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TQB3616 capsules
TQB3616 capsules is a FGFR inhibitor Small molecule drug developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. It is currently in Phase 3 development for Advanced or metastatic solid tumors with FGFR alterations (in development).
TQB3616 is a small-molecule inhibitor that targets fibroblast growth factor receptor (FGFR) signaling pathways.
TQB3616 capsules are a small molecule intervention being studied in clinical trials for various conditions, including breast cancer, advanced lung carcinoma, and digestive system tumors. The exact mechanism of TQB3616 capsules is not specified in the provided information, but they are being investigated in combination with other treatments such as fulvestrant injection and hormone receptor-positive therapies.
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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 | TQB3616 capsules |
|---|---|
| Sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
| Drug class | FGFR inhibitor |
| Target | FGFR (Fibroblast Growth Factor Receptor) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
TQB3616 selectively inhibits FGFR tyrosine kinases, which are frequently dysregulated in various cancers through gene amplification, mutation, or translocation. By blocking FGFR-mediated signaling, the drug suppresses tumor cell proliferation and survival in FGFR-dependent malignancies. This mechanism is particularly relevant in cancers with FGFR alterations, including certain lung, gastric, and other solid tumors.
Approved indications
- Advanced or metastatic solid tumors with FGFR alterations (in development)
Common side effects
- Hyperphosphatemia
- Diarrhea
- Fatigue
- Nausea
- Stomatitis
Key clinical trials
- To Evaluate the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated Hormone-receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer (PHASE3)
- Clinical Trial of Evaluating TQB3912 Tablets Combined With Fulvestrant Injection±TQB3616 Capsules for Locally Advanced or Metastatic Hormone Receptor(HR)-Positive and Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer (PHASE1, PHASE2)
- TQB3616 Capsules in the Treatment of Dedifferentiated Liposarcoma (PHASE2)
- Evaluation of TQB3616 Capsules in a Phase II Clinical Trial for Recurrent/Metastatic Breast Cancer (PHASE2)
- Drug-Drug Interaction (DDI) Study for TQB3616 (PHASE1)
- TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer in Clinical Trail (PHASE3)
- A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent/Metastatic Breast Cancer (PHASE1, PHASE2)
- Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer (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:
- TQB3616 capsules CI brief — competitive landscape report
- TQB3616 capsules updates RSS · CI watch RSS
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd. portfolio CI
Frequently asked questions about TQB3616 capsules
What is TQB3616 capsules?
How does TQB3616 capsules work?
What is TQB3616 capsules used for?
Who makes TQB3616 capsules?
What drug class is TQB3616 capsules in?
What development phase is TQB3616 capsules in?
What are the side effects of TQB3616 capsules?
What does TQB3616 capsules target?
Related
- Drug class: All FGFR inhibitor drugs
- Target: All drugs targeting FGFR (Fibroblast Growth Factor Receptor)
- Manufacturer: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced or metastatic solid tumors with FGFR alterations (in development)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing