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Neoadjuvant immunochemotherapy
Neoadjuvant immunochemotherapy is a Small molecule drug developed by Henan Cancer Hospital. It is currently in Phase 3 development for Resectable or locally advanced solid tumors (specific tumor type not specified in available data). Also known as: Neoadjuvant immunotherapy, surgery.
Neoadjuvant immunochemotherapy combines chemotherapy with immunotherapy agents to enhance anti-tumor immune responses before surgical resection.
Neoadjuvant immunochemotherapy combines chemotherapy with immunotherapy agents to enhance anti-tumor immune responses before surgical resection. Used for Resectable or locally advanced solid tumors (specific tumor type not specified in available data).
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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.
| 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 | Neoadjuvant immunochemotherapy |
|---|---|
| Also known as | Neoadjuvant immunotherapy, surgery |
| Sponsor | Henan Cancer Hospital |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This treatment approach uses chemotherapy to reduce tumor burden and promote immunogenic cell death, while simultaneously activating the immune system through checkpoint inhibitors or other immunotherapeutic agents. Administered before surgery (neoadjuvant setting), it aims to improve pathological complete response rates and enhance long-term survival by priming anti-tumor immunity before definitive surgical intervention.
Approved indications
- Resectable or locally advanced solid tumors (specific tumor type not specified in available data)
Common side effects
- Chemotherapy-related myelosuppression
- Immune-related adverse events (fatigue, rash, pneumonitis)
- Gastrointestinal toxicity
- Cardiac toxicity
Key clinical trials
- Development and Multicenter Validation of a Novel Bio-Anatomical Staging System for Predicting Survival and Tailoring Adjuvant Therapy in ESCC After Neoadjuvant Chemoimmunotherapy.
- Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma (PHASE2)
- Impact of Postoperative Radiotherapy Versus PD-1 Inhibitor Maintenance on Survival in Resectable Locally Advanced Oral and Oropharyngeal Squamous Cell Carcinoma
- Time-of-Day of Immunotherapy Infusion in Neoadjuvant Immunochemotherapy for Thoracic ESCC (PHASE2)
- Efficacy and Survival Analysis of Perioperative Treatment of Locally Advanced Gastric or Gastroesophageal Junction Cancer
- Adjuvant Chemotherapy +/- Cemiplimab and Sequential Hypofractionated Radiotherapy in Unfit or Elderly Patients With Stage III Lung Cancer (PHASE2)
- Neoadjuvant Immunochemotherapy and Chemoradiotherapy Followed by Surgery for Advanced Esophageal Squamous Cell Carcinoma (PHASE2)
- Hypofractionated Radiotherapy Plus Immunochemotherapy for Neoadjuvant Treatment of Gastroesophageal Junction Adenocarcinoma (PHASE1, PHASE2)
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:
- Neoadjuvant immunochemotherapy CI brief — competitive landscape report
- Neoadjuvant immunochemotherapy updates RSS · CI watch RSS
- Henan Cancer Hospital portfolio CI
Frequently asked questions about Neoadjuvant immunochemotherapy
What is Neoadjuvant immunochemotherapy?
How does Neoadjuvant immunochemotherapy work?
What is Neoadjuvant immunochemotherapy used for?
Who makes Neoadjuvant immunochemotherapy?
Is Neoadjuvant immunochemotherapy also known as anything else?
What development phase is Neoadjuvant immunochemotherapy in?
What are the side effects of Neoadjuvant immunochemotherapy?
Related
- Manufacturer: Henan Cancer Hospital — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Resectable or locally advanced solid tumors (specific tumor type not specified in available data)
- Also known as: Neoadjuvant immunotherapy, surgery
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing