Glenmark Specialty SA has signed a licensing agreement with Jiangsu Alphamab Biopharmaceuticals and 3D Medicines (Beijing) Co for envafolimab ( KN035) across India, Asia Pacific, West Asia and Africa, Russia, CIS, and Latin America.
GSSA, a Glenmark Pharmaceuticals subsidiary, will receive an exclusive licence from Jiangsu Alphamab and 3DMed to develop, register, and commercialise envafolimab for the oncology indication in the territory. Jiangsu Alphamab will be the exclusive supplier of the product, the note said.
Jiangsu Alphamab “will receive a low double-digit million US dollar amount up to launch, and an 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,” Glenmark said.
Through this “transformational deal”, Glenmark gains access to “the first recombinant humanised single-domain antibody against PD-L1 in a Sub-Q formulation for a wide territory globally,” said Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals.
Envafolimab injectable is a recombinant single-domain antibody, independently invented by Alphamab Oncology and co-developed with 3DMed Beijing since 2016. On December 20, 2019, Tracon Pharmaceuticals Inc was granted the exclusive and non-transferable licence in the US, Canada, Mexico and each of their dependent territories for KN035 in the field of human therapeutic applications for sarcoma. On March 30, 2020, Jiangsu Alphamab, a wholly-owned subsidiary of Alphamab Oncology, Jiangsu Simcere Pharmaceutical Co, a subsidiary of Simcere Pharmaceutical Group Limited, and 3DMed Beijing entered into a cooperation agreement whereby Jiangsu Simcere was granted an exclusive marketing right in respect of oncology indications of KN035 and the rights of first refusal for in-licenses or transfers in mainland China.
Envafolimab, under the brand name ENWEIDA, 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 or deficient mismatch repair (dMMR) advanced solid tumour, a company note said. Over 30,000 patients have been given this treatment in China, where, in December 2023, it was also officially included in the ‘List of Breakthrough Therapies’ by the NMPA, the note added.
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Envafolimab is also currently being developed in the US by Tracon Pharma in a pivotal trial in soft tissue sarcoma (STS) subtypes including undifferentiated pleomorphic sarcoma (UPS) and the genetically related myxofibrosarcoma.
Envafolimab has obtained two orphan drug designations from the US Food and Drug Administration, for advanced biliary tract cancer and 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.