Hansoh Pharmaceutical Re-submits EU Marketing Authorization Application for Aumolertinib and Gains EMA Acceptance

HONG KONG — Hansoh Pharmaceutical Group Company Limited (HKEX: 03692), a China-based pharmaceutical company, has re-submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for aumolertinib, its proprietary third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). The EMA has confirmed acceptance of the application, according to a voluntary announcement issued by the company.

The re-submission marks a significant step in Hansoh Pharma's efforts to bring aumolertinib to the European market. Acceptance by the EMA means the application has passed the initial validation check and will proceed to full scientific review by the Committee for Medicinal Products for Human Use (CHMP).

Aumolertinib is an oral, selective EGFR TKI designed to target both EGFR-TKI sensitizing mutations and the T790M resistance mutation in patients with non-small cell lung cancer (NSCLC). Third-generation EGFR TKIs represent an important treatment option for patients whose disease has progressed after first-line EGFR inhibitor therapy.

The announcement, classified as a business development update, signals Hansoh's continued push into international markets. The company, listed on the Hong Kong Stock Exchange under stock code 03692, has been expanding its global regulatory footprint for its oncology pipeline.

Details regarding the specific indication sought, clinical data supporting the application, and the anticipated review timeline were not disclosed in the announcement. The EMA's standard review process for a MAA typically takes approximately 210 days, excluding clock stops during which the agency may request additional information from the applicant.

Hansoh Pharmaceutical is one of China's leading innovative pharmaceutical companies, with a portfolio spanning oncology, metabolic diseases, central nervous system disorders, and anti-infective therapies. The company's focus on developing first-in-class and best-in-class therapies has positioned it as a notable player in the global pharmaceutical landscape.