HX008

Phase 3Small molecule

BBinhui Biopharmaceutical Co., Ltd.

HX008 is one of 235 small molecule programs targeting Metastatic Colorectal Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

234

Competitors

Pipeline

Status by Indication[3][1]

Indication

Metastatic Colorectal CancerActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

MelanomaActive, not recruiting

Hepatocellular CarcinomaActive, not recruiting

Bladder CancerActive, not recruiting

Gastric CancerActive, not recruiting

Thyroid CancerActive, not recruiting

Squamous Cell CarcinomaActive, not recruiting

Metastatic Colorectal CancerPhase 3

Active, not recruiting

Non-Small Cell Lung CancerPhase 2/Phase 3

Active, not recruiting

MelanomaPhase 3

Active, not recruiting

Hepatocellular CarcinomaPhase 2

Active, not recruiting

Bladder CancerPhase 2

Active, not recruiting

Gastric CancerPhase 3

Active, not recruiting

Thyroid CancerPhase 2

Active, not recruiting

Squamous Cell CarcinomaPhase 1

Active, not recruiting

Competition

Competitive Landscape

1639 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

HX008

BBinhui Biopharmaceutical Co., Ltd.

Phase 3

1 2

PORTRAZZA

Eli Lilly

Preclinical

8 3

Lenvima

Eisai

Preclinical

6 4

Imjudo

AstraZeneca

Preclinical

5 5

Vizimpro

Pfizer

Preclinical

4 6

Gilotrif

Boehringer Ingelheim

Preclinical

12 7

Ofev

Boehringer Ingelheim

Preclinical

7 8

Immunotherapy

Bristol-Myers Squibb

Preclinical

12 9

PD-1 Inhibitor

Johnson & Johnson

Preclinical

2 10

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—

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

Timeline

Expected Milestones

Q4 2028

Phase 3Not yet recruiting

Metastatic Colorectal Cancer

NCT05652894

Q3 2030

Phase 1Not yet recruiting

Squamous Cell Carcinoma

NCT07054307

Clinical

Trials by Indication[1]

Melanoma4 trials

A Study of HX008 Plus Transcatheter Arterial Chemoembolization (TACE) in the First-Line Treatment of Subjects With Stage IV (M1c) Melanoma That is Metastatic to the Liver

Unknown status·TTaizhou Hanzhong biomedical co. LTD·Phase 3·NCT05647954·350 enrolled

A Study of HX008 Plus LP002 for the Treatment of Patients With Advanced Melanoma

Unknown status·TTaizhou HoudeAoke Biomedical Co., Ltd.·Phase 1·NCT04756934·63 enrolled

A Study of HX008 for the Treatment of Patients With Malignant Melanoma

Unknown status·TTaizhou Hanzhong biomedical co. LTD·Phase 2·NCT04749485·119 enrolled

Show 1 more trial

OH2 Injection in Combination With HX008 for Melanoma.

Recruiting·BBinhui Biopharmaceutical Co., Ltd.·Phase 1/2·NCT04616443·60 enrolled

Patients With Advanced Solid Tumors1 trial

A Phase Ib Study of HX008 in Patients With Advanced Solid Tumors

Unknown status·TTaizhou Hanzhong biomedical co. LTD·Phase 1·NCT04825392·30 enrolled

Metastatic Colorectal Cancer1 trial

A Study of HX008 Compared to Chemotherapy in the First-Line Treatment of Subjects With MSI-H/dMMR Metastatic Colorectal Cancer

Not yet recruiting·TTaizhou Hanzhong biomedical co. LTD·Phase 3·NCT05652894·190 enrolled

Squamous Cell Carcinoma1 trial

MRG003 Plus HX008 as First-Line Treatment for EGFR-Positive Locally Advanced or Metastatic Penile Squamous Cell Carcinoma

Not yet recruiting·JJiyan Liu·Phase 1·NCT07054307·10 enrolled

Non-Small Cell Lung Cancer1 trial

HX008 Plus Chemotherapy VS Pembrolizumab Plus Chemotherapy As the First-line Treatment in Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer

Unknown status·TTaizhou Hanzhong biomedical co. LTD·Phase 2/3·NCT04750083·700 enrolled

4 more indications

Thyroid Cancer1 trial

Study of HX008 for the Treatment of Anaplastic Thyroid Cancer (ATC)

Unknown status·TTaizhou Hanzhong biomedical co. LTD·Phase 2·NCT04574817·66 enrolled

Hepatocellular Carcinoma1 trial

Study of HX008 in Combination With Bevacizumab or Lenvatinib for the Treatment of Advanced Hepatocellular Carcinoma (HCC)

Unknown status·TTaizhou Hanzhong biomedical co. LTD·Phase 2·NCT04741165·72 enrolled

Bladder Cancer1 trial

Study of HX008 for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer

Unknown status·TTaizhou Hanzhong biomedical co. LTD·Phase 2·NCT04738630·110 enrolled

Gastric Cancer1 trial

HX008 Plus Irinotecan Versus Placebo Plus Irinotecan as Second-line Treatment in Advanced Gastric Cancer

Unknown status·TTaizhou Hanzhong biomedical co. LTD·Phase 3·NCT04486651·560 enrolled

Sources

References

[1]
ClinicalTrials.gov — 12 trial records for HX008. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — HX008 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for HX008. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Binhui Biopharmaceutical 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: BBinhui Biopharmaceutical Co., Ltd.

HX008

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2028

Q3 2030

Trials by Indication[1]

Melanoma4 trials

Patients With Advanced Solid Tumors1 trial

Metastatic Colorectal Cancer1 trial

Squamous Cell Carcinoma1 trial

Non-Small Cell Lung Cancer1 trial

Thyroid Cancer1 trial

Hepatocellular Carcinoma1 trial

Bladder Cancer1 trial

Gastric Cancer1 trial

References

Drug Info

Quick Facts

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