Glenmark Pharmaceuticals Ltd said its subsidiary Glenmark Specialty SA (GSSA) has entered into a licensing agreement with Jiangsu Alphamab Biopharmaceuticals Co and 3D Medicines (Beijing) Co Ltd for KN035 (Envafolimab), which is used to treat cancer. Under the agreement, Glenmark will license KN035 (Envafolimab) in India, Asia Pacific, the Middle East, Africa, Russia, CIS and Latin America, according to the company.
Glenmark is responsible for developing, registering and commercializing Envafolimab in the region.
For the licensor, Jiangsu Alphamab will receive a minimum launch fee of two million dollars and additional royalties of three million dollars based on sales during the agreement. Depending on the level of net sales, the increase is one to two digits, according to the statement.
Jiangsu Alphamab is responsible for the production of KN035 and will also be the exclusive supplier of the product."This is an essential milestone for Glenmark, as this historic transaction gives us access to the first humanized single-domain antibody against PD-L1 in a universal Sub-Q format in broad areas of the world. Glenn Saldanha, President and CEO of Glenmark Pharmaceuticals, added: “We are excited about bringing this new immuno-oncology product to cancer patients in emerging markets and will have a significant opportunity to improve access to this Saving treatment."
Envafolimab, under the brand name ENWEIDA, was approved by the China National Medical Products Administration (China NMPA) in November 2021 for treating elderly patients with certain types of advanced solid tumors. It is also included in the "Ready Freezer List" and the "List." NMPA said.
In addition, Envafolimab is being developed in the United States by Tracon Pharma in a large trial for soft tissue sarcoma (STS). This drug has received two orphan drug designations from the US Food and Drug Administration (USFDA) for biliary tract cancer and soft tissue sarcoma (STS) and Fast Track designation for STS.
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