Limertinib Tablets 80?mg ×?20 – by Osscon Pharma | Research Use Only (3rd?Gen EGFR?TKI)

描述

Limertinib Tablets Description

Product name: Limertinib Tablets (Aoyixin/Aosaikang Pharmaceutical)
Packaging specifications: 80mg*20 tablets ? Product dosage form: tablets ? Packaging unit: box
Approval number: National Medicine Standard H20250004 ? Drug standard code: 86901425001248
Manufacturer: Jiangsu Aosaikang Pharmaceutical Co., Ltd.

Limertinib (also known as OuyiXin®) is an oral, irreversible third-generation EGFR?TKI developed jointly by Innovent Biologics and Jiangsu Osscon Pharma. It’s specifically designed to inhibit both common activating EGFR mutations (exon?19 deletion, L858R) and the resistance-associated T790M mutation in NSCLC

In January 2025, China’s National Medical Products Administration (NMPA) approved limertinib (H20250004) for adult patients with locally advanced or metastatic T790M-positive NSCLC

Key clinical outcomes from a Phase 2b trial (N=301):

• Overall response rate (ORR): 68.8%

• Disease control rate (DCR): 92.4%

• Median progression?free survival (PFS): 11.0 months

• CNS-specific ORR: 65.9%, PFS: 10.6 months?

Additionally, a Phase 3 trial comparing limertinib to gefitinib as a first-line therapy (for EGFR-mutant NSCLC) met its primary endpoint. A second NDA is under NMPA review for this indication

Limertinib Tablets Product Specifications

Limertinib Tablets Mechanism & Performance Profile

• Dual-target inhibition: Effective against EGFR sensitizing mutations and the T790M resistance mutation?

• Central nervous system activity: Demonstrated CNS response in brain-metastatic NSCLC cases?

• Phase 3 first-line study: Successfully met endpoint versus gefitinib in treatment-naïve EGFR-mutant NSCLC?

• Combination development: Investigational use with c-Met inhibitors (e.g., ASKC202) to overcome resistance?

? Why Choose OuyiXin Limertinib?

• Third?generation EGFR inhibitor with full regulatory clearance

• Proven efficacy in CNS metastatic models

• Phase 3 efficacy validating its first-line use

• Tablet format ideal for controlled dosing in preclinical studies

? Related Research Compounds

• Osimertinib (Tagrisso®) – Widely used third?gen EGFR?TKI

• Lazertinib – Another CNS-penetrant EGFR?TKI

• ASKC202 – C?Met inhibitor explored in combination

• First-gen EGFR?TKIs (Erlotinib, Gefitinib)

? Summary

Limertinib 80?mg Tablets (OuyiXin®) deliver a research-grade, third-generation EGFR?TKI that addresses T790M mutation and brain metastases in NSCLC, backed by strong Phase?2b data (ORR 68.8%, PFS 11?mo) and first-line efficacy validation.
?? For laboratory research or analytical use only.