Pharma Focus Asia

Jiangsu Alphamab Biopharmaceuticals, 3D Medicines (Beijing), and Glenmark have signed a License Agreement for KN035 (Envafolimab) to be Distributed Globally

Thursday, January 25, 2024

Glenmark Specialty S.A. (GSSA), a subsidiary of Glenmark Pharmaceuticals Ltd., recently inked a license agreement with JIANGSU ALPHAMAB BIOPHARMACEUTICALS CO., LTD (Jiangsu Alphamab) and 3D MEDICINES (BEIJING) CO., LTD. (3DMed), collectively referred to as the Licensors. This agreement grants GSSA an exclusive license for the development, registration, and commercialization of Envafolimab (KN035) for oncology indications in specific regions, including India, Asia Pacific, Middle East, Africa, Russia, CIS, and Latin America.

As per the agreement terms, Jiangsu Alphamab will serve as the exclusive supplier of Envafolimab, and GSSA will make payments, including a low double-digit Million US Dollar amount before the product launch, additional triple-digit Million US Dollar milestone payments based on sales performance, and a royalty fee tied to net sales, ranging from single to double digits.

Glenn Saldanha, Chairman & Managing Director of Glenmark Pharmaceuticals Ltd., expressed excitement about this transformative deal, emphasizing the significance of gaining access to the first recombinant humanized single domain antibody against PD-L1 in a Sub-Q formulation for a broad global territory. He underlined the company's commitment to bringing this innovative immuno-oncology product, known as ENWEIDA (Envafolimab), to cancer patients in emerging markets.

Envafolimab has already received approval in China as a subcutaneous injection PD-L1 inhibitor for treating adult patients with previously treated microsatellite instability-high (MSI-H) or deficient MisMatch repair (dMMR) advanced solid tumors. With its potential to effectively treat a significant population of cancer patients with dMMR, Envafolimab is expected to make a meaningful impact in emerging markets and beyond.

Notably, Envafolimab is undergoing development in the USA by Tracon Pharma for soft tissue sarcoma (STS) subtypes, including Undifferentiated Pleomorphic Sarcoma (UPS) and myxofibrosarcoma (MFS). The drug has received orphan drug designations for advanced biliary tract cancer and STS from the U.S. FDA and a Fast Track designation for STS. Additional indications, such as Biliary Tract cancer and non-small cell lung cancer, are currently in the developmental pipeline.

KN035 (Envafolimab Injectable) is a recombinant single domain antibody against PD-L1 fused with human Fc. Developed by Alphamab Oncology and co-developed with 3DMed Beijing since 2016, it holds promise as an innovative therapeutic option for various oncology indications. The licensing agreement marks a significant step in expanding access to this groundbreaking treatment across diverse global regions.



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