Huadong Medicine's subsidiary wins NMPA approval for new oncology drug

Huadong Medicine announced its wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., received drug registration certificates from the National Medical Products Administration (NMPA) for its Class 1 innovative drug, Mifanertinib Maleate Tablets (Meiruitong®). The drug is approved for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients with EGFR exon 21 (L858R) substitution mutations. The product will be available in 45mg and 60mg strengths. The direct R&D investment for this project reached approximately CNY 306m as of September 30, 2025.

Mifanertinib Maleate Tablets is a novel, potent, selective, and orally active irreversible EGFR/HER2 small molecule inhibitor. It has demonstrated superior progression-free survival (mPFS) compared to gefitinib in a Phase III clinical trial for EGFR-mutated advanced non-squamous NSCLC, with a hazard ratio (HR) of 0.68 overall, and 0.55 for patients with EGFR L858R substitution mutations. The company anticipates a new treatment option for patients and will actively promote commercialization.

This approval is not expected to significantly impact Huadong Medicine's current financial position or operating results. However, future drug sales are subject to industry policy changes, market demand, and competition, which may introduce uncertainty regarding the company's future profits. Investors are advised to exercise caution.