Last reviewed 2026-04-23 · How we verify

HL140 5/10

Hanlim Pharm. Co., Ltd. · Phase 3 active Small molecule

HL140 5/10 is a PD-1/PD-L1 inhibitor Small molecule drug developed by Hanlim Pharm. Co., Ltd.. It is currently in Phase 3 development for Non-small cell lung cancer, PD-L1 positive.

HL140 5/10 is a small molecule that targets the PD-1/PD-L1 pathway.

HL140 5/10 is a small molecule that targets the PD-1/PD-L1 pathway. Used for Non-small cell lung cancer, PD-L1 positive.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	HL140 5/10
Sponsor	Hanlim Pharm. Co., Ltd.
Drug class	PD-1/PD-L1 inhibitor
Target	PD-1
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

By binding to PD-1, HL140 5/10 prevents its interaction with PD-L1, thereby enhancing T-cell activation and proliferation. This leads to an anti-tumor immune response.

Approved indications

Non-small cell lung cancer, PD-L1 positive

Common side effects

Pneumonitis
Hypothyroidism

Key clinical trials

Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary Hypercholesterolemia (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:

HL140 5/10 CI brief — competitive landscape report
HL140 5/10 updates RSS · CI watch RSS
Hanlim Pharm. Co., Ltd. portfolio CI

Frequently asked questions about HL140 5/10

What is HL140 5/10?

HL140 5/10 is a PD-1/PD-L1 inhibitor drug developed by Hanlim Pharm. Co., Ltd., indicated for Non-small cell lung cancer, PD-L1 positive.

How does HL140 5/10 work?

HL140 5/10 is a small molecule that targets the PD-1/PD-L1 pathway.

What is HL140 5/10 used for?

HL140 5/10 is indicated for Non-small cell lung cancer, PD-L1 positive.

Who makes HL140 5/10?

HL140 5/10 is developed by Hanlim Pharm. Co., Ltd. (see full Hanlim Pharm. Co., Ltd. pipeline at /company/hanlim-pharm-co-ltd).

What drug class is HL140 5/10 in?

HL140 5/10 belongs to the PD-1/PD-L1 inhibitor class. See all PD-1/PD-L1 inhibitor drugs at /class/pd-1-pd-l1-inhibitor.

What development phase is HL140 5/10 in?

HL140 5/10 is in Phase 3.

What are the side effects of HL140 5/10?

Common side effects of HL140 5/10 include Pneumonitis, Hypothyroidism.

What does HL140 5/10 target?

HL140 5/10 targets PD-1 and is a PD-1/PD-L1 inhibitor.

Drug class: All PD-1/PD-L1 inhibitor drugs
Target: All drugs targeting PD-1
Manufacturer: Hanlim Pharm. Co., Ltd. — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Non-small cell lung cancer, PD-L1 positive

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing