Last reviewed 2026-05-27 · How we verify

ZSP0678-240mg

Guangdong Raynovent Biotech Co., Ltd · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

ZSP0678-240mg is a Small molecule drug developed by Guangdong Raynovent Biotech Co., Ltd. It is currently in Phase 1 development.

ZSP0678 is being studied in a Phase 1 clinical trial for its safety, tolerability, and pharmacokinetics in Chinese healthy adults, with doses of 10mg, 30mg, and 60mg being evaluated. Additionally, ZSP0678 is being investigated for its potential treatment of Nonalcoholic Steatohepatitis in a separate clinical trial.

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	ZSP0678-240mg
Sponsor	Guangdong Raynovent Biotech 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

Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP0678, and the Effect of Food on ZSP0678 Pharmacokinetics (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:

ZSP0678-240mg CI brief — competitive landscape report
ZSP0678-240mg updates RSS · CI watch RSS
Guangdong Raynovent Biotech Co., Ltd portfolio CI

Frequently asked questions about ZSP0678-240mg

What is ZSP0678-240mg?

ZSP0678-240mg is a Small molecule drug developed by Guangdong Raynovent Biotech Co., Ltd.

Who makes ZSP0678-240mg?

ZSP0678-240mg is developed by Guangdong Raynovent Biotech Co., Ltd (see full Guangdong Raynovent Biotech Co., Ltd pipeline at /company/guangdong-raynovent-biotech-co-ltd).

What development phase is ZSP0678-240mg in?

ZSP0678-240mg is in Phase 1.

Manufacturer: Guangdong Raynovent Biotech Co., Ltd — full pipeline

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