Ewopharma and CStone enter into a Strategic Partnership for Sugemalimab in Central Eastern Europe and Switzerland

Under the agreement, Ewopharma will gain the commercial rights for sugemalimab in Switzerland and 18 Central Eastern European countries (CEE). These include 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, Serbia.

• The partnership will maximize the value of sugemalimab (anti-PD-L1 monoclonal antibody) in Central Eastern Europe and Switzerland.
• CStone will receive up to $51.3 million in upfront payment and additional considerations payable upon the achievement of certain regulatory and sales milestones.
• CStone will book international revenues via the sale of supply to Ewopharma.
• The European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) are reviewing the marketing authorization application (MAA) for sugemalimab in combination with chemotherapy as the first-line treatment of metastatic nonsmall cell lung cancer.

Under the terms of the 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.

Dr. Jason Yang, CEO and President of R&D at CStone, said: “As a potentially best-in-class anti-PD-L1 monoclonal antibody, sugemalimab has demonstrated remarkable efficacy in multiple clinical trials and has already been approved in China for five indications, covering stage III and IV NSCLC, gastric cancer, esophageal squamous carcinoma, and extranodal NK/T-cell lymphoma. In European markets, we look forward to receiving MAA approval from the European Medicines Agency in the near future. We believe sugemalimab has a broad application prospect in Europe and global markets. Ewopharma is a reliable pharmaceutical marketing partner with abundant experience and extensive channels in CEE markets. The collaboration will undoubtedly help sugemalimab maximize its clinical and commercial value and benefit more patients in Europe. We look forward to taking a firm step toward the international commercialization of sugemalimab with Ewopharma.”

Alain Staub, CEO and Chairman of the Board of Ewopharma adds: “We are delighted to enter into this strategic partnership with CStone. Sugemalimab is an innovative treatment further expanding our oncology franchise and allows us to make an important contribution to health equity in our region.

According to Globocan 2022, lung cancer is the third most common cancer in Europe and the leading cause of cancer-related deaths, accounting for one-fifth of all cancer deaths. Sugemalimab will improve the treatment landscape for patients with advanced non-small cell lung cancer. We are very happy to be able to bring hope and optimism to patients and healthcare professionals alike.”

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.

About Ewopharma AG

Ewopharma AG, headquartered in Schaffhausen (Switzerland), is a pharmaceutical marketing company focused on Central Eastern Europe and Switzerland. With more than 60 years presence in the region, Ewopharma has extensive knowledge of these markets and enjoys a privileged position in the area. The company covers all aspects of market access and commercialization of ethical pharmaceutical and consumer health products. Further information is available at www.ewopharma.com.

About CStone

CStone (HKEX: 2616), established in late 2015, is an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies. Dedicated to addressing patients’ unmet medical needs in China and globally, the company has made significant strides since its inception.

To date, the company has successfully launched four innovative drugs and secured approvals for 14 new drug applications (NDAs) covering 9 indications. The company’s pipeline is balanced by 12 promising candidates, featuring potentially first-in-class or best-in-class antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies and precision medicines. CStone also prides itself on a management team with comprehensive experiences and capabilities that span the entire drug development spectrum, from preclinical and translational research to clinical development, drug manufacturing, business development, and commercialization. For more information about CStone, please visit www.cstonepharma.com.

PR contact: pr@cstonepharma.com
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