Last reviewed 2026-04-23 · How we verify

Humia inj.

Huons Co., Ltd. · Phase 3 active Small molecule

Humia inj. is a Recombinant enzyme / Hyaluronidase Small molecule drug developed by Huons Co., Ltd.. It is currently in Phase 3 development for Adjuvant to enhance subcutaneous or intradermal administration of other drugs (phase 3 development).

Humia is a recombinant human hyaluronidase injection designed to enhance tissue permeability and facilitate drug distribution.

Humia is a recombinant human hyaluronidase injection designed to enhance tissue permeability and facilitate drug distribution. Used for Adjuvant to enhance subcutaneous or intradermal administration of other drugs (phase 3 development).

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	Humia inj.
Sponsor	Huons Co., Ltd.
Drug class	Recombinant enzyme / Hyaluronidase
Target	Hyaluronic acid (extracellular matrix component)
Modality	Small molecule
Therapeutic area	Oncology / General (adjuvant for drug delivery)
Phase	Phase 3

Mechanism of action

Humia works by enzymatically degrading hyaluronic acid in the extracellular matrix, temporarily increasing tissue permeability. This mechanism allows co-administered drugs to diffuse more effectively through tissues, improving bioavailability and therapeutic efficacy. It is used as an adjuvant to enhance the spread and absorption of other injectable medications.

Approved indications

Adjuvant to enhance subcutaneous or intradermal administration of other drugs (phase 3 development)

Common side effects

Local injection site reactions
Hypersensitivity reactions

Key clinical trials

A Study to Evaluate the Safety and Efficacy of Humia Inj. in Patients With Symptomatic Osteoarthritis of the Knee (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:

Humia inj. CI brief — competitive landscape report
Humia inj. updates RSS · CI watch RSS
Huons Co., Ltd. portfolio CI

Frequently asked questions about Humia inj.

What is Humia inj.?

Humia inj. is a Recombinant enzyme / Hyaluronidase drug developed by Huons Co., Ltd., indicated for Adjuvant to enhance subcutaneous or intradermal administration of other drugs (phase 3 development).

How does Humia inj. work?

Humia is a recombinant human hyaluronidase injection designed to enhance tissue permeability and facilitate drug distribution.

What is Humia inj. used for?

Humia inj. is indicated for Adjuvant to enhance subcutaneous or intradermal administration of other drugs (phase 3 development).

Who makes Humia inj.?

Humia inj. is developed by Huons Co., Ltd. (see full Huons Co., Ltd. pipeline at /company/huons-co-ltd).

What drug class is Humia inj. in?

Humia inj. belongs to the Recombinant enzyme / Hyaluronidase class. See all Recombinant enzyme / Hyaluronidase drugs at /class/recombinant-enzyme-hyaluronidase.

What development phase is Humia inj. in?

Humia inj. is in Phase 3.

What are the side effects of Humia inj.?

Common side effects of Humia inj. include Local injection site reactions, Hypersensitivity reactions.

What does Humia inj. target?

Humia inj. targets Hyaluronic acid (extracellular matrix component) and is a Recombinant enzyme / Hyaluronidase.

Drug class: All Recombinant enzyme / Hyaluronidase drugs
Target: All drugs targeting Hyaluronic acid (extracellular matrix component)
Manufacturer: Huons Co., Ltd. — full pipeline
Therapeutic area: All drugs in Oncology / General (adjuvant for drug delivery)
Indication: Drugs for Adjuvant to enhance subcutaneous or intradermal administration of other drugs (phase 3 development)

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