cancer (TNBC)Not yet recruiting

Gastric or Gastroesophageal Junction AdenocarcinomaActive, not recruiting

Nasopharyngeal CarcinomaRecruiting

Triple-Negative Breast CancerRecruiting

Non-Small Cell Lung CancerRecruiting

Hepatocellular CarcinomaNot yet recruiting

LymphomaPreclinical

Active, not recruiting

Colorectal CancerPhase 3

Recruiting

Rectal AdenocarcinomaPhase 3

Recruiting

Extensive-Stage Small-Cell Lung CancerPhase 2

Recruiting

Triple Negative Breast Cancer (TNBC)Phase 3

Not yet recruiting

Gastric or Gastroesophageal Junction AdenocarcinomaPhase 2

Active, not recruiting

Nasopharyngeal CarcinomaPhase 2

Recruiting

Triple-Negative Breast CancerPhase 2

Recruiting

Non-Small Cell Lung CancerPhase 2

Recruiting

Hepatocellular CarcinomaPhase 1

Not yet recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Navelbine

PPierre Fabre Medicament

Phase 3

24 2

Pyrotinib

HHengrui Therapeutics, Inc.

Phase 3

3 3

PD-1 monoclonal antibody

SSichuan Baili Pharmaceutical Co., Ltd.

Phase 3

1 4

HLX17

Shanghai Henlius Biotech

Phase 3

2 5

Remeron

OOrganon and Co

Preclinical

1 6

Treatment

GSK

Preclinical

1 7

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

1 8

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—9

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—10

Vibramycin

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

Preclinical

—

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

Timeline

Expected Milestones

Q3 2026

Phase 1Not yet recruiting

Hepatocellular Carcinoma

NCT06364800

Phase 1Not yet recruiting

Hepatocellular Carcinoma

NCT06364787

Q4 2026

Phase 2Active, not recruiting

Gastric or Gastroesophageal Junction Adenocarcinoma

NCT06423885

Q1 2027

Phase 3Recruiting

Colorectal Cancer

NCT06794086

Q4 2027

Phase 2Recruiting

Colorectal Cancer

NCT06008054

Phase 2Recruiting

Extensive-Stage Small-Cell Lung Cancer

NCT06437509

Clinical

Trials by Indication[1]

Hepatocellular Carcinoma3 trials

Allogeneic Gamma-delta T Cells Combined With Targeted Therapy and Immunotherapy in a Phase 1 Clinical Trial of Hepatocellular Carcinoma Resistant to PD-1 Monoclonal Antibody

Not yet recruiting·—·Phase 1·NCT06364800·18 enrolled

Precision Adjuvant Therapy After Surgery for Hepatocellular Carcinoma

Recruiting·CChen Xiaoping·Phase 4·NCT06311929·300 enrolled

Allogeneic Gamma-delta T Cells Combined With Targeted Therapy and Immunotherapy in a Phase 1 Clinical Trial for First-line Treatment of Hepatocellular Carcinoma

Not yet recruiting·—·Phase 1·NCT06364787·18 enrolled

Rectal Adenocarcinoma3 trials

Neoadjuvant Chemoradiotherapy and Immunotherapy Combined With Ketogenic Diet and/or High-Dose Intravenous Vitamin C in pMMR/MSS Locally Advanced Rectal Adenocarcinoma: A Prospective, Multicenter, Phase Ⅱ Clinical Study (CRI-KEV Trial)

Not yet recruiting·SSixth Affiliated Hospital, Sun Yat-sen University·Phase 2·NCT07765667·100 enrolled

Short-Course Radiotherapy Combined With mFOLFOX6, PD-1 Antibody and Cetuximab (for RAS/BRAF Wild-Type)/Bevacizumab (for RAS/BRAF Mutant) in High-Risk pMMR/MSS Rectal Adenocarcinoma: a Prospective, Multicenter Phase II Study(CRIT)

Completed·SSixth Affiliated Hospital, Sun Yat-sen University·Phase 2·NCT06908031·49 enrolled

Recruiting·SSixth Affiliated Hospital, Sun Yat-sen University·Phase 3·NCT07549399·204 enrolled

Colorectal Cancer2 trials

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

SBRT Combined With PD-1 Monoclonal Antibody in Unresectable Colorectal Liver Metastases: A Prospective, Multicenter, Single-arm, Phase II Clinical Study (SPARKLE-L)

Recruiting·JJun Huang·Phase 3·NCT06794086·24 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

Nasopharyngeal Carcinoma1 trial

A Phase II Trial Comparing Immunotherapy Versus Capecitabine Maintenance After Chemo-chemoradiotherapy for High-risk Nasopharyngeal Carcinoma

Recruiting·SSun Yat-sen University·Phase 2·NCT07392320·142 enrolled

15 more indications

First Line Therapy1 trial

Programmed Cell Death Protein-1 (PD-1) Monoclonal Antibody for EBV-HLH and CAEBV as First-line Therapy

Unknown status·TThe First Affiliated Hospital of Soochow University·Phase 4·NCT05039580·36 enrolled

Patients With Advanced Solid Tumors1 trial

Safety, Tolerability, and Pharmacokinetics of MW11 in Patients With Advanced Solid Tumors

Unknown status·MMabwell (Shanghai) Bioscience Co., Ltd.·Phase 1·NCT04478461·21 enrolled

Gastric Adenocarcinoma1 trial

PD-1 Monoclonal Antibody Combined With FLOT Regimen for Neoadjuvant Therapy of Gastric Adenocarcinoma

Unknown status·HHenan Cancer Hospital·Phase 2·NCT04341857·25 enrolled

Gastric Cancer1 trial

Synergistic Effects of PD-1 Antibody and Chemotherapy/Targeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-metastatic Gastric Cancer

Recruiting·SShanghai Zhongshan Hospital·Phase 2·NCT06468280·84 enrolled

Lymphoma1 trial

Chemotherapy Plus PD-1 Monoclonal Antibody in the Treatment of Refractory or Relapsed Peripheral T-cell Lymphoma.

Unknown status·OOu Bai, MD/PHD·N/A·NCT05821192·34 enrolled

Monoclonal1 trial

PD-1 Monoclonal Antibody in Pre-treated Lymphoepithelioma-like Carcinoma

Unknown status·GGuangzhou University of Traditional Chinese Medicine·N/A·NCT04430166·12 enrolled

Ablation1 trial

Ablation Combined With PD-1 in HCC: Phase II Study

Unknown status·SSun Yat-sen University·Phase 1/2·NCT04652440·30 enrolled

Chemoradiotherapy1 trial

Neoadjuvant Long-course Chemoradiotherapy Followed by Immunotherapy for Locally Advanced Mid-low Rectal Cancer

Completed·PPeking University People's Hospital·Phase 2·NCT06493240·30 enrolled

Solid Tumors1 trial

Chimeric Antigen Receptor T Cells Targeting claudin18.2 in Solid Tumors.

Completed·PPeking University·Phase 1·NCT03874897·134 enrolled

Gastric or Gastroesophageal Junction Adenocarcinoma1 trial

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-M07D1 Combination Therapy in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Gastric or Gastroesophageal Junction Adenocarcinoma

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 2·NCT06423885·64 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

Triple-Negative Breast Cancer1 trial

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

Extensive-stage Small-cell Lung Cancer1 trial

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

Head and Neck Squamous Cell Carcinoma1 trial

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

Non-Small Cell Lung Cancer1 trial

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

Sources

References

[1]
ClinicalTrials.gov — 26 trial records for PD-1 monoclonal antibody. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — PD-1 monoclonal antibody compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for PD-1 monoclonal antibody. 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.

PD-1 monoclonal antibody

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2027

Q4 2027

Trials by Indication[1]

Hepatocellular Carcinoma3 trials

Rectal Adenocarcinoma3 trials

Colorectal Cancer2 trials

Nasopharyngeal Carcinoma (NPC)2 trials

Nasopharyngeal Carcinoma1 trial

First Line Therapy1 trial

Patients With Advanced Solid Tumors1 trial

Gastric Adenocarcinoma1 trial

Gastric Cancer1 trial

Lymphoma1 trial

Monoclonal1 trial

Ablation1 trial

Chemoradiotherapy1 trial

Solid Tumors1 trial

Gastric or Gastroesophageal Junction Adenocarcinoma1 trial

Triple Negative Breast Cancer (TNBC)1 trial

Triple-Negative Breast Cancer1 trial

Extensive-stage Small-cell Lung Cancer1 trial

Head and Neck Squamous Cell Carcinoma1 trial

Non-Small Cell Lung Cancer1 trial

References

Drug Info

Quick Facts

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