Last reviewed 2026-04-23 · How we verify

Hydronidone (270mg)

Beijing Continent Pharmaceutical Co, Ltd. · Phase 3 active Small molecule

Hydronidone (270mg) is a Corticosteroid Small molecule drug developed by Beijing Continent Pharmaceutical Co, Ltd.. It is currently in Phase 3 development for Inflammatory and autoimmune disorders (specific indication under phase 3 evaluation not publicly detailed).

Hydronidone is a corticosteroid that reduces inflammation and suppresses immune responses by binding to glucocorticoid receptors.

Hydronidone is a corticosteroid that reduces inflammation and suppresses immune responses by binding to glucocorticoid receptors. Used for Inflammatory and autoimmune disorders (specific indication under phase 3 evaluation not publicly detailed).

Likelihood of approval

59.3% 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).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.

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	Hydronidone (270mg)
Sponsor	Beijing Continent Pharmaceutical Co, Ltd.
Drug class	Corticosteroid
Target	Glucocorticoid receptor
Modality	Small molecule
Therapeutic area	Immunology/Rheumatology
Phase	Phase 3

Mechanism of action

As a synthetic corticosteroid, hydronidone exerts anti-inflammatory effects through glucocorticoid receptor activation, leading to decreased production of inflammatory cytokines and immune cell activation. It is used to manage inflammatory and autoimmune conditions where suppression of the immune response is therapeutically beneficial.

Approved indications

Inflammatory and autoimmune disorders (specific indication under phase 3 evaluation not publicly detailed)

Common side effects

Hyperglycemia
Hypertension
Osteoporosis
Immunosuppression/increased infection risk
Adrenal suppression

Key clinical trials

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:

Hydronidone (270mg) CI brief — competitive landscape report
Hydronidone (270mg) updates RSS · CI watch RSS
Beijing Continent Pharmaceutical Co, Ltd. portfolio CI

Frequently asked questions about Hydronidone (270mg)

What is Hydronidone (270mg)?

Hydronidone (270mg) is a Corticosteroid drug developed by Beijing Continent Pharmaceutical Co, Ltd., indicated for Inflammatory and autoimmune disorders (specific indication under phase 3 evaluation not publicly detailed).

How does Hydronidone (270mg) work?

Hydronidone is a corticosteroid that reduces inflammation and suppresses immune responses by binding to glucocorticoid receptors.

What is Hydronidone (270mg) used for?

Hydronidone (270mg) is indicated for Inflammatory and autoimmune disorders (specific indication under phase 3 evaluation not publicly detailed).

Who makes Hydronidone (270mg)?

Hydronidone (270mg) is developed by Beijing Continent Pharmaceutical Co, Ltd. (see full Beijing Continent Pharmaceutical Co, Ltd. pipeline at /company/beijing-continent-pharmaceutical-co-ltd).

What drug class is Hydronidone (270mg) in?

Hydronidone (270mg) belongs to the Corticosteroid class. See all Corticosteroid drugs at /class/corticosteroid.

What development phase is Hydronidone (270mg) in?

Hydronidone (270mg) is in Phase 3.

What are the side effects of Hydronidone (270mg)?

Common side effects of Hydronidone (270mg) include Hyperglycemia, Hypertension, Osteoporosis, Immunosuppression/increased infection risk, Adrenal suppression.

What does Hydronidone (270mg) target?

Hydronidone (270mg) targets Glucocorticoid receptor and is a Corticosteroid.

Drug class: All Corticosteroid drugs
Target: All drugs targeting Glucocorticoid receptor
Manufacturer: Beijing Continent Pharmaceutical Co, Ltd. — full pipeline
Therapeutic area: All drugs in Immunology/Rheumatology
Indication: Drugs for Inflammatory and autoimmune disorders (specific indication under phase 3 evaluation not publicly detailed)

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