FAB Celebrates Hansoh Pharma’s Almonertinib Approval by UK MHRA for NSCLC, Bolstering Chinese Drug Globalization with IRC Support

June 4, 2025 – Hansoh Pharma announced that its innovative drug Almonertinib Mesilate Tablets (UK brand name: Aumseqa®) has received marketing authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA). Aumseqa® is approved as monotherapy for:

• First-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating epidermal growth factor receptor (EGFR) mutations.

• Treatment of adults with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.

Source: Hansoh Pharma

Almonertinib Mesilate Tablets are a third-generation EGFR-TKI innovative drug. Previously approved for four indications in China, FAB contributed to the approval of three indications:
• March 2020: Approved for locally advanced or metastatic NSCLC patients with EGFR-TKI treatment progression and EGFR T790M mutation positivity.
• December 2021: Approved as first-line treatment for adults with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletion or exon 21 (L858R) substitution mutations.
• March 2025: Approved for unresectable locally advanced NSCLC patients with EGFR exon 19 deletion or exon 21 (L858R) substitution mutations who showed no disease progression after platinum-based definitive chemoradiotherapy.

Since 2018, FAB has collaborated with Hansoh Pharma, providing professional and efficient Independent medical imaging services for multiple clinical studies of Almonertinib Mesilate Tablets.

As a long-term partner, FAB extends warm congratulations to Hansoh Pharma on Aumseqa®’s UK approval. This milestone marks Almonertinib as Hansoh’s first innovative drug entering overseas markets and China’s first domestically developed EGFR-TKI approved internationally. This achievement is the fruit of collaborative dedication and relentless efforts in clinical research between both parties. Notably, Almonertinib’s review process with the European Medicines Agency (EMA) is progressing actively, promising broader patient access soon.

FAB looks forward to joining hands with more partners to accelerate innovative drug development and global commercialization, empowering Chinese drug innovation worldwide and delivering enhanced treatment options to patients globally.