Last reviewed 2026-06-01 · How we verify

HS-10542 High Dose

Jiangsu Hansoh Pharmaceutical Co., Ltd. · Phase 2 active Small molecule ✓ Verified Jun 2026

HS-10542 High Dose is a Small molecule drug developed by Jiangsu Hansoh Pharmaceutical Co., Ltd.. It is currently in Phase 2 development.

HS-10542 High Dose is a small molecule being studied as a potential treatment for IgAN, Immunoglobulin A Nephropathy, Glomerular Disease, and Paroxysmal Nocturnal Hemoglobinuria in a Phase 2 clinical trial. The study is a randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of HS-10542 Capsules.

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	HS-10542 High Dose
Sponsor	Jiangsu Hansoh 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

Efficacy and Safety Study of HS-10542 for IgA Nephropathy (PHASE2)
Study of Safety and Efficacy of HS-10542 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PHASE1, 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:

HS-10542 High Dose CI brief — competitive landscape report
HS-10542 High Dose updates RSS · CI watch RSS
Jiangsu Hansoh Pharmaceutical Co., Ltd. portfolio CI

Frequently asked questions about HS-10542 High Dose

What is HS-10542 High Dose?

HS-10542 High Dose is a Small molecule drug developed by Jiangsu Hansoh Pharmaceutical Co., Ltd..

Who makes HS-10542 High Dose?

HS-10542 High Dose is developed by Jiangsu Hansoh Pharmaceutical Co., Ltd. (see full Jiangsu Hansoh Pharmaceutical Co., Ltd. pipeline at /company/jiangsu-hansoh-pharmaceutical-co-ltd).

What development phase is HS-10542 High Dose in?

HS-10542 High Dose is in Phase 2.

Manufacturer: Jiangsu Hansoh Pharmaceutical Co., Ltd. — full pipeline

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