Last reviewed 2026-05-23 · How we verify

targeted drug

Nanfang Hospital, Southern Medical University · Phase 3 active Small molecule Under review

targeted drug is a Tyrosine kinase inhibitor Small molecule drug developed by Nanfang Hospital, Southern Medical University. It is currently in Phase 3 development for Non-small cell lung cancer, EGFR mutation positive, Head and neck cancer, EGFR mutation positive.

This targeted drug works by binding to a specific protein on cancer cells, preventing them from growing and dividing.

Macimorelin is a small molecule used in research studies for conditions such as Growth Hormone Deficiency, Pain Threshold, and postoperative pain. It has been studied in combination with other interventions like Arginine and Clonidine in clinical trials.

Likelihood of approval

61.3% 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).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.

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	targeted drug
Sponsor	Nanfang Hospital, Southern Medical University
Drug class	Tyrosine kinase inhibitor
Target	EGFR
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

The drug specifically targets a protein that is overexpressed in certain types of cancer, leading to the inhibition of tumor growth and metastasis. This targeted approach aims to minimize harm to healthy cells while maximizing the impact on cancer cells.

Approved indications

Non-small cell lung cancer, EGFR mutation positive
Head and neck cancer, EGFR mutation positive

Common side effects

Rash
Diarrhea
Fatigue

Key clinical trials

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:

targeted drug CI brief — competitive landscape report
targeted drug updates RSS · CI watch RSS
Nanfang Hospital, Southern Medical University portfolio CI

Frequently asked questions about targeted drug

What is targeted drug?

targeted drug is a Tyrosine kinase inhibitor drug developed by Nanfang Hospital, Southern Medical University, indicated for Non-small cell lung cancer, EGFR mutation positive, Head and neck cancer, EGFR mutation positive.

How does targeted drug work?

This targeted drug works by binding to a specific protein on cancer cells, preventing them from growing and dividing.

What is targeted drug used for?

targeted drug is indicated for Non-small cell lung cancer, EGFR mutation positive, Head and neck cancer, EGFR mutation positive.

Who makes targeted drug?

targeted drug is developed by Nanfang Hospital, Southern Medical University (see full Nanfang Hospital, Southern Medical University pipeline at /company/nanfang-hospital-southern-medical-university).

What drug class is targeted drug in?

targeted drug belongs to the Tyrosine kinase inhibitor class. See all Tyrosine kinase inhibitor drugs at /class/tyrosine-kinase-inhibitor.

What development phase is targeted drug in?

targeted drug is in Phase 3.

What are the side effects of targeted drug?

Common side effects of targeted drug include Rash, Diarrhea, Fatigue.

What does targeted drug target?

targeted drug targets EGFR and is a Tyrosine kinase inhibitor.

Drug class: All Tyrosine kinase inhibitor drugs
Target: All drugs targeting EGFR
Manufacturer: Nanfang Hospital, Southern Medical University — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Non-small cell lung cancer, EGFR mutation positive
Indication: Drugs for Head and neck cancer, EGFR mutation positive

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