On January 25, 2024 Alphamab Oncology (stock code: 9966.HK) and 3DMedicines (stock code: 1244.HK) ("Licensors") reported that we entered into a license agreement with Glenmark Specialty S.A. (GSSA), a subsidiary of Glenmark Pharmaceuticals Ltd. (BSE: 532296，NSE: GLENMARK) for the subcutaneous injection PD-L1 antibody drug (R&D code: KN035, generic name: Envafolimab), pursuant to which, Glenmark was granted exclusive licensing interests in clinical development and commercialization of oncology indications in India, Asia Pacific(except Singapore, Thailand, Malaysia), the Middle East and Africa, Russia, CIS and Latin America. Glenmark will develop and commercialize KN035 in the Field in the Territory at its own cost and expense.
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Under the License Agreement, Licensors will receive from GSSA (a) a total of up to US$700.8 million of a non-refundable upfront payment and milestones payments subject to the achievement of certain development, regulatory and commercialization milestones, and (b) a single to double digits percentage royalty fee according to the level of net sales of KN035. The Licensors’ respective entitlement to the payments (including the upfront payment, milestone payment and the royalty fees) under the License Agreement are subject to the agreements between Jiangsu Alphamab and 3D Medicines.Jiangsu Alphamab retains its sole right to manufacture KN035 for any purpose within or outside the Territory. 3D Medicines retains the right to develop and commercialize KN035 for any purpose in the field of tumor outside the Territory.
We believe that the cooperation will enable Jiangsu Alphamab to effectively utilize the existing team and resources of Glenmark and establish a favorable market position for KN035 in the Territory rapidly. The implementation of the License Agreement will have a positive impact on the commercialization of KN035 in the Territory.
Dr. Ting Xu, Chairman, and CEO of Alphamab Oncology, remarked, "This collaboration holds significant importance for the continued advancement of Envafolimab. Leveraging Glenmark’s robust development and commercialization capabilities, we are confident that Envafolimab will reach a substantial number of patients in the specified territory, especially in regions where cancer patients face underserved conditions. The notable advantages of Envafolimab in terms of safety, convenience, and compliance position it as a competitive product. We eagerly anticipate a successful collaboration."
Dr. Gong Zhaolong, Chairman and CEO of 3D Medicines, remarked, "We are very pleased that Envolizumab can help more cancer patients. This cooperation is good news for more cancer patients. In a wide range of emerging markets, patients need more convenient and innovative treatments. We will work together to serve more cancer patients and help them live longer and better."
"This marks an important milestone for us at Glenmark, through this transformational deal we get access to the first recombinant humanized single domain antibody against PD-L1 in a SubQ formulation for a wide territory globally. We are excited to take this innovative product across our territory and meaningfully contribute to the spread of immune Oncology treatments to potentially help cancer patients across emerging markets." remarked Glenn Saldanha, Chairman & Managing Director Glenmark Pharmaceuticals Ltd.
About Envafolimab（KN035）
Envafolimab is a single domain Fc fusion PD-L1 antibody independently invented by Alphamab Oncology，and co-developed with 3D (Beijing) Medicines since 2016. On March 30, 2020, Alphamab Oncology, 3DMed, and Simcere reached a strategic cooperation, whereby Alphamab Oncology is responsible for production and quality control, and 3DMed is responsible for the clinical development in oncology field, and Simcere is responsible for the exclusive commercial promotion of products in mainland China.
Based on its unique design that allows rapid subcutaneous injection, it has advantages of improved safety, convenience in drug administration, and treatment compliance. Patients do not require an intravenous infusion which lowers medical costs. At present, Envafolimab is being studied in clinical trials in multiple tumor types in China, the United States and Japan, including registration/phase III clinical trials in multiple indications. Envafolimab obtained orphan drug designation from the US FDA for the treatment of advanced biliary tract cancer and soft tissue sarcoma. In November 2021, Envafolimab obtained the market approval by the Chinese National Medical Products Administration for the treatment of MSI-H or dMMR advanced solid tumors, including those patients with advanced colorectal cancer who have experienced disease progression following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens as well as patients with other advanced solid tumors who have experienced disease progression following prior treatment and have no satisfactory alternative treatment options.
(Press release, Alphamab, JAN 25, 2024, View Source [SID1234657017])