Chidamide in combination with Ivonescimab

Guangdong Association of Clinical Trials · Phase 2 active Small molecule

Chidamide in combination with Ivonescimab is a Small molecule drug developed by Guangdong Association of Clinical Trials. It is currently in Phase 2 development. Also known as: Tucidinostat, CS055, AK112.

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	Chidamide in combination with Ivonescimab
Also known as	Tucidinostat, CS055, AK112
Sponsor	Guangdong Association of Clinical Trials
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• A Prospective, Single-Arm, Multicenter, Phase II Clinical Study of Chidamide Combined With Ivonescimab in the Treatment of Advanced Non-Small Cell Lung Cancer With Acquired Resistance to Immunotherapy and High YAP Protein Expression (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:

• Chidamide in combination with Ivonescimab CI brief — competitive landscape report
• Chidamide in combination with Ivonescimab updates RSS · CI watch RSS
• Guangdong Association of Clinical Trials portfolio CI

Frequently asked questions about Chidamide in combination with Ivonescimab

What is Chidamide in combination with Ivonescimab?

Chidamide in combination with Ivonescimab is a Small molecule drug developed by Guangdong Association of Clinical Trials.

Who makes Chidamide in combination with Ivonescimab?

Chidamide in combination with Ivonescimab is developed by Guangdong Association of Clinical Trials (see full Guangdong Association of Clinical Trials pipeline at /company/guangdong-association-of-clinical-trials).

Is Chidamide in combination with Ivonescimab also known as anything else?

Chidamide in combination with Ivonescimab is also known as Tucidinostat, CS055, AK112.

What development phase is Chidamide in combination with Ivonescimab in?

Chidamide in combination with Ivonescimab is in Phase 2.

Related

• Manufacturer: Guangdong Association of Clinical Trials — full pipeline
• Also known as: Tucidinostat, CS055, AK112