• CStone eligible to receive up to US$192.5 million in upfront, regulatory, and commercial milestone payments
• CStone to recognize close to 50% of net sales in the licensed territories as revenue
• Regulatory approval of sugemalimab secured in the EU, European Economic Area (EEA) countries, and the United Kingdom (UK) for metastatic squamous and non-squamous NSCLC; additional applications in progress
• Partnership expands sugemalimab's global reach to over 60 countries and regions
Suzhou, China, July 8, 2025—CStone Pharmaceuticals (“CStone,” HKEX: 2616), an innovation-driven biopharmaceutical company focused on oncology, today announced an exclusive partnership with Istituto Gentili (“Gentili”), a leading European biopharmaceutical company with a century-long heritage in oncology, to commercialize sugemalimab across Western Europe and the UK.
Under the terms of the agreement, Gentili will receive exclusive commercialization rights for sugemalimab in 23 European countries—including 18 EEA countries (Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece , Ireland, Italy, Liechtenstein, Luxembourg, Malta, the Netherlands, Norway, Portugal, Spain, and Sweden)—as well as the United Kingdom, Andorra, Monaco, San Marino, and Vatican City.
CStone is eligible to receive up to US$192.5 million in total consideration, comprising an upfront payment and payments tied to regulatory and commercial milestones. Additionally, CStone will supply sugemalimab and recognize close to 50% of net sales from the licensed territories as revenue, while Gentili will lead all local regulatory and commercial operations in the covered regions.
Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, stated:
“Sugemalimab is the first anti-PD-L1 monoclonal antibody approved in the EU and UK for use in combination with chemotherapy for the first-line treatment of stage IV non-small cell lung cancer (NSCLC), regardless of histology or PD-L1 expression. The European Medicines Agency (EMA) has also accepted a supplemental marketing application for Stage III NSCLC, which, if approved, will make sugemalimab the second PD-(L)1 therapy in Europe for this indication.
Gentili’s deep oncology expertise, established commercial infrastructure, and commitment to patient-centric innovation make them an ideal partner to accelerate access to sugemalimab across Europe, especially during this critical time, as the ongoing dynamic pricing discussions in the US create uncertainty around the global availability and affordability of US market-weighted immunotherapy drugs. Therefore, it is more critical than ever to broaden access to high-impact therapies like sugemalimab.
To date, we have secured four major regional partnerships covering more than 60 countries and territories across Europe, the Middle East, Africa, and Latin America. Our global commercialization launch is underway, and we are working closely with our partners to integrate resources and maximize both the clinical and commercial value of sugemalimab. Meanwhile, we continue to pursue new collaborations in Southeast Asia, Canada, and other key markets, while advancing regulatory filings for additional indications.”
Alessandro Del Bono, CEO of Istituto Gentili, commented:
“At Gentili, we are committed to transforming oncology care by delivering innovative, high-quality treatments to patients. We are proud to partner with CStone to introduce sugemalimab—a well clinically validated innovative immunotherapy—to patients across Europe and the UK. Its compelling clinical profile in stage IV NSCLC and potential future indication in stage III disease will help address significant unmet needs in the region.
Sugemalimab is highly complementary to our current pipeline and strategic focus. Through this collaboration, we aim to accelerate patient access by establishing a robust and efficient commercialization pathway. Together with CStone, we look forward to driving therapeutic innovation and improving outcomes for patients across our markets. This agreement is another important step in our development strategy aimed at extending our pipeline in oncology and expanding Gentili’s presence in Europe.”
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.
The European Commission (EC) and the Medicines and Healthcare products Regulatory Agency (MHRA) have approved sugemalimab 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. In March 2025, a Type II variation application has been submitted to the EMA for sugemalimab. The application seeks approval for the treatment of patients with unresectable stage III NSCLC who have not progressed following concurrent or sequential platinum-based chemoradiotherapy.
The National Medical Products Administration (NMPA) of China has approved sugemalimab for five indications:
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 16 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 .
IR contact: ir@cstonepharma.com
PR contact: pr@cstonepharma.com
About Istituto Gentili
Istituto Gentili, part of Mediolanum Farmaceutici Group, is an a European biopharmaceutical company headquartered in Milan, with over a century of history and expertise in the development and commercialization of innovative molecules - both proprietary and in partnership, in the fields of oncology and oncohaematology, rare diseases, pain therapy and supportive care. The exclusive commitment to oncology has enabled the company to have an articulated product portfolio including targeted therapies to treat patients with HER2+ and HER2- metastatic breast cancer, advanced renal cell carcinoma, non-Hodgkin lymphoma, acute myeloid leukemia, soft tissue sarcomas and neuroendocrine tumors, along with pain therapy and supportive care to prevent or improve conditions associated with the oncological disease.
For more information about Istituto Gentili, please visit https://gentilipharma.com/ or follow the company on LinkedIn.
PR contact: o.landi@istitutogentili.com
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