Jiangsu Alphamab Biopharmaceuticals, 3D Medicines (Beijing), and Glenmark have signed a License Agreement for KN035 (Envafolimab) to be Distributed Globally

Glenmark Specialty Sa a subsidiary of Glenmark Pharmaceuticals Ltd., recently inked a license agreement with JIANGSU ALPHAMAB BIOPHARMACEUTICALS CO., LTD (Jiangsu Alphamab) and 3D MEDICINES (BEIJING) CO., LTD. (3DMed), collectively referred to as the Licensors. This agreement grants GSSA an exclusive license for the development, registration, and commercialization of Envafolimab (KN035) for oncology indications in specific regions, including India, Asia Pacific, Middle East, Africa, Russia, CIS, and Latin America.

As per the agreement terms, Jiangsu Alphamab will serve as the exclusive supplier of Envafolimab, and GSSA will make payments, including a low double-digit Million US Dollar amount before the product launch, additional triple-digit Million US Dollar milestone payments based on sales performance, and a royalty fee tied to net sales, ranging from single to double digits.

Glenn Saldanha, Chairman & Managing Director of Glenmark Pharmaceuticals Ltd., expressed excitement about this transformative deal, emphasizing the significance of gaining access to the first recombinant humanized single domain antibody against PD-L1 in a Sub-Q formulation for a broad global territory. He underlined the company's commitment to bringing this innovative immuno-oncology product, known as ENWEIDA (Envafolimab), to cancer patients in emerging markets.

Envafolimab has already received approval in China as a subcutaneous injection PD-L1 inhibitor for treating adult patients with previously treated microsatellite instability-high (MSI-H) or deficient MisMatch repair (dMMR) advanced solid tumors. With its potential to effectively treat a significant population of cancer patients with dMMR, Envafolimab is expected to make a meaningful impact in emerging markets and beyond.

Notably, Envafolimab is undergoing development in the USA by Tracon Pharma for soft tissue sarcoma (STS) subtypes, including Undifferentiated Pleomorphic Sarcoma (UPS) and myxofibrosarcoma (MFS). The drug has received orphan drug designations for advanced biliary tract cancer and STS from the U.S. FDA and a Fast Track designation for STS. Additional indications, such as Biliary Tract cancer and non-small cell lung cancer, are currently in the developmental pipeline.

KN035 (Envafolimab Injectable) is a recombinant single domain antibody against PD-L1 fused with human Fc. Developed by Alphamab Oncology and co-developed with 3DMed Beijing since 2016, it holds promise as an innovative therapeutic option for various oncology indications. The licensing agreement marks a significant step in expanding access to this groundbreaking treatment across diverse global regions.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!