CStone Announces European Medicine Agency CHMP Recommends Approval of Cejemly® (sugemalimab, anti-PD-L1) as First-Line Treatment for NSCLC

• EMA CHMP recommendation is based on the results of a Phase 3 clinical trial (GEMSTONE-302) demonstrating significant progression-free survival (PFS) and overall survival (OS) benefits of sugemalimab in combination with chemotherapy as a first-line treatment for non-small cell lung cancer (NSCLC).
• Sugemalimab is expected to become the first anti-PD-L1 monoclonal antibody (mAb) in the world approved in Europe for both first-line squamous and non-squamous NSCLC, regardless of PD-L1 expression, potentially also the first domestic anti-PD-L1 mAb marketed in ex-China regions.
• In addition to the recent partnership with Ewopharma in Central Eastern Europe and Switzerland, multiple potential partners in other countries or regions are in deep conversations with CStone for sugemalimab.

SUZHOU, China, June 1, 2024 /PRNewswire/ -- CStone Pharmaceuticals (HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of sugemalimab in combination with chemotherapy as a first-line treatment for metastatic non-small cell lung cancer (NSCLC), which is one of the largest cancer indications and a leading cause of cancer death in the world. Sugemalimab is expected to become the first anti-PD-L1 monoclonal antibody (mAb) approved in Europe for both first-line squamous and non-squamous NSCLC, regardless of PD-L1 expression, also making CStone the very first biopharmaceutical company in China to potentially launch a domestic anti-PD-L1 mAb in ex-China markets.

Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, said, "The positive opinion from EMA CHMP normally indicates an upcoming approval for market authorization by the European Commission, marking a significant milestone not only for sugemalimab but also for CStone and the entire pharmaceutical industry in China. The CHMP recommendation brings us closer to delivering this innovative treatment to European patients with lung cancer, and it also highlights a major milestone in CStone's global strategy. Stage IV NSCLC is the first of several other indications where sugemalimab has been shown to bring significant benefits and we are planning to file for registration in these other important indications including stage III NSCLC, gastric cancer, esophageal cancer, etc. In addition, we have been actively engaging in substantive discussions with numerous other potential partners in various countries or regions to follow our recently announced strategic commercial collaboration with Ewopharma in Central Eastern Europe and Switzerland. We are confident and eagerly anticipate collaborating to swiftly propel sugemalimab into broader global markets and benefiting more patients across multiple indications. I would also like to thank the CStone team for their hard work and persistence over the years to achieve this important milestone."

CHMP recommendation is primarily based on the results of GEMSTONE-302, a multi-center, randomized, double-blind, Phase 3 clinical trial. Sugemalimab in combination with chemotherapy significantly improved PFS and OS compared to placebo in combination with chemotherapy in previously untreated stage IV NSCLC patients. The study results have been published in The Lancet Oncology and Nature Cancer and reported in oral sessions at various international academic conferences.

Sugemalimab is an anti-PD-L1 monoclonal antibody developed by CStone, which has been approved in China for five indications, including stage III and IV NSCLC, extranodal NK/T-cell lymphoma, esophageal squamous cell carcinoma, and gastric cancer. Additionally, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) is currently reviewing the marketing authorization application for sugemalimab combined with chemotherapy as a first-line treatment for metastatic NSCLC. The company is also in communications with regulatory authorities such as the EMA, MHRA, and U.S. Food and Drug Administration (FDA) regarding additional indications for sugemalimab and is actively seeking development and commercialization partnerships in other countries and regions worldwide.