Last reviewed 2026-06-02 · How we verify

HRS-9057 injection set

Fujian Shengdi Pharmaceutical Co., Ltd. · Phase 2 active Small molecule ✓ Verified Jun 2026 Quality 0/100

HRS-9057 injection set is a Small molecule drug developed by Fujian Shengdi Pharmaceutical Co., Ltd.. It is currently in Phase 2 development.

HRS-9057 injection set is being studied in a Phase II clinical trial for the treatment of fluid retention caused by heart failure. The trial is comparing the efficacy of HRS-9057 injection set to 5% glucose injection and 0.9% sodium chloride injection.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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-9057 injection set
Sponsor	Fujian Shengdi Pharmaceutical Co., Ltd.
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Phase II Clinical Study of HRS-9057 Injection in Patients With Heart Failure-induced Fluid Retention (PHASE2)

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-9057 injection set CI brief — competitive landscape report
HRS-9057 injection set updates RSS · CI watch RSS
Fujian Shengdi Pharmaceutical Co., Ltd. portfolio CI

Frequently asked questions about HRS-9057 injection set

What is HRS-9057 injection set?

HRS-9057 injection set is a Small molecule drug developed by Fujian Shengdi Pharmaceutical Co., Ltd..

Who makes HRS-9057 injection set?

HRS-9057 injection set is developed by Fujian Shengdi Pharmaceutical Co., Ltd. (see full Fujian Shengdi Pharmaceutical Co., Ltd. pipeline at /company/fujian-shengdi-pharmaceutical-co-ltd).

What development phase is HRS-9057 injection set in?

HRS-9057 injection set is in Phase 2.

Manufacturer: Fujian Shengdi Pharmaceutical Co., Ltd. — full pipeline

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