By Fineline Cube 
Huadong Medicine (SHE: 000963) announced that its Class 1 innovative drug Mefatinib Tablets has received marketing approval from the National Medical Products Administration (NMPA). The approval designates Mefatinib as the first‑line therapy for adult patients with locally advanced or metastatic non‑small‑cell lung cancer (NSCLC) carrying the EGFR exon 21 (L858R) substitution mutation.
Key Product Highlights
| Feature | Detail |
|---|---|
| Drug | Mefatinib Tablets (oral, irreversible EGFR/HER2 inhibitor) |
| Indication | First‑line therapy for EGFR L858R‑positive NSCLC |
| Regulatory Status | NMPA Class 1 innovative drug approval |
| Mechanism | Covalent, irreversible inhibition of EGFR/HER2 kinase domains → ↓ ErbB signaling → tumor growth arrest |
| Intellectual Property | Fully independent IP portfolio owned by Huadong Medicine |
Clinical & Commercial Impact
- Unmet Need: EGFR L858R is a common driver mutation in NSCLC; existing therapies lack irreversible inhibition with the same potency.
- First‑In‑Class: Mefatinib is the first wholly domestically developed, irreversible EGFR/HER2 inhibitor approved in China.
- Strategic Partnership: In 2015, Huadong’s subsidiary Zhongmei Huadong secured rights to Mefatinib Maleate API and the technology platform from Suzhou Medek Biopharma and Hangzhou Huadong Medicine Group New Drug Research Institute, consolidating the drug’s development pathway.
Regulatory Milestone
- Approval Pathway: NMPA granted marketing approval under the “Class 1 Innovative Drug” category, reflecting the drug’s novelty and therapeutic potential.
- Future Outlook: Huadong plans accelerated phase‑IV post‑marketing studies to further define safety and real‑world effectiveness, and to explore combination regimens with immunotherapies.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech