CSTONE partners with Steincares on the Sugemalimab market in Latin America by ulaganjem.com

• CSTONE will receive an upfront, regulatory and commercial milestone and booked revenue from Steincares through the supply of Sugemalimab in 10 Latin American (LATAM) countries.
• This marks Cstone’s third major global commercialization partnership for Sugemalimabwith additional offers in Western Europe,, Southeast Asia,, Canadaand other regions were expected soon. CSTONE received approval for sugemalimab in EEA countries (Iceland,, Liechtensteinand Norway), i UKwhile regulatory applications for additional indications are actively progressing.

Suzhou, China,, January 26, 2025 /prnewswire/ – CSTONE PHARMACEUTICALS (“CSTONE”, HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of cancer therapies, today announced a strategic commercialization partnership with Steinkares, a leading pharmaceutical company with over 40 years of experience and strong presence in Latin America. Under this agreement, Steincares will acquire 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 of Sugemalimab in these regions. Cstone will supply Sugemalimab and will receive upfront, regulatory and commercial milestone payments, as well as product supply revenue.

dr. Jason YangCEO, President of R&D and CEO at Cstone, stated: “Following our successful market entries in Central and Eastern Europe,, Switzerlandas well as Middle East and AfricaWe are excited to announce another key milestone in Sugemalimab’s global expansion. As the first anti-pd-l1 monoclonal antibody approved in the EU and UK For the first line, All-COMER, Stage IV. Lung cancer (NSCLC), cells) cells IV.sugemalimab is well positioned for success in Latin America. STEINCARES’ extensive distribution network and deep marketing expertise will significantly enhance the reach of Sugemalimab.

We are also actively talking with international partners in Western Europe,, Southeast Asiaand Canadawhile regulatory applications for additional indications of sugemalimab are progressing. We are confident that these efforts will further unlock the therapeutic and commercial potential of Sugemalimab, ultimately benefiting patients worldwide. “

Mitchell WeresteinCEO of Steincares, added: “This agreement with CSTONE represents a significant step forward in our mission to create healthcare opportunities for patients in Latham. At Steincares, we are committed to providing more Latin American women with greater access to safe, innovative and affordable therapy.

About Sugemalimab

The anti-PD-L1 monoclonal antibody sugemalimab was developed by Cstone using the Omnirat ® transgenic animal platform, which enables the generation of fully human antibodies in one step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) 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-L1 expressing tumor cells with tumor-associated macrophages (TAMS) without harm effector T-cells. This differentiation resulted in competitive efficacy/safety in different tumor types.

National Medical (TASE 🙂 Product administration (NMPA) of China approved sugemalimab for five indications:

• In combination with chemotherapy as the first 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 after 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 for 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 PD-L1 expression (combined positive result [CPS] ‰ ¥ 5).

AND European Commission (EC) approved SugemalimaB (brand name: CeJemly ® ) in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC without sensitizing EGFR or ALK, ROS1, or RET genomic tumor mutations.

Medicines and Healthcare products Regulatory Agency (MHRA) in United Kingdom (Tadawul 🙂 approved a marketing authorization application for sugemalimab in combination with platinum-based chemotherapy for the first-line treatment of metastatic NSCLC without sensitizing EGFR mutations, or ALK, ROS1, or RET genomic tumor aberrations.

O CMSTON

Cstone (HKEX: 2616), founded in late 2015, is an innovation-driven biopharmaceutical company focused on the research and development of cancer therapies. Dedicated to solving the unsatisfied medical needs of patients 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 with 17 promising candidates, representing potential antibody-antibody and best-in-class conjugates (ADCs), multispecific antibodies, immunotherapies and precision medicine. Cstone also boasts a management team with comprehensive experience and capabilities spanning the entire spectrum of drug development, from preclinical and translational research to clinical development, drug manufacturing, business development and commercialization. For more information about Cstone, visit www.cstonepharma.com.

IR Contact: ir@cstonepharma.com
PR Contact: pr@cstonepharma.com

About Steincares

Steincares is a leader in the commercialization and distribution of special health products in Latin Americaincluding innovative medicines, biosimilars, plasma-derived therapies and compounded generics. With more than 40 years of progressive healthcare experience and operations in over 30 countries in Latin America AND CaribbeanSteincares serves as a bridge between global pharmaceutical companies and healthcare providers in the region. The company is deeply committed to creating health care options that positively impact the lives of patients and their families in Latin Americawith the vision of increasing access to innovative and economical health care for patients in the region.

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

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