Glenmark Specialty SA signs license agreement with Jiangsu Alphamab, 3D Medicines for Envafolimab, ET HealthWorld


Mumbai: Glenmark Specialty SA announced the signing of a license agreement with Jiangsu Alphamab Biopharmaceuticals Co, Ltd and 3D Medicines Co, Ltd (together as the Licensors), 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.

“This is an important milestone for Glenmark, as through this transformational deal, we gain access to the first recombinant humanised 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,” remarked Glenn Saldanha, Chairman & Managing Director, Glenmark Pharmaceuticals Ltd.

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. 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.

Overall, dMMR prevalence across 13 tumour types (based on 54 papers and 20,383 patients) was estimated at 16 per cent (11-22 per cent), which makes it quite a widespread genetic signature among cancer patients. Envafolimab has the potential to provide an effective treatment for such populations across emerging markets and beyond.

Furthermore, Envafolimab is currently being developed in the US 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 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.

  • Published On Jan 25, 2024 at 02:51 PM IST

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