Last reviewed 2026-06-02 · How we verify

SHR2554; SHR-A2102

Jiangsu HengRui Medicine Co., Ltd. · Phase 2 active Small molecule ✓ Verified Jun 2026

SHR2554; SHR-A2102 is a Small molecule drug developed by Jiangsu HengRui Medicine Co., Ltd.. It is currently in Phase 2 development.

SHR2554 is a treatment being studied in a Phase II clinical trial for locally advanced or metastatic non-small cell lung cancer. The exact mechanism of SHR2554 is unknown, but it is also known as an IL-15 superagonist, similar to SHR1501.

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	SHR2554; SHR-A2102
Sponsor	Jiangsu HengRui Medicine 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 SHR2554 Tablets Combined With Other Anti-tumor Treatments in Non-small Cell Lung Cancer Subjects (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:

SHR2554; SHR-A2102 CI brief — competitive landscape report
SHR2554; SHR-A2102 updates RSS · CI watch RSS
Jiangsu HengRui Medicine Co., Ltd. portfolio CI

Frequently asked questions about SHR2554; SHR-A2102

What is SHR2554; SHR-A2102?

SHR2554; SHR-A2102 is a Small molecule drug developed by Jiangsu HengRui Medicine Co., Ltd..

Who makes SHR2554; SHR-A2102?

SHR2554; SHR-A2102 is developed by Jiangsu HengRui Medicine Co., Ltd. (see full Jiangsu HengRui Medicine Co., Ltd. pipeline at /company/jiangsu-hengrui-medicine-co-ltd).

What development phase is SHR2554; SHR-A2102 in?

SHR2554; SHR-A2102 is in Phase 2.

Manufacturer: Jiangsu HengRui Medicine Co., Ltd. — full pipeline

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