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Glenmark, Jiangsu Alphamab, 3D Medicines Ink Licensing Deal for Envafolimab

NEW YORK – Glenmark Pharmaceuticals on Thursday said it signed a license agreement with Jiangsu Alphamab Biopharmaceuticals and 3D Medicines to develop, register, and commercialize the PD-L1 inhibitor envafolimab in certain territories.

Envafolimab is marketed under the brand name Enweida in China as a treatment for patients with microsatellite instability high (MSI-H) or deficient mismatch repair (dMMR) advanced solid tumors.

Under the terms of the agreement, Jiangsu Alphamab will be the exclusive supplier for the product. The territories covered include India; Asia-Pacific except Singapore, Thailand, and Malaysia; the Middle East; Africa; Russia; the Commonwealth of Independent States; and Latin America. 3D Medicines retains the right to develop and commercialize the drug outside those territories. Jiangsu and 3D Medicines will receive an upfront payment in the low millions of US dollars, and additional milestone payments potentially in the triple-digit millions based on sales. They will also receive a percentage of net sales as a royalty fee.

"Through this transformational deal, we gain access to the first recombinant humanized single domain antibody against PD-L1 in a subcutaneous formulation for a wide territory globally," Glenn Saldanha, chairman and managing director for Glenmark Pharmaceuticals, said in a statement.

Tracon Pharma is conducting a pivotal clinical trial of envafolimab with Bristol Myers Squibb's CTLA-4-targeted monoclonal antibody Yervoy (ipilimumab) in the US in soft tissue sarcoma and myxofibrosarcoma. The US Food and Drug Administration has granted orphan drug designation to envafolimab for advanced biliary tract cancer and soft tissue sarcoma and fast-track designation for soft tissue sarcoma.