Floatz Rating
B62/100
Confidence
Indicative
Sponsor
RemeGen Co., Ltd.
Modality
Small molecule
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
64High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT05745740CT.gov A Study of RC48-ADC Combined With Pyrotinib For Treatment of Local Advanced or Metastasis NSCLC With HER2 Mutation | — | Unknown | — | — | — |
NCT06185400CT.gov RC48 Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations | — | Not Yet Recruiting | — | — | — |
NCT05482568CT.gov A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer | — | Recruiting | — | — | — |
NCT05751018CT.gov Phase II Clinical Study of Pyrotinib in First-line Treatment of Primary HER2-amplified/Mutated Advanced Non-small Cell Lung Cancer | — | Recruiting | — | — | — |
NCT04706949CT.gov Pyrotinib Combined With Pemetrexed Plus Carboplatin in the First-line Treatment | — | Unknown | — | — | — |
NCT04447118CT.gov Phase 3 Study of Pyrotinib Versus Docetaxel in Patients With Advanced Non-squamous NSCLC Harboring a HER2 Exon 20 Mutation Who Failed Platinum Based Chemotherapy | — | Completed | — | — | — |
NCT04382300CT.gov Pyrotinib Plus Thalidomide in Advanced NSCLC Patients Harboring HER2 Exon 20 Insertions | — | Unknown | — | — | — |
NCT04063462CT.gov Phase 2 Study of Pyrotinib in Previously Treated Patients With NSCLC Having EGFR or ERBB2 Exon 20 Insertion Mutation | — | Unknown | — | — | — |
NCT04144569CT.gov PD-1 Combined With Pyrotinib for Chemotherapy Failure HER2 Insertion Mutation Advanced NSCLC | — | Recruiting | — | — | — |
NCT02834936CT.gov A Clinica Study of Pyrotinib in Patients of Advanced Non-Small Cell Lung Cancer With HER2 Mutation | — | Completed | — | — | — |
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NCT02500199CT.gov Phase I Study of Pyrotinib in Patients With HER2-positive Solid Tumors | — | Unknown | — | — | — |
NCT02535507CT.gov Efficacy and Safety of Pyrotinib in Patients With HER2 Mutation Advanced Non-Small Cell Lung Cancer | — | Unknown | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
59High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Non-Small Cell Lung Carcinoma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Pyrotinib (this asset) | RemeGen Co., Ltd. | P3 | B · 62 |
| Necitumumab | Jonsson Comprehensive Cancer Center | P3 | BBB |
| Glumetinib | Shanghai JMT-Bio Inc. | P3 | BBB |
| Veliparib | AbbVie | P3 | BBB |
| d-0316 | Betta Pharmaceuticals Co., Ltd. | P2/3 | BBB |
| Icotinib | The First Affiliated Hospital of Guangzhou Medical University | P4 | BBB |
| Zoledronate | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | P4 | BBB |
| Onartuzumab | Hoffmann-La Roche | P3 | BBB |
| Avitinib | Hangzhou ACEA Pharmaceutical Research Co., Ltd. | P3 | BBB |
+42 more in the Non-Small Cell Lung Carcinoma cohort
Other indications for Pyrotinib
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Breast Carcinoma | — | P3 | BB · 70 |
| HER2 Positive Breast Carcinoma | — | P4 | BB · 66 |
| Invasive Breast Carcinoma | — | P3 | BB · 64 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Pyrotinib in Non-Small Cell Lung Carcinoma. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/pyrotinib-non-small-cell-lung-carcinoma
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