Glenmark Signs License Pact With Jiangsu Alphamab, 3D Medicines For Cancer Drug

It will be Jiangsu Alphamab’s responsibility to manufacture KN035, and they will be the exclusive supplier of the product, it added

The signed agreement states that Glenmark will get the license for KN035 (Envafolimab) in India, Asia Pacific, the Middle East, Africa, Russia, CIS, and Latin America, the company said

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Glenmark Pharmaceuticals’s arm Glenmark Specialty S A (GSSA) has signed a license agreement with Jiangsu Alphamab Biopharmaceuticals and 3D Medicines (Beijing) for KN035 (Envafolimab), which is used in cancer treatment, the company said on Thursday.

The signed agreement states that Glenmark will get the license for KN035 (Envafolimab) in India, Asia Pacific, the Middle East, Africa, Russia, CIS, and Latin America, the company said in a statement. In addition, the company will be responsible for further developing, registering, and commercialising Envafolimab in these areas.

As per the statement 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.

It will be Jiangsu Alphamab’s responsibility to manufacture KN035, and they 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," said Glenmark Pharmaceuticals Chairman and Managing Glenn Saldanha.

"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,” he added.

Envafolimab, under the brand name ENWEIDA, was approved in China by the National Medical Products Administration in November 2021 for treating adult patients with certain types of advanced solid tumours. It has also been officially included in the "List of Breakthrough Therapies" by the NMPA, the company statement reads.

Currently, Envafolimab is being developed in the USA by Tracon Pharma in a significant trial in soft tissue sarcoma subtypes.

The drug has obtained two orphan drug designations 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.