Cstone works with Steincares to market Sugemalimab in Latin America. From investing.com

• CSTONE receives advance payments, regulatory and commercial milestone payments as well as book revenue from Steinkares through the delivery of Sugemalimab to 10 Latin American (Latam) countries.
• This is the third large global commercialization partnership from CSTONE for SugemalimabWith additional offers in Western Europe,, Southeast Asia,, CanadaAnd other regions will soon be expected. CSTONE has received market approval for Sugemalimab in the EU and the EEA countries (Iceland,, LiechtensteinAnd Norway) and the United Kingdomwhile at the same time the registration applications for additional indications are actively promoted.

Suzhou, China,, January 26, 2025 / Prnewswire/ — Cstone Pharmaceuticals (“CSTONE”, HKEX: 2616), an innovation -driven biopharmaceutical company that focuses on the research and development of cancer therapies, today announced a strategic commercialization partnership Steincares, a leading pharmaceutical company with over 40 years of experience and A strong presence in Latin America. As part of this agreement, Steincares receives the marketing rights for Sugemalimab in 10 Latin American countries, including Brazil,, Argentina,, Mexico,, Chile,, Colombia,, Costa Rica,, Panama,, Peru,, Guatemala And Ecuador.

As part of this cooperation, Steincares will be responsible for the regulatory matters and marketing activities of Sugemalimab in these regions. CSTONE will deliver Sugemalimab and receives advance payments, official and commercial milestone payments as well as income from product delivery.

Dr. Jason YangCEO, President of Research and Development and Executive Director at Cstone, said: “After our successful market in Central and Eastern Europe,, Switzerlandas well as the Middle East And AfricaWe are pleased to announce another important milestone in the global expansion of Sugemalimab. The first monoclonal anti-PD-L1 antibody approved in the EU United Kingdom For all-comer first-line therapy for non-small cell lung cancer in stage IV (NSCLC)Sugemalimab is well positioned for success Latin America. The extensive sales network and the extensive marketing expertise of Steinkares will significantly increase the range of Sugemalimab.

We also actively discuss with international partners in Western Europe,, Southeast AsiaAnd CanadaWhile admission applications for additional indications of Sugemalimab are also promoted. We are confident that these efforts will continue to open up the therapeutic and commercial potential of Sugemalimab and ultimately benefit patients worldwide. ”

Mitchell WasersteinCEO von Steinkares added: “This agreement with CSTONE represents a significant step forward in our mission to create health care for patients in Latam. At Steinkares, we are committed to giving more Latin Americans better access to safe, innovative and affordable care. “” With our extensive experience and our established sales network in the entire region, we are confident that we successfully market Sugemalimab in Latin America and one significant influence on the health and well -being of the patients. ”

About Sugemalimab

The monoclonal anti-PD-L1 antibody Sugemalimab was developed by CSTONE using the transgenic animal platform Omnirat®, which enables the production of completely human antibodies in one step. Sugemalimab is a completely human monoclonal anti-PD-L1 immunoglobulin G4 (IGG4) antibody full of length that can reduce the risk of immunogenicity and toxicity for patients-a unique advantage over similar drugs. The differentiated molecular design of Sugemalimab enables a double mechanism of action that not only blocks PD-1/PD-L1 interaction, but also induces antibody-dependent cellular phagocytosis (ADCP) by pd-l1-expressioned tumor cells with tumor-associated macrophages (tams) be networked. without damage to Effector T cells. This differentiation has led to competing effectiveness/security with a variety of tumor species.

The national Medical (TASE 🙂 Product management (NMPA) of China Sugemalimab approved for five indications:

• In combination with chemotherapy as a first-line treatment of patients with metastatic squamous epithelial carcinoma and non-record-epithelial carcinoma NSCLC;
• For treating patients with inoperable NSCLC in stage III, whose illness has not advanced after simultaneous or sequential platinum -based radiochemotherapy;
• To treat patients with recurrent or refractory extranodal nk/t cell lymphoma;
• In combination with fluorouracil and platinum -based chemotherapy as an initial treatment of patients with inoperable, locally advanced, recurrent or metastatic ESCC; And
• In combination with fluoropyrimidine and platinum-containing chemotherapy as an initial treatment for inoperable, locally advanced or metastatic adenocarcinoma of the gastrointestinal or gastroesophageal transition (g/G/GEJ) with a PD-L1 expression (combined positive score (CPS) ¥ 5) .

The European Commission (EC) has approved Sugemalimab (brand name: CEJEMLY ®) in combination with a platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC without sensitizing EGFR mutations or genomic tumorabrations of ALK, ROS1 or RET.

The regulatory authority for medicines and health products (MHRA) in the United kingdom (Tadawul 🙂 has approved the application for admission for Sugemalimab in combination with platinum-based chemotherapy for first-line treatment for metastatic NSCLC without sensitizing EGFR mutations or alk, Ros1 or RET genome tumora.

About Cstone

CSTONE (HKEX: 2616) was founded at the end of 2015 and is an innovation -driven biopharmaceutical company that focuses on the research and development of cancer therapies. We devote ourselves to the solution of uncovered medical needs of patients China And the company has made significant progress worldwide since its foundation. To date, the company has successfully launched four innovative medication and received approval for 16 new drug applications (NDAS) for nine indications. The company’s pipeline comprises 17 promising candidates, including potentially first-class or first-class antibody-active ingredients (ADCS), multi-specific antibodies, immunotherapies and precision medications. CSTONE is also proud of a management team with comprehensive experiences and skills that covers the entire spectrum of drug development, from preclinical and translational research to clinical development, drug production, business development and commercialization. For more information about Cstone, see www.cstonepharma.com.

Ir-contact: ir@cstonepharma.com
PR contact: pr@cstonepharma.com

About Steincares

Steinkares is a leader in the commercialization and distribution of special products for health care Latin AmericaIncluding innovative medicines, biosimilars, therapies obtained from plasma and complex generics. With more than 40 years of experience in the progressive healthcare system and branches in over 30 countries Latin America and the CaribbeanSteinkares serves as a bridge between global pharmaceutical companies and the region’s health service providers. The company is intensively committed to creating health opportunities that have a positive effect on the life of patients and their families Latin Americawith the vision of improving access to innovative and cost -effective health care for patients in the region.

For more information, see http://www.steincares.com/ or follow the company LinkedIn.

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