EMA CHMP Recommends Approval of Cejemly® (sugemalimab) as 1L Treatment for NSCLC
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.”
Share:
More News
“These data underscore gotistobart’s potential to redefine treatment for patients with hard-to-treat squamous NSCLC whose disease has progressed after initial therapy and who face limited options,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “In second- and later lines of treatment, the clinical relevance of novel
“The collaboration with Ratio represents an exciting opportunity to explore the potential of novel radiopharmaceutical approaches designed to address the complexity and heterogeneity of cancer,” said Ben Hickey, President of RayzeBio. “The combination of our respective technologies and complementary development expertise creates a strong foundation for generating a novel differentiated
“We believe these results mark a potentially important step forward in the treatment of EGFR exon 20 insertion mutation-positive non-small cell lung cancer,” said Fabio Benedetti, MD, Global Chief Medical Officer, Taiho Pharmaceutical. “To address the unmet medical needs of patients and their families, we will continue working closely with
“Recent clinical data validated KAT6 as a targetable mechanism in the treatment of HR+/HER2- breast cancer, including those with actionable mutations,” stated Charles Morris, MBChB, MRCP, Chief Medical Officer of Prelude. “Dual KAT6A/B inhibitors, however, demonstrated overlapping toxicities with current backbone therapies that may limit the utility in earlier lines