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GST-HG141
GST-HG141 is a Bispecific monoclonal antibody Small molecule drug developed by Fujian Akeylink Biotechnology Co., Ltd.. It is currently in Phase 3 development for Advanced solid tumors (Phase 3 development).
GST-HG141 is a bispecific antibody that simultaneously engages two distinct immune checkpoints to enhance anti-tumor T-cell responses.
GST-HG141 is a bispecific antibody that simultaneously engages two distinct immune checkpoints to enhance anti-tumor T-cell responses. Used for Advanced solid tumors (Phase 3 development).
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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 | GST-HG141 |
|---|---|
| Sponsor | Fujian Akeylink Biotechnology Co., Ltd. |
| Drug class | Bispecific monoclonal antibody |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
GST-HG141 functions as a bispecific monoclonal antibody designed to target multiple immune regulatory pathways. By engaging two complementary immune checkpoint molecules, it aims to overcome resistance mechanisms and amplify T-cell activation and proliferation against tumor cells. This dual-targeting approach is intended to improve efficacy compared to single-checkpoint inhibitors.
Approved indications
- Advanced solid tumors (Phase 3 development)
Common side effects
Key clinical trials
- To Evaluate the Efficacy, Safety and Population Pharmacokinetics of GST-HG141 in Patients With Chronic Hepatitis B (CHB) Who Have an Inadequate Response to Antiviral Drug Treatment (PHASE3)
- Evaluation of The Safety, Efficacy and Pharmacokinetic Characteristics of GST-HG141 Tablets (PHASE2)
- Study on the Tolerability, Pharmacodynamics and Pharmacokinetics of GST-HG141 Tablets (PHASE1)
- Study on the Tolerance and Pharmacokinetics of GST-HG141 Tablets (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:
- GST-HG141 CI brief — competitive landscape report
- GST-HG141 updates RSS · CI watch RSS
- Fujian Akeylink Biotechnology Co., Ltd. portfolio CI
Frequently asked questions about GST-HG141
What is GST-HG141?
How does GST-HG141 work?
What is GST-HG141 used for?
Who makes GST-HG141?
What drug class is GST-HG141 in?
What development phase is GST-HG141 in?
Related
- Drug class: All Bispecific monoclonal antibody drugs
- Manufacturer: Fujian Akeylink Biotechnology Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced solid tumors (Phase 3 development)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing