Glenmark Specialty S.A. (GSSA), a subsidiary of Glenmark Pharmaceuticals, has signed an exclusive licensing and distribution agreement with Jiangsu Hansoh Pharmaceutical Group for Aumolertinib. This third-generation EGFR-TKI is designed to treat non-small cell lung cancer (NSCLC).

Under the partnership, Glenmark secures development and commercialization rights for several regions, including the Middle East, Africa, Southeast and South Asia, Australia, New Zealand, and Russia/CIS. In exchange, Hansoh Pharma will receive an upfront payment in the low double-digit millions, with potential milestone payments and royalties that could eventually exceed $1 billion.

"At Glenmark, we remain focused on building a growth-oriented oncology business across high-potential markets. Aumolertinib is a strategic addition that strengthens our near-term commercial pipeline and enhances our ability to serve patients with EGFR-mutated lung cancer. This collaboration reinforces our disciplined approach to expanding our innovative portfolio and widening access to advanced cancer care across key markets," said Glenn Saldanha, Chairman and Managing Director, Glenmark Pharmaceuticals Ltd.

Aumolertinib, (marketed as Ameile in China and Aumseqa in the United Kingdom and Europe), as a monotherapy, has received marketing authorization from the UK MHRA and is indicated the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations, and the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.

It has also received approval for four indications in China (second-line T790M mutation, first-line NSCLC EGFR mutated, unresectable Stage III post-chemoradiotherapy, and adjuvant Stage II-IIIB NSCLC). Aumolertinib became Hansoh Pharma's first innovative drug approved in an overseas market and the first China-developed EGFR-TKI to be launched internationally.