Glenmark Specialty S.A. on Thursday announced the signing of a license agreement with Jiagngsu Alphamab Biopharmaceuticals and 3D Medicines for Envafolimab, a cancer immunotherapy, for India, Asia Pacific, Middle East and Africa, Russia, CIS, and Latin America (the Territory).
Under the terms of the agreement, GSSA will receive from Jiangsu Alphamab and 3DMed, an exclusive license to develop, register, commercialize, Envafolimab for the oncology indication in the Territory. Jiangsu Alphamab will be the exclusive supplier of the product.
According to the company’s press statement, Jiangsu Alphamab (on behalf of the Licensors) will receive a low double-digit Million US Dollar amount up to launch, an additional triple digit Million US Dollar milestone payments based on sales performance across the length of the agreement, and a royalty fee of single-to-double-digits percentage according to the level of net sales.
“This is an important milestone for Glenmark, as through this transformational deal, we gain access to the first recombinant humanized single domain antibody against PD-L1 in a Sub-Q formulation for a wide territory globally. We are excited at the opportunity to take this innovative immuno-oncology product to cancer patients across the emerging markets and meaningfully contribute towards improving their access to potentially life-saving treatments,” Glenn Saldanha, Chairman & Managing Director, Glenmark Pharmaceuticals Ltd. said in a statement.
Envafolimab, under the brand name ENWEIDA has been approved in China by the National Medical Products Administration (Chinese NMPA) in November 2021 as the global-first subcutaneous injection PD-L1 inhibitor for the treatment of adult patients with previously treated microsatellite instability-high (MSI-H) or deficient MisMatch repair (dMMR) advanced solid tumor.
Over 30,000 patients have already greatly benefited from this innovative treatment in China where, in December 2023, it has also been officially included in the ‘List of Breakthrough Therapies’ by the NMPA.
Furthermore, Envafolimab is currently being developed in the USA by Tracon Pharma in a pivotal trial in soft tissue sarcoma (STS) subtypes including Undifferentiated Pleomorphic Sarcoma (UPS) and the genetically related myxofibrosarcoma (MFS).
Envafolimab has obtained two orphan drug designation from the U.S. FDA for advanced biliary tract cancer and soft tissue sarcoma (STS) and a Fast Track designation for STS. Additional indications such as Biliary Tract cancer and non-small cell lung cancer are currently in development.
