CStone Pharmaceuticals (“CStone”, HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, announced on May 27th 2024, that CStone has entered into a strategic commercial collaboration with the European pharmaceutical company Ewopharma. Under the licensing and commercialization agreement, Ewopharma will gain the commercial rights for sugemalimab in Switzerland and 18 Central Eastern European countries (CEE). This includes EU member countries Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia, and Slovenia, as well as non-EU countries Albania, Bosnia & Herzegovina, Kosovo, North Macedonia, Moldova, Montenegro, and Serbia. Fangda Partners acted as legal counsel to CStone through the transaction.
Under the terms of the licensing and commercialization agreement, CStone will receive up to $51.3 million in upfront payment and additional considerations payable upon the achievement of certain regulatory and sales milestones. In addition, CStone will book revenues from sales of supply to Ewopharma and its affiliates. Ewopharma will be in charge of pricing, reimbursement, sales & marketing, and distribution, whilst CStone will be responsible for product supply and provide necessary training and support for the brand.
Sugemalimab, an anti-PD-L1 monoclonal antibody developed by CStone, has been granted approvals in China for all five indications that entered late-stage clinical trials, including stage III and IV NSCLC, extranodal NK/T-cell lymphoma, esophageal squamous carcinoma, and gastric cancer. EMA and UK MHRA are reviewing the MAA for sugemalimab in combination with chemotherapy as the first-line treatment of metastatic NSCLC.
The clinical data of sugemalimab have been presented at various international academic conferences and published in top-tier journals such as The Lancet Oncology, Nature Medicine, Nature Cancer, and Journal of Clinical Oncology. CStone is also in discussions with regulatory authorities including EMA, UK MHRA, and US Food and Drug Administration (FDA) for other indications of sugemalimab and actively expanding partnerships for development and commercialization in other regions worldwide. Fangda acted as legal counsel to CStone in the transaction and provided comprehensive legal services.
The Fangda team was led by Corporate partners Josh Shin and Henry He in transaction structures design, transaction documents negotiation and amendment. Team members included counsel Bella Wang, associates Audrey Luo and Essie Zhao.
