Last reviewed 2026-06-02 · How we verify

HRS-7085 simulant

Shandong Suncadia Medicine Co., Ltd. · Phase 1 active Small molecule ✓ Verified Jun 2026

HRS-7085 simulant is a Small molecule drug developed by Shandong Suncadia Medicine Co., Ltd.. It is currently in Phase 1 development.

HRS-7085 is a small molecule simulant being studied in a clinical trial for Inflammatory Bowel Disease. The trial is investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of HRS-7085 tablets.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	HRS-7085 simulant
Sponsor	Shandong Suncadia Medicine Co., Ltd.
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Phase I Clinical Trial Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Oral Doses of HRS-7085 Tablets in Healthy Subjects, With Assessment of Food Effects (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:

HRS-7085 simulant CI brief — competitive landscape report
HRS-7085 simulant updates RSS · CI watch RSS
Shandong Suncadia Medicine Co., Ltd. portfolio CI

Frequently asked questions about HRS-7085 simulant

What is HRS-7085 simulant?

HRS-7085 simulant is a Small molecule drug developed by Shandong Suncadia Medicine Co., Ltd..

Who makes HRS-7085 simulant?

HRS-7085 simulant is developed by Shandong Suncadia Medicine Co., Ltd. (see full Shandong Suncadia Medicine Co., Ltd. pipeline at /company/shandong-suncadia-medicine-co-ltd).

What development phase is HRS-7085 simulant in?

HRS-7085 simulant is in Phase 1.

Manufacturer: Shandong Suncadia Medicine Co., Ltd. — full pipeline

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