Glenmark signed license agreement for further developing, registering, and commercializing Envafolimab in India, Asia Pacific

Glenmark signed license agreement for further developing, registering, and commercializing Envafolimab in India, Asia Pacific, Middle East and Africa, Russia, CIS, and Latin America

• Glenmark will be responsible for further developing, registering, and commercializing Envafolimab in India, Asia Pacific, Middle East and Africa, Russia, CIS, and Latin America.

• 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.

• Jiangsu Alphamab will be responsible of manufacturing KN035 within and outside the Territory.

Glenmark Specialty S.A. (GSSA), a subsidiary of Glenmark Pharmaceuticals Ltd. (Glenmark), today announced the signing of a license agreement with JIANGSU ALPHAMAB BIOPHARMACEUTICALS CO., LTD (Jiangsu Alphamab) and 3D MEDICINES (BEIJING) CO., LTD. (3DMed), (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, commercialize, 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 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.” remarked Glenn Saldanha, Chairman & Managing Director, Glenmark Pharmaceuticals Ltd.

Envafolimab, under the brand name ENWEIDA (恩維達®) 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.* Overall, dMMR prevalence across 13 tumor types (based on 54 papers and 20,383 patients) was estimated at 16% (11%–22%)**, 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 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.