CStone and SteinCares: A Strategic Partnership to Unlock Sugemalimab's Potential in Latin America

CStone Pharmaceuticals ("CStone", HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, has announced a strategic commercialization partnership with SteinCares, a leading pharmaceutical company with over 40 years of experience and a strong presence in Latin America. This collaboration marks a significant milestone in CStone's global expansion strategy for sugemalimab, its flagship anti-PD-L1 monoclonal antibody.

Under the agreement, SteinCares will gain the commercialization rights for sugemalimab in 10 Latin American (LATAM) countries, including Brazil, Argentina, Mexico, Chile, Colombia, Costa Rica, Panama, Peru, Guatemala, and Ecuador. SteinCares will be responsible for the regulatory affairs and commercialization activities of sugemalimab in these regions, while CStone will supply the drug and receive upfront, regulatory, and commercial milestone payments, as well as revenue from product supply.

Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, stated, "Following our successful market entries in Central and Eastern Europe, Switzerland, as well as the Middle East and Africa, we are excited to announce another key milestone in the global expansion of sugemalimab. As the first anti-PD-L1 monoclonal antibody approved in both the EU and UK for first-line, all-comer, Stage IV non-small cell lung cancer (NSCLC), sugemalimab is well-positioned for success in Latin America. SteinCares' extensive distribution network and deep marketing expertise will significantly enhance sugemalimab's reach."

Mitchell Waserstein, CEO of SteinCares, added: "This agreement with CStone represents a significant step forward in our mission to create healthcare opportunities for patients in LATAM. At SteinCares, we are committed to providing more Latin Americans with greater access to safe, innovative, and affordable therapies. With our extensive experience and established sales network across the region, we are confident in our ability to successfully commercialize sugemalimab in LATAM and make a meaningful impact on patients' health and well-being."

Sugemalimab, developed by CStone using the OmniRat® transgenic animal platform, is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody. Its unique molecular design enables a dual mechanism of action, blocking PD-1/PD-L1 interaction and inducing antibody-dependent cellular phagocytosis (ADCP) by cross-linking PD-L1-expressing tumor cells with tumor-associated macrophages (TAMs) without harming Effector T-cells. This differentiation has resulted in competitive efficacy/safety across a variety of tumor types.

The National Medical Products Administration (NMPA) of China has approved sugemalimab for five indications, while the European Commission (EC) has approved it in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC with no sensitizing EGFR mutations, or ALK, ROS1, or RET genomic alterations.

CStone has received marketing approval for sugemalimab in the European Union (EU), European Economic Area (EEA) countries (Iceland, Liechtenstein, and Norway), as well as the United Kingdom (UK), and is actively advancing regulatory submissions for additional indications. The company has also entered into strategic commercialization partnerships with Ewopharma and Pharmalink, further expanding sugemalimab's global footprint.

In conclusion, the strategic partnership between CStone and SteinCares is a significant step forward in unlocking sugemalimab's potential in the Latin American market. With SteinCares' extensive distribution network and marketing expertise, sugemalimab is poised to reach a broader range of patients, ultimately benefiting the region's healthcare landscape. As CStone continues to expand sugemalimab's global presence, investors can expect the company to generate additional revenue streams and create value for shareholders.