Glenmark Secures Multi-Regional Rights for Aumolertinib from Hansoh Pharma
Filing Summary
Glenmark Pharmaceuticals Ltd., through its subsidiary Glenmark Specialty S.A., has entered an exclusive agreement with Jiangsu Hansoh Pharmaceutical Group Co., Ltd. for the rights to develop and commercialize Aumolertinib, a third-generation EGFR-TKI, across several regions. The agreement includes an upfront payment in the low double-digit million USD range, with potential milestone payments exceeding US$1 billion, plus tiered royalties. This strategic move expands Glenmark’s oncology portfolio in markets including the Middle East, Africa, and Southeast Asia. Aumolertinib is approved for treating non-small cell lung cancer.
Glenmark Pharmaceuticals Ltd., through its wholly owned subsidiary Glenmark Specialty S.A. (GSSA), has announced an exclusive license, collaboration, and distribution agreement with Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (Hansoh Pharma). The agreement grants Glenmark the rights to develop and commercialize Aumolertinib, a third-generation Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI), for the treatment of non-small cell lung cancer (NSCLC) in several regions.
Under the terms of the agreement, Glenmark will make an upfront payment to Hansoh Pharma in the low double-digit million USD range. Additionally, Hansoh Pharma is eligible to receive potential regulatory and commercial milestone payments that could exceed US$1 billion. The agreement also includes tiered royalties on net sales of Aumolertinib in the licensed territories. These financial terms reflect the strategic importance of the collaboration for both parties.
The scope of the agreement covers the development and commercialization of Aumolertinib in territories including the Middle East, Africa, Southeast and South Asia, Australia, New Zealand, Russia/CIS, and selected Caribbean countries. Aumolertinib, marketed as Ameile® in China and Aumseqa® in the United Kingdom and Europe, is approved for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations. It is also approved for treating adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.
Aumolertinib has received marketing authorization from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and has four approved indications in China. These include second-line treatment for T790M mutation, first-line treatment for EGFR mutated NSCLC, treatment for unresectable Stage III post-chemoradiotherapy, and adjuvant treatment for Stage II–IIIB NSCLC. This drug represents Hansoh Pharma’s first innovative drug approved in an overseas market and the first China-developed EGFR-TKI to be launched internationally.
The agreement involves Glenmark’s focus on expanding its oncology portfolio in high-potential markets. The partnership with Hansoh Pharma aligns with Glenmark’s strategy to enhance its commercial pipeline and improve access to advanced cancer care. The collaboration is expected to reinforce Glenmark’s presence in the oncology sector across key regions.
Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise in China, focusing on therapeutic areas such as oncology, anti-infectives, and central nervous system disorders. The company has launched several innovative drugs in China and is recognized as a top pharmaceutical R&D enterprise.
Glenmark Pharmaceuticals Ltd. is a global pharmaceutical company with a presence in branded, generics, and OTC segments, focusing on respiratory, dermatology, and oncology therapeutic areas. The company operates 11 manufacturing facilities across four continents and serves over 80 countries. Glenmark is committed to expanding its innovative portfolio and enhancing its global market presence.