On July 8, 2025 CStone Pharmaceuticals (stock code: 2616.HK), an innovation-driven biopharmaceutical company focused on the research and development of oncology drugs, reported an exclusive strategic collaboration with Istituto Gentili ("Gentili"), a biopharmaceutical company focused on oncology with a century-long history in the European market, for the commercialization of sugemalimab in Western Europe and the United Kingdom (Press release, CStone Pharmaceauticals, JUL 8, 2025, View Source [SID1234656252]).
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Under the terms of the agreement, Gentili will obtain exclusive commercialization rights for sugemalimab in 23 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 the Vatican.
CStone Pharmaceuticals will receive an upfront payment, regulatory and sales milestone payments from Gentili, with the total transaction value reaching up to US$192.5 million . By supplying Gentili, CStone will also receive approximately 50% of net sales of sugemalimab in the licensed territory . Gentili will be responsible for regulatory and commercial activities for sugemalimab in these territories.
Dr. Jianxin Yang, CEO, President of R&D, and Executive Director of CStone Pharmaceuticals, said: "Sugemalimab is the first PD-L1 monoclonal antibody approved in the EU and UK for the first-line combination treatment of stage IV non-small cell lung cancer (NSCLC) in all patients (regardless of histological type or PD-L1 expression level) in combination with chemotherapy. Our new indication application for stage III NSCLC has also been accepted by the European Medicines Agency (EMA). If approved, sugemalimab will become the second PD-(L)1 antibody for this indication in Europe.
With its deep expertise in oncology, mature commercialization system, and patient-centric innovation, Gentili is an ideal partner to accelerate the accessibility of Sugemalimab in the European market. Immunotherapies, currently priced based on US market standards, are facing new uncertainties in their global supply and payment models due to the controversy surrounding the US drug pricing system reform. Against this backdrop, expanding access to clinically significant therapies like Sugemalimab has become a top priority for the global healthcare community.
To date, we have reached four major commercialization collaborations for Sugemalimab in Europe, the Middle East and Africa, and Latin America, covering a total of more than 60 countries and regions. The overseas launch of Sugemalimab is about to be fully launched. We will accelerate global layout and commercialization by deeply integrating the advantageous resources of our partners, and fully unleash the clinical value and market potential of Sugemalimab. At the same time, we are also actively promoting cooperation negotiations in Southeast Asia, Canada and other regions , and continue to expand registration applications for other indications of Sugemalimab.
Alessandro Del Bono , CEO of Istituto Gentili, said: "Gentili is committed to providing innovative, high-quality treatment options for cancer patients. We are honored to partner with CStone Pharmaceuticals to bring sugemalimab, an innovative, clinically validated immunotherapy, to patients in Europe and the UK. Sugemalimab has demonstrated strong competitiveness in the immunotherapy field for Stage IV lung cancer, and with the potential for future expansion into Stage III NSCLC, it will provide an important solution to unmet clinical needs in the region."
Sugemalimab also demonstrates strong synergy with our existing pipeline and strategic focus areas. We look forward to working closely with CStone Pharmaceuticals to accelerate access to innovative therapies by building an efficient commercialization pathway, jointly driving medical advancements and providing better solutions to the growing health needs of patients in the region. This agreement is a significant milestone in our company’s development strategy, marking another key step in expanding our oncology pipeline and deepening our presence in the European market.
About Zegemet ( sugemalimab injection)
Sugemalimab was developed by CStone Pharmaceuticals using the OmniRat transgenic animal platform, a one-stop platform for generating fully human antibodies. As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab closely resembles the natural G-type immunoglobulin 4 (IgG4) of the human body, minimizing the potential risk of immunogenicity and related toxicities in patients.
The European Commission (EC) and the UK 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 who lack EGFR-sensitizing mutations or genomic tumor alterations in ALK, ROS1, or RET. A new indication application for sugemalimab was submitted to the EMA in March 2025 for the treatment of patients with unresectable Stage III NSCLC who have not progressed after concurrent or sequential chemoradiotherapy (CRT).
Currently, China’s National Medical Products Administration (NMPA) has approved five indications for sugemalimab:
First-line treatment in combination with chemotherapy for metastatic non-squamous NSCLC and metastatic squamous NSCLC without EGFR or ALK gene mutations;
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).