Glenmark will be responsible for further developing, registering, and commercialising Envafolimab in these regions.
On behalf of the licensors, Jiangsu Alphamab 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 depending on the level of net sales, the statement said.
Jiangsu Alphamab will be responsible for the manufacturing of KN035 and will be the exclusive supplier of the product, it added.
“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,” Glenmark Pharmaceuticals Chairman & Managing Glenn Saldanha said.
Further, he said,”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.” Envafolimab, under the brand name ENWEIDA was approved in China by the National Medical Products Administration (Chinese NMPA) in November 2021 for the treatment of adult patients with certain types of advanced solid tumour. It has also been officially included in the “List of Breakthrough Therapies” by the NMPA, the statement said. Further, Envafolimab is currently being developed in the USA by Tracon Pharma in a pivotal trial in soft tissue sarcoma (STS) subtypes.
The drug has obtained two orphan drug designation from the USFDA (US Food and Drug Administration) 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, it added.