Last reviewed 2026-04-22 · How we verify

Abivertinib Maleate Capsules

Hangzhou ACEA Pharmaceutical Research Co., Ltd. · Phase 3 active Small molecule

Abivertinib Maleate Capsules is a EGFR tyrosine kinase inhibitor Small molecule drug developed by Hangzhou ACEA Pharmaceutical Research Co., Ltd.. It is currently in Phase 3 development for Non-small cell lung cancer with EGFR mutations.

Abivertinib is a tyrosine kinase inhibitor that targets mutant EGFR and other kinases involved in cancer cell proliferation.

Abivertinib is a tyrosine kinase inhibitor that targets mutant EGFR and other kinases involved in cancer cell proliferation. Used for Non-small cell lung cancer with EGFR mutations.

At a glance

Generic name	Abivertinib Maleate Capsules
Sponsor	Hangzhou ACEA Pharmaceutical Research Co., Ltd.
Drug class	EGFR tyrosine kinase inhibitor
Target	EGFR (Epidermal Growth Factor Receptor)
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

Abivertinib selectively inhibits epidermal growth factor receptor (EGFR) tyrosine kinase, particularly mutations associated with non-small cell lung cancer. By blocking EGFR signaling, it prevents downstream activation of proliferation and survival pathways in cancer cells. The drug is designed to overcome certain resistance mechanisms in EGFR-mutant tumors.

Approved indications

Non-small cell lung cancer with EGFR mutations

Common side effects

Diarrhea
Rash
Nausea
Vomiting
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:

Abivertinib Maleate Capsules CI brief — competitive landscape report
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Hangzhou ACEA Pharmaceutical Research Co., Ltd. portfolio CI

Frequently asked questions about Abivertinib Maleate Capsules

What is Abivertinib Maleate Capsules?

Abivertinib Maleate Capsules is a EGFR tyrosine kinase inhibitor drug developed by Hangzhou ACEA Pharmaceutical Research Co., Ltd., indicated for Non-small cell lung cancer with EGFR mutations.

How does Abivertinib Maleate Capsules work?

Abivertinib is a tyrosine kinase inhibitor that targets mutant EGFR and other kinases involved in cancer cell proliferation.

What is Abivertinib Maleate Capsules used for?

Abivertinib Maleate Capsules is indicated for Non-small cell lung cancer with EGFR mutations.

Who makes Abivertinib Maleate Capsules?

Abivertinib Maleate Capsules is developed by Hangzhou ACEA Pharmaceutical Research Co., Ltd. (see full Hangzhou ACEA Pharmaceutical Research Co., Ltd. pipeline at /company/hangzhou-acea-pharmaceutical-research-co-ltd).

What drug class is Abivertinib Maleate Capsules in?

Abivertinib Maleate Capsules belongs to the EGFR tyrosine kinase inhibitor class. See all EGFR tyrosine kinase inhibitor drugs at /class/egfr-tyrosine-kinase-inhibitor.

What development phase is Abivertinib Maleate Capsules in?

Abivertinib Maleate Capsules is in Phase 3.

What are the side effects of Abivertinib Maleate Capsules?

Common side effects of Abivertinib Maleate Capsules include Diarrhea, Rash, Nausea, Vomiting, Fatigue.

What does Abivertinib Maleate Capsules target?

Abivertinib Maleate Capsules targets EGFR (Epidermal Growth Factor Receptor) and is a EGFR tyrosine kinase inhibitor.

Drug class: All EGFR tyrosine kinase inhibitor drugs
Target: All drugs targeting EGFR (Epidermal Growth Factor Receptor)
Manufacturer: Hangzhou ACEA Pharmaceutical Research Co., Ltd. — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Non-small cell lung cancer with EGFR mutations
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