On January 27, 2025 CStone Pharmaceuticals (stock code: 2616.HK), an innovation-driven biopharmaceutical company focused on developing oncology drugs, reported a strategic commercialization collaboration with SteinCares, a leading pharmaceutical company with deep expertise in the Latin American market (Press release, CStone Pharmaceauticals, JAN 27, 2025, View Source [SID1234656222]). Under the license and commercialization agreement, SteinCares will acquire the commercialization rights to sugemalimab in ten countries across Latin America: Brazil, Argentina, Mexico, Chile, Colombia, Costa Rica, Panama, Peru, Guatemala, and Ecuador.
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In the collaboration between the two parties, SteinCares will be responsible for the registration and commercialization-related activities of Sugemalimab in the above-mentioned regions, while CStone Pharmaceuticals will be responsible for the product supply of Sugemalimab and will receive an upfront payment, registration and sales milestone payments from SteinCares, as well as international revenue from the sales of Sugemalimab to SteinCares.
Dr. Jianxin Yang, CEO, President of R&D, and Executive Director of CStone Pharmaceuticals, said, "Following the successful expansion into dozens of countries across Switzerland, Central and Eastern Europe, the Middle East, and Africa, sugemalimab has achieved another breakthrough in global commercialization. Sugemalimab is the first PD-L1 monoclonal antibody approved in the EU and the UK for the first-line treatment of all patients with Stage IV non-small cell lung cancer . Combined with SteinCares’ extensive distribution network and extensive service experience throughout Latin America, we will expand sales channels for sugemalimab in multiple Latin American regions."
At the same time, we are promoting international collaborations in Western Europe, Southeast Asia, and Canada, and actively advancing the registration and marketing of sugemalimab for other indications. We believe that with the progress of overseas registration applications and international commercialization collaborations, sugemalimab will further demonstrate its intended application and commercial value. We also look forward to collaborating with more international partners to benefit more patients worldwide."
Mitchell Waserstein, CEO of SteinCares, said: "This collaboration is a significant step forward in our efforts to create access to safe, innovative and affordable treatments for patients in Latin America. We are committed to helping patients access safe, innovative and affordable treatment options. Leveraging our decades of experience and established sales network in Latin America, we are confident we can develop a viable and efficient commercialization path for sugemalimab to address the unmet medical needs of patients in the region."
About Sugemalimab
Sugemalimab was developed by CStone Pharmaceuticals using the OmniRat transgenic animal platform licensed from Ligand Corporation in the United States . This platform enables the one-stop production of fully human antibodies. As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab is the closest to the body’s natural G-type immunoglobulin 4 (IgG4) response, minimizing the potential for immunogenicity and related toxicities in patients, offering distinct advantages over similar agents. Sugemalimab’s unique molecular design equips it with a dual mechanism of action: it not only blocks the PD-1/PD-L1 interaction but also mediates the interaction between PD-L1-positive tumor cells and tumor-associated macrophages (TAMs), inducing antibody-dependent cellular phagocytosis (ADCP) while sparing effector T cells. This differentiated design has enabled sugemalimab to demonstrate competitive efficacy and safety across various tumor types.
Currently, the China National Medical Products Administration (NMPA) has approved five indications for Sugemalimab (trade name: Zegemet) :
First-line treatment in combination with chemotherapy for patients with metastatic squamous and non-squamous NSCLC;
For the treatment of patients with unresectable, stage III NSCLC who have not experienced disease progression after concurrent or sequential chemoradiotherapy;
Treatment of patients with relapsed or refractory extranodal NK/T-cell lymphoma;
Combined with fluorouracil and platinum chemotherapy drugs as the first-line treatment for patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma;
In combination with fluorouracil-containing and platinum-based chemotherapy, it is used for the first-line treatment of unresectable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma that expresses PD-L1 (combined positive score [CPS] ≥ 5).
The European Commission (EC) has approved sugemalimab (trade name: Cejemly ) in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC who do not have EGFR-sensitive mutations or genomic tumor alterations in ALK, ROS1, or RET.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved sugemalimab in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC who do not have EGFR-sensitive mutations or genomic tumor alterations in ALK, ROS1, or RET.