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
“Antengene announced it has entered into a global clinical collaboration with MSD to evaluate the combination of ATG-022, a CLDN18.2-targeting antibody-drug conjugate (ADC), and MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors. At the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI 2025), Antengene
“Advanced esophageal squamous cell carcinoma is a difficult-to-treat disease, and unfortunately overall survival remains low,” said Marjorie Green, MD, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “The initiation of the pivotal Phase 3 IDeate-Esophageal01 clinical trial demonstrates our shared commitment with Daiichi Sankyo to
“Overall response rate (ORR) was 97% (114/117) with a complete response/stringent complete response (CR/sCR) rate of 68% (79/117) and a very good partial response or higher (>VGPR) rate of 85% (100/117), per International Myeloma Working Group (IMWG) criteria as investigator-assessed. Of those evaluable for minimal residual disease (MRD) testing at
“EMA approval of the MIRACLE trial protocol is a huge milestone for us. Although we’re already seeing recruitment in our first non-EU country, we believe that this expansion into the EU really supercharges our recruitment potential,” said Walter Klemp, Chairman and CEO of Moleculin. “Importantly, when combined with the sites