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Glenmark Specialty S.A. (GSSA), a wholly owned subsidiary of India-based Glenmark Pharmaceuticals, has entered into an exclusive license, collaboration and distribution agreement with Jiangsu Hansoh Pharmaceutical Group Co., for Aumolertinib, a third-generation Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) for the treatment of non-small cell lung cancer (NSCLC).
Under the terms of the agreement, Glenmark receives exclusive rights to develop and commercialise Aumolertinib across its licensed territories: Middle East and Africa, Southeast & South Asia, Australia, New Zealand, Russia/CIS and a few selected Caribbean countries covered by the agreement.
China's Hansoh Pharma will receive an upfront payment of low double-digit million USD, followed by potential regulatory and commercial milestone payments possibly cumulating to over $1 billion, in addition to tiered royalties on net sales in the licensed territories.
Aumolertinib, (marketed as Ameile® in China and Aumseqa® in the United Kingdom and Europe), as a monotherapy, has received marketing authorisation 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.
