Last reviewed 2026-04-23 · How we verify

HX008 + TACE

Taizhou Hanzhong biomedical co. LTD · Phase 3 active Small molecule

HX008 + TACE is a PD-1 inhibitor Small molecule drug developed by Taizhou Hanzhong biomedical co. LTD. It is currently in Phase 3 development for Hepatocellular carcinoma (HCC) in combination with transarterial chemoembolization.

HX008 is a PD-1 inhibitor combined with TACE (transarterial chemoembolization) to enhance anti-tumor immunity while delivering localized chemotherapy to hepatic tumors.

HX008 is a PD-1 inhibitor combined with TACE (transarterial chemoembolization) to enhance anti-tumor immunity while delivering localized chemotherapy to hepatic tumors. Used for Hepatocellular carcinoma (HCC) in combination with transarterial chemoembolization.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	HX008 + TACE
Sponsor	Taizhou Hanzhong biomedical co. LTD
Drug class	PD-1 inhibitor
Target	PD-1
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

HX008, a humanized PD-1 monoclonal antibody, blocks the PD-1/PD-L1 checkpoint to reinvigorate T-cell-mediated anti-tumor immunity. When combined with TACE—a minimally invasive procedure that delivers chemotherapy directly to liver tumors while occluding their blood supply—the approach aims to synergize local tumor destruction with systemic immune activation, potentially improving outcomes in hepatocellular carcinoma.

Approved indications

Hepatocellular carcinoma (HCC) in combination with transarterial chemoembolization

Common side effects

Immune-related adverse events (irAEs)
Hepatotoxicity
Fatigue
Nausea

Key clinical 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 (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

HX008 + TACE CI brief — competitive landscape report
HX008 + TACE updates RSS · CI watch RSS
Taizhou Hanzhong biomedical co. LTD portfolio CI

Frequently asked questions about HX008 + TACE

What is HX008 + TACE?

HX008 + TACE is a PD-1 inhibitor drug developed by Taizhou Hanzhong biomedical co. LTD, indicated for Hepatocellular carcinoma (HCC) in combination with transarterial chemoembolization.

How does HX008 + TACE work?

HX008 is a PD-1 inhibitor combined with TACE (transarterial chemoembolization) to enhance anti-tumor immunity while delivering localized chemotherapy to hepatic tumors.

What is HX008 + TACE used for?

HX008 + TACE is indicated for Hepatocellular carcinoma (HCC) in combination with transarterial chemoembolization.

Who makes HX008 + TACE?

HX008 + TACE is developed by Taizhou Hanzhong biomedical co. LTD (see full Taizhou Hanzhong biomedical co. LTD pipeline at /company/taizhou-hanzhong-biomedical-co-ltd).

What drug class is HX008 + TACE in?

HX008 + TACE belongs to the PD-1 inhibitor class. See all PD-1 inhibitor drugs at /class/pd-1-inhibitor.

What development phase is HX008 + TACE in?

HX008 + TACE is in Phase 3.

What are the side effects of HX008 + TACE?

Common side effects of HX008 + TACE include Immune-related adverse events (irAEs), Hepatotoxicity, Fatigue, Nausea.

What does HX008 + TACE target?

HX008 + TACE targets PD-1 and is a PD-1 inhibitor.

Drug class: All PD-1 inhibitor drugs
Target: All drugs targeting PD-1
Manufacturer: Taizhou Hanzhong biomedical co. LTD — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Hepatocellular carcinoma (HCC) in combination with transarterial chemoembolization

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing