Glenmark Pharmaceuticals has taken a major step in strengthening its global oncology portfolio through its wholly owned subsidiary, Glenmark Specialty S.A. (GSSA). The company has entered into an exclusive license, collaboration, and distribution agreement with China-based Jiangsu Hansoh Pharmaceutical Group Co., Ltd. for Aumolertinib, a third-generation EGFR tyrosine kinase inhibitor (EGFR-TKI) used in the treatment of non-small cell lung cancer (NSCLC).
Under the terms of the agreement, Glenmark has secured exclusive rights to develop and commercialize Aumolertinib across a wide set of international markets. These include the Middle East and Africa, Southeast and South Asia, Australia, New Zealand, Russia and CIS countries, along with select Caribbean markets covered under the deal. In return, Hansoh Pharma will receive an upfront payment in the low double-digit million US dollars, along with regulatory and commercial milestone payments that could cumulatively exceed US$1 billion. The agreement also includes tiered royalties on net sales generated in Glenmark’s licensed territories.
Aumolertinib is already an established therapy in key global markets. Marketed as Ameile® in China and Aumseqa® in the United Kingdom and Europe, the drug has received marketing authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA). It is approved as a monotherapy for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations, as well as for patients with EGFR T790M mutation-positive NSCLC.
In China, Aumolertinib has been approved for multiple indications, including second-line treatment for T790M mutation-positive NSCLC, first-line treatment of EGFR-mutated NSCLC, unresectable Stage III disease following chemoradiotherapy, and adjuvant treatment for Stage II to IIIB NSCLC. These approvals highlight the drug’s broad clinical utility across different stages of lung cancer.
Notably, Aumolertinib marked a significant milestone for Hansoh Pharma, becoming its first innovative drug approved in an overseas market. It also holds the distinction of being the first China-developed EGFR-TKI to be launched internationally, underscoring the growing global relevance of Chinese pharmaceutical innovation.
