Last reviewed 2026-05-31 · How we verify

M701 pleural infusion

Wuhan YZY Biopharma Co., Ltd. · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

M701 pleural infusion is a Small molecule drug developed by Wuhan YZY Biopharma Co., Ltd.. It is currently in Phase 1 development.

M701 is a small molecule pleural infusion used to treat malignant pleural effusions caused by non-small cell lung cancer (NSCLC) Stage IV. It is administered via pleural infusion, a method of delivering medication directly into the pleural space surrounding the lungs.

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	M701 pleural infusion
Sponsor	Wuhan YZY Biopharma 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 Phase Ib/II Clinical Trial of M701 in the Treatment of Malignant Pleural Effusions Caused by NSCLC (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:

M701 pleural infusion CI brief — competitive landscape report
M701 pleural infusion updates RSS · CI watch RSS
Wuhan YZY Biopharma Co., Ltd. portfolio CI

Frequently asked questions about M701 pleural infusion

What is M701 pleural infusion?

M701 pleural infusion is a Small molecule drug developed by Wuhan YZY Biopharma Co., Ltd..

Who makes M701 pleural infusion?

M701 pleural infusion is developed by Wuhan YZY Biopharma Co., Ltd. (see full Wuhan YZY Biopharma Co., Ltd. pipeline at /company/wuhan-yzy-biopharma-co-ltd).

What development phase is M701 pleural infusion in?

M701 pleural infusion is in Phase 1.

Manufacturer: Wuhan YZY Biopharma Co., Ltd. — full pipeline

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