Hansoh Pharmaceutical Group Receives Landmark EU Approval for Aumolertinib Mesylate Tablets as Monotherapy in Advanced NSCLC

Key Highlights for Investors

• European Union (EU) Approval: On February 12, 2026, Hansoh Pharmaceutical Group’s innovative drug, Aumolertinib Mesylate Tablets (marketed as Ameile® in China and Aumseqa® outside China), received approval from the European Commission (EC) for use as a monotherapy in the EU.
• Indications Covered: The approval covers two major indications:
  • First-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.
  • Treatment of adult patients with advanced EGFR T790M mutation-positive NSCLC.
• Regulatory Milestone: The EC approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), underlining the drug’s robust clinical profile and regulatory acceptance.

Details of Aumolertinib Mesylate Tablets’ Development and Approvals

Aumolertinib Mesylate Tablets are the first original third-generation EGFR-TKI innovative drug developed in China. The drug has garnered significant regulatory traction, with five major indications approved by the Chinese National Medical Products Administration (NMPA):

1. In 2020, approved for treatment of patients with locally advanced or metastatic NSCLC with T790M mutation who have progressed on or after EGFR-TKI therapy.
2. In 2021, approved as first-line treatment for adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.
3. In 2025, approved for treatment of patients with locally advanced, unresectable NSCLC whose disease has not progressed following definitive platinum-based chemoradiotherapy and whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.
4. In 2025, approved for adjuvant treatment of adult patients with stage II to IIIB NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, and who have undergone tumor resection with or without prior adjuvant chemotherapy.
5. In 2026, Ameile was approved in combination with pemetrexed and platinum-based chemotherapy as the first-line treatment for adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R) mutations.

Additionally, the drug was approved by the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) for marketing in 2025, signaling its growing international recognition and market expansion potential.

Why This Matters to Shareholders

• Significant Market Expansion: The EU approval opens up one of the world’s largest and most lucrative pharmaceutical markets to Hansoh Pharmaceutical Group. This is expected to drive revenue growth and strengthen the company’s international presence.
• Validation of R&D Strength: The EC and EMA’s endorsement not only validates the quality and innovation of Hansoh’s R&D pipeline but also enhances the company’s reputation among global investors and partners.
• Potential Share Price Catalyst: Given the importance of the EU market entry and the positive regulatory momentum, this news is highly price sensitive. It may significantly affect Hansoh Pharmaceutical’s share value in the short to medium term due to the anticipated increase in sales, profits, and market capitalization.
• Broader Impact: The multiple approvals for various NSCLC indications, including both monotherapy and combination therapy settings, position Aumolertinib Mesylate Tablets as a core growth driver for the company’s oncology franchise.

Corporate Leadership

The announcement was made by the Board of Hansoh Pharmaceutical Group, chaired by Ms. Zhong Huijuan, with a team of experienced executive and independent non-executive directors, underscoring the company’s solid corporate governance and leadership.

Conclusion

Hansoh Pharmaceutical Group’s successful EU approval for Aumolertinib Mesylate Tablets as a monotherapy for advanced NSCLC is a major corporate milestone and a potential game-changer for the company’s global strategy. Investors should closely monitor further commercial rollouts and post-marketing studies, as these developments may further drive the company’s valuation and competitive position in the global oncology market.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. Investors should conduct their own research or consult with a financial advisor before making any investment decisions. The author and publisher accept no liability for any loss arising from reliance on this information.

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