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HER2Bi-Armed T Cells
HER2Bi-Armed T Cells is a Small molecule drug developed by Yi Miao. It is currently in Phase 1 development. Also known as: HER2Bi-Armed ATCs.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | HER2Bi-Armed T Cells |
|---|---|
| Also known as | HER2Bi-Armed ATCs |
| Sponsor | Yi Miao |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Fatigue
- Chills
- Nausea
- Headache
- Back pain
- General disorders and administration site conditions - Other, specify
- Vomiting
- Hypertension
- Pain in extremity
- Arthritis
- Cardiac disorders - Other, specify
- Cholesterol high
Key clinical trials
- Her2-BATS and Pembrolizumab in Metastatic Breast Cancer (PHASE1, PHASE2)
- Pembro and HER2Bi-Armed Activated T Cells in Treating Patients With Metastatic Castration Resistant Prostate Cancer (PHASE2)
- Targeted T Cells After Neoadjuvant Chemotherapy in Treating Women With Stage II or III Breast Cancer Undergoing Surgery (PHASE2)
- Laboratory-Treated T Cells After Second-Line Chemotherapy in Treating Patients With HER2/Neu-Negative Metastatic Breast Cancer (PHASE2)
- BATs in Patients With Breast Cancer and Leptomeningeal Metastases (PHASE1)
- Activated T-cell Therapy, Low-Dose Aldesleukin, and Sargramostim in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer That is Stage III-IV, Refractory, or Recurrent (PHASE1)
- T Cell Mediated Adaptive Therapy for Her2-positive Neoplasms of Digestive System (PHASE1)
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:
- HER2Bi-Armed T Cells CI brief — competitive landscape report
- HER2Bi-Armed T Cells updates RSS · CI watch RSS
- Yi Miao portfolio CI
Frequently asked questions about HER2Bi-Armed T Cells
What is HER2Bi-Armed T Cells?
Who makes HER2Bi-Armed T Cells?
Is HER2Bi-Armed T Cells also known as anything else?
What development phase is HER2Bi-Armed T Cells in?
What are the side effects of HER2Bi-Armed T Cells?
Related
- Manufacturer: Yi Miao — full pipeline
- Also known as: HER2Bi-Armed ATCs
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing