CStone Pharmaceuticals Enters Exclusive Commercialization Partnership with Istituto Gentili for Sugemalimab in Western Europe and the UK​

July 8, 2025 – CStone Pharmaceuticals (Stock Code: 2616.HK), an innovative biopharmaceutical company focused on anti-tumor drug research and development, announced that it has reached an exclusive strategic cooperation with Istituto Gentili ("Gentili"), a century-old oncology biopharmaceutical company with deep roots in the European market, regarding the commercialization of sugemalimab in Western Europe and the UK.​

According to the terms of the agreement, Gentili will obtain exclusive commercialization rights for sugemalimab in 23 countries, including 18 European Economic Area (EEA) countries: Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Malta, the Netherlands, Norway, Portugal, Spain, Sweden, as well as the United Kingdom, Andorra, Monaco, San Marino, and the Vatican. CStone Pharmaceuticals will receive upfront payments, regulatory and sales milestone payments from Gentili, with the total transaction amount potentially reaching up to $192.5 million. Additionally, by supplying sugemalimab to Gentili, CStone Pharmaceuticals will also receive approximately 50% of the net sales revenue share of sugemalimab in the authorized regions. Going forward, Gentili will be fully responsible for the registration and commercialization-related activities of sugemalimab in the aforementioned regions.​

Dr. Yang Jianxin, Chief Executive Officer, Head of Research and Development, and Executive Director of CStone Pharmaceuticals, stated: "Sugemalimab is the first PD-L1 monoclonal antibody approved in the EU and the UK for first-line treatment of all populations with stage IV non-small cell lung cancer in combination with chemotherapy, regardless of histological subtype and PD-L1 expression level. Currently, the new indication application for stage III NSCLC has been accepted by the European Medicines Agency (EMA). If approved successfully, sugemalimab will become the second PD-(L) 1 antibody for this indication in Europe. With its profound oncology expertise, mature commercialization system, and patient-centered innovative philosophy, Gentili is an ideal partner to accelerate the accessibility of sugemalimab in the European market. Nowadays, expanding the accessibility of therapies with significant clinical value like sugemalimab has become an urgent task for the global medical community. Up to now, we have reached four major commercialization partnerships for sugemalimab in Europe, the Middle East and Africa, and Latin America, covering more than 60 countries and regions in total. The overseas launch of sugemalimab is about to be fully initiated. We will accelerate global and commercialization by deeply integrating the advantageous resources of our partners, and fully release 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 continuously expanding the registration and declaration of other indications of sugemalimab."​

The clinical value of sugemalimab has been fully verified in multiple studies. The long-term survival data of its phase III clinical study (GEMSTONE-302) on first-line treatment of squamous and non-squamous stage IV non-small cell lung cancer (NSCLC) (non-oncogene-driven type) in combination with platinum-containing chemotherapy was published in the international top comprehensive medical journal The Lancet Oncology. The study showed that in the overall population, the median OS in the sugemalimab group was extended to 25.2 months, and the 4-year survival rate was increased to 32.1%. For patients with baseline brain metastases, the median OS in the sugemalimab group was extended to 26 months, with a 4-year survival rate of 36.4%, and the safety was good. Based on this, sugemalimab has been approved in China, the EU and the UK for first-line treatment of stage IV NSCLC, and has been included in the ESMO guidelines for the treatment of both squamous and non-squamous metastatic NSCLC (non-oncogene-driven type).​

Founded in 1917 and headquartered in Milan, Italy, Istituto Gentili is a biopharmaceutical company focusing on the oncology field, with profound heritage and a mature commercialization system in the European market. It is committed to providing innovative oncology and hemato-oncology treatment solutions, and has rich experience and an extensive market network in the field of cancer treatment.​

This cooperation between CStone Pharmaceuticals and Istituto Gentili is an important step in CStone Pharmaceuticals' global commercialization strategy. By leveraging Gentili's advantages in the European market, sugemalimab is expected to benefit more cancer patients in Western Europe and the UK faster, providing them with new treatment options. At the same time, this cooperation will further enhance CStone Pharmaceuticals' influence in the international market and promote the company's continuous development in the global cancer treatment field. As sugemalimab gradually advances in the European market, its clinical value and market potential are expected to be further released, bringing more benefits to global cancer patients.​