CStone will receive upfront, regulatory and commercial milestone payments, and book revenue from SteinCares through the supply of sugemalimab in 10 Latin American (LATAM) countries.
This marks CStone's third major global commercialization partnership for sugemalimab, with additional deals in Western Europe, Southeast Asia, Canada, and other regions anticipated soon. CStone has received marketing approval for sugemalimab in the EU, EEA countries (Iceland, Liechtenstein, and Norway), and the UK, while actively advancing regulatory submissions for additional indications.
SUZHOU, China, Jan. 26, 2025 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, today announced a strategic commercialization partnership with SteinCares, a leading pharmaceutical company with over 40 years of experience anda strong presence in Latin America. Under this agreement, SteinCares will gain the commercialization rights for sugemalimab in 10 LATAM countries, including Brazil, Argentina, Mexico, Chile, Colombia, Costa Rica, Panama, Peru, Guatemala and Ecuador.
As part of this collaboration, SteinCares will be responsible for the regulatory affairs and commercialization activities of sugemalimab in these regions. CStone will supply sugemalimab and will 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.
We are also actively discussing with international partners in Western Europe, Southeast Asia, and Canada, while advancing regulatory submissions for additional indications of sugemalimab. We are confident that these efforts will further unlock the therapeutic and commercial potential of sugemalimab, ultimately benefiting patients worldwide."
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."
About Sugemalimab
The anti-PD-L1 monoclonal antibody sugemalimab was developed by CStone using OmniRat® transgenic animal platform, which allows creation of fully human antibodies in one step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody, which may reduce the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs. Sugemalimab's differentiated molecular design enables a dual mechanism of action that not only blocks PD-1/PD-L1 interaction, but also induces 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:
In combination with chemotherapy as first-line treatment of patients with metastatic squamous and non-squamous NSCLC;
For the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy;
For the treatment of patients with relapsed or refractory extranodal NK/T-cell lymphoma;
In combination with fluorouracil and platinum-based chemotherapy as first-line treatment of patients with unresectable locally advanced, recurrent or metastatic ESCC; and
In combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with a PD-L1 expression (Combined Positive Score [CPS] ≥5).
The European Commission (EC) has approved sugemalimab (brand name: Cejemly®) 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 tumor aberrations.
The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has approved the marketing authorization application for sugemalimab in combination with platinum-based chemotherapy for first-line treatment of metastatic NSCLC with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations.
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 4 innovative drugs and secured approvals for 16 new drug applications (NDAs) covering 9 indications. The company's pipeline is balanced by 17 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.
SteinCares is a leader in commercializing and distributing specialty healthcare products in Latin America, including innovative pharmaceuticals, biosimilars, plasma-derived therapies and complex generics. With more than 40 years of progressive healthcare experience and operations in over 30 countries in Latin America and the Caribbean, SteinCares serves as a bridge between global pharmaceutical companies and the region's healthcare providers. The company is deeply committed to creating healthcare opportunities that positively impact the lives of patients and their families in Latin America, with a vision of increasing access to innovative and cost-effective healthcare for patients in the region.
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