Last reviewed 2026-05-22 · How we verify

APL-1202 in combination with Epirubicin

Jiangsu Yahong Meditech Co., Ltd aka Asieris · Phase 3 active Small molecule ✓ Verified May 2026 Quality 0/100

APL-1202 in combination with Epirubicin is a Small molecule drug developed by Jiangsu Yahong Meditech Co., Ltd aka Asieris. It is currently in Phase 3 development.

APL-1202 is a small molecule being studied in combination with Epirubicin for the treatment of Non-muscle Invasive Bladder Cancer. The combination of APL-1202 and Epirubicin is being investigated for its safety and efficacy in patients with intermediate and high-risk chemo-refractory Non-muscle Invasive Bladder Cancer.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	APL-1202 in combination with Epirubicin
Sponsor	Jiangsu Yahong Meditech Co., Ltd aka Asieris
Modality	Small molecule
Phase	Phase 3

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Safety and Efficacy of APL-1202 in Combination With Epirubicin Hydrochloride Versus Epirubicin Hydrochloride Alone in Intermediate and High-risk Chemo-refractory Non-muscle Invasive Bladder Cancer (NMIBC) Patients (PHASE3)

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:

APL-1202 in combination with Epirubicin CI brief — competitive landscape report
APL-1202 in combination with Epirubicin updates RSS · CI watch RSS
Jiangsu Yahong Meditech Co., Ltd aka Asieris portfolio CI

Frequently asked questions about APL-1202 in combination with Epirubicin

What is APL-1202 in combination with Epirubicin?

APL-1202 in combination with Epirubicin is a Small molecule drug developed by Jiangsu Yahong Meditech Co., Ltd aka Asieris.

Who makes APL-1202 in combination with Epirubicin?

APL-1202 in combination with Epirubicin is developed by Jiangsu Yahong Meditech Co., Ltd aka Asieris (see full Jiangsu Yahong Meditech Co., Ltd aka Asieris pipeline at /company/jiangsu-yahong-meditech-co-ltd-aka-asieris).

What development phase is APL-1202 in combination with Epirubicin in?

APL-1202 in combination with Epirubicin is in Phase 3.

Manufacturer: Jiangsu Yahong Meditech Co., Ltd aka Asieris — full pipeline

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