Last reviewed 2026-06-02 · How we verify

Pure chemotherapy（Xelox）

The First People's Hospital of Hefei · Phase 3 active Small molecule Under review

Pure chemotherapy（Xelox） is a Chemotherapy combination regimen Small molecule drug developed by The First People's Hospital of Hefei. It is currently in Phase 3 development for Metastatic colorectal cancer, Gastric cancer, Breast cancer (adjuvant and metastatic settings). Also known as: CapeOX.

Xelox is a chemotherapy regimen combining capecitabine and oxaliplatin that inhibits DNA synthesis and causes DNA cross-linking to kill rapidly dividing cancer cells.

Pure chemotherapy, also known as Xelox, is a small molecule modality used to treat Colorectal Neoplasms. It is a combination of two anti-angiogenesis drugs, Endostar and Thalidomide, with chemotherapy.

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	Pure chemotherapy（Xelox）
Also known as	CapeOX
Sponsor	The First People's Hospital of Hefei
Drug class	Chemotherapy combination regimen
Target	Thymidylate synthase (capecitabine/5-FU); DNA (oxaliplatin)
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

Capecitabine is a fluoropyrimidine carbamate that is converted to 5-fluorouracil (5-FU), which inhibits thymidylate synthase and disrupts nucleotide synthesis. Oxaliplatin is a platinum-based agent that forms DNA adducts and cross-links, preventing DNA replication and transcription. Together, these agents provide synergistic cytotoxic effects against cancer cells.

Approved indications

Metastatic colorectal cancer
Gastric cancer
Breast cancer (adjuvant and metastatic settings)

Common side effects

Neutropenia
Diarrhea
Nausea/vomiting
Hand-foot syndrome
Peripheral neuropathy
Anemia
Thrombocytopenia

Key clinical trials

Application of Two Anti-angiogenesis Drugs Combined With Chemotherapy in Advanced Colorectal Cancer Under the Background of Precision Medical (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:

Pure chemotherapy（Xelox） CI brief — competitive landscape report
Pure chemotherapy（Xelox） updates RSS · CI watch RSS
The First People's Hospital of Hefei portfolio CI

Frequently asked questions about Pure chemotherapy（Xelox）

What is Pure chemotherapy（Xelox）?

Pure chemotherapy（Xelox） is a Chemotherapy combination regimen drug developed by The First People's Hospital of Hefei, indicated for Metastatic colorectal cancer, Gastric cancer, Breast cancer (adjuvant and metastatic settings).

How does Pure chemotherapy（Xelox） work?

Xelox is a chemotherapy regimen combining capecitabine and oxaliplatin that inhibits DNA synthesis and causes DNA cross-linking to kill rapidly dividing cancer cells.

What is Pure chemotherapy（Xelox） used for?

Pure chemotherapy（Xelox） is indicated for Metastatic colorectal cancer, Gastric cancer, Breast cancer (adjuvant and metastatic settings).

Who makes Pure chemotherapy（Xelox）?

Pure chemotherapy（Xelox） is developed by The First People's Hospital of Hefei (see full The First People's Hospital of Hefei pipeline at /company/the-first-people-s-hospital-of-hefei).

Is Pure chemotherapy（Xelox） also known as anything else?

Pure chemotherapy（Xelox） is also known as CapeOX.

What drug class is Pure chemotherapy（Xelox） in?

Pure chemotherapy（Xelox） belongs to the Chemotherapy combination regimen class. See all Chemotherapy combination regimen drugs at /class/chemotherapy-combination-regimen.

What development phase is Pure chemotherapy（Xelox） in?

Pure chemotherapy（Xelox） is in Phase 3.

What are the side effects of Pure chemotherapy（Xelox）?

Common side effects of Pure chemotherapy（Xelox） include Neutropenia, Diarrhea, Nausea/vomiting, Hand-foot syndrome, Peripheral neuropathy, Anemia.

What does Pure chemotherapy（Xelox） target?

Pure chemotherapy（Xelox） targets Thymidylate synthase (capecitabine/5-FU); DNA (oxaliplatin) and is a Chemotherapy combination regimen.

Drug class: All Chemotherapy combination regimen drugs
Target: All drugs targeting Thymidylate synthase (capecitabine/5-FU); DNA (oxaliplatin)
Manufacturer: The First People's Hospital of Hefei — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Metastatic colorectal cancer
Indication: Drugs for Gastric cancer
Indication: Drugs for Breast cancer (adjuvant and metastatic settings)
Also known as: CapeOX

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