Last reviewed 2026-05-14 · How we verify

HRS-6257

Shanghai Hengrui Pharmaceutical Co., Ltd. · Phase 1 active Small molecule

HRS-6257 is a Small molecule drug developed by Shanghai Hengrui Pharmaceutical Co., Ltd.. It is currently in Phase 1 development.

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-6257
Sponsor	Shanghai Hengrui Pharmaceutical 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 Study of Single and Multiple Doses of HRS-6257 in Healthy Subjects (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-6257 CI brief — competitive landscape report
HRS-6257 updates RSS · CI watch RSS
Shanghai Hengrui Pharmaceutical Co., Ltd. portfolio CI

Frequently asked questions about HRS-6257

What is HRS-6257?

HRS-6257 is a Small molecule drug developed by Shanghai Hengrui Pharmaceutical Co., Ltd..

Who makes HRS-6257?

HRS-6257 is developed by Shanghai Hengrui Pharmaceutical Co., Ltd. (see full Shanghai Hengrui Pharmaceutical Co., Ltd. pipeline at /company/shanghai-hengrui-pharmaceutical-co-ltd).

What development phase is HRS-6257 in?

HRS-6257 is in Phase 1.

Manufacturer: Shanghai Hengrui Pharmaceutical Co., Ltd. — full pipeline

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