Glenmark Specialty S.A. (GSSA), a subsidiary of Glenmark Pharmaceuticals have signed a license agreement with Jiangsu Alphamab Biopharmaceuticals and 3D Medicines (BEIJING), for KN035 (Envafolimab) 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, commercialise, Envafolimab for the oncology indication in the Territory. Jiangsu Alphamab will be the exclusive supplier of the product. Jiangsu Alphamab (on behalf of the Licensors) will receive a low double digit million US dollar amount up to launch, 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.
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 tumour. In December 2023, it has been officially included in the “List of Breakthrough Therapies” by the NMPA.
Overall, dMMR prevalence across 13 tumour types (based on 54 papers and 20,383 patients) was estimated at 16 per cent, which makes it quite a widespread genetic signature among cancer patients. Envafolimab has the potential to provide an effective treatment for such population across Emerging Markets and beyond.
Furthermore, Envafolimab is currently being developed in the US by Tracon Pharma in a 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 US 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.