Last reviewed 2026-05-14 · How we verify

HN2302 Injection

The Affiliated Hospital of Xuzhou Medical University · Phase 1 active Small molecule Quality 3/100

HN2302 Injection is a Small molecule drug developed by The Affiliated Hospital of Xuzhou Medical University. It is currently in Phase 1 development. Also known as: in vivo CAR-T.

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	HN2302 Injection
Also known as	in vivo CAR-T
Sponsor	The Affiliated Hospital of Xuzhou Medical University
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Efficacy and Safety of HN2302 in Refractory Myasthenia Gravis(MG) (NA)

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:

HN2302 Injection CI brief — competitive landscape report
HN2302 Injection updates RSS · CI watch RSS
The Affiliated Hospital of Xuzhou Medical University portfolio CI

Frequently asked questions about HN2302 Injection

What is HN2302 Injection?

HN2302 Injection is a Small molecule drug developed by The Affiliated Hospital of Xuzhou Medical University.

Who makes HN2302 Injection?

HN2302 Injection is developed by The Affiliated Hospital of Xuzhou Medical University (see full The Affiliated Hospital of Xuzhou Medical University pipeline at /company/the-affiliated-hospital-of-xuzhou-medical-university).

Is HN2302 Injection also known as anything else?

HN2302 Injection is also known as in vivo CAR-T.

What development phase is HN2302 Injection in?

HN2302 Injection is in Phase 1.

Manufacturer: The Affiliated Hospital of Xuzhou Medical University — full pipeline
Also known as: in vivo CAR-T

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