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HL036 Ophthalmic Solution
HL036 Ophthalmic Solution is a Biologic drug developed by HanAll BioPharma Co., Ltd.. It is currently in Phase 3 development for Dry eye disease or ocular surface disease (specific indication not publicly disclosed). Also known as: Tanfanercept.
HL036 is an ophthalmic solution designed to treat ocular surface disease, likely through anti-inflammatory or lubricating mechanisms.
HL036 is an ophthalmic solution designed to treat ocular surface disease, likely through anti-inflammatory or lubricating mechanisms. Used for Dry eye disease or ocular surface disease (specific indication not publicly disclosed).
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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).
| 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 | HL036 Ophthalmic Solution |
|---|---|
| Also known as | Tanfanercept |
| Sponsor | HanAll BioPharma Co., Ltd. |
| Modality | Biologic |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
HL036 is a topical eye drop formulation in Phase 3 development by HanAll BioPharma. Without disclosed mechanism details, the drug appears to target ocular surface conditions, potentially through anti-inflammatory signaling, mucin secretion enhancement, or tear film stabilization. The ophthalmic solution format indicates local delivery to the eye surface.
Approved indications
- Dry eye disease or ocular surface disease (specific indication not publicly disclosed)
Common side effects
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of Tanfanercept (HL036) in Dry Eye Disease (PHASE3)
- A Study to Assess Efficacy of HL036 in Subjects With Dry Eyes (PHASE2)
- A Study to Assess the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution in Participants With Dry Eye (PHASE3)
- A Study Evaluating HBM9036 Efficacy and Safety on Moderate to Severe Dry Eye (PHASE3)
- A Study to Assess Efficacy and Safety of HL036 in Subjects With Dry Eyes (PHASE3)
- Phase 1 Study for Safety and Tolerability of HL036 (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:
- HL036 Ophthalmic Solution CI brief — competitive landscape report
- HL036 Ophthalmic Solution updates RSS · CI watch RSS
- HanAll BioPharma Co., Ltd. portfolio CI
Frequently asked questions about HL036 Ophthalmic Solution
What is HL036 Ophthalmic Solution?
How does HL036 Ophthalmic Solution work?
What is HL036 Ophthalmic Solution used for?
Who makes HL036 Ophthalmic Solution?
Is HL036 Ophthalmic Solution also known as anything else?
What development phase is HL036 Ophthalmic Solution in?
Related
- Manufacturer: HanAll BioPharma Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Dry eye disease or ocular surface disease (specific indication not publicly disclosed)
- Also known as: Tanfanercept
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing