CHMP Positive Opinion for Sugemalimab in Stage III NSCLC
Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, remarked, “We are encouraged that the EMA review for our Stage III NSCLC indication has progressed so rapidly and positively. Coming just one year after sugemalimab’s first approval in Europe for first-line metastatic squamous and non-squamous NSCLC in 2024, this marks the second positive opinion and recommendation from CHMP. If approved, sugemalimab’s role as a core immunotherapy for lung cancer will be further solidified, significantly enhancing its market presence and commercial potential. We will work closely with our partners to expedite the full commercialization of sugemalimab across European markets, making this high-quality and accessible treatment option available to more patients.”
Share:
More News
“The designation reinforces the significant unmet need for effective treatment options for patients with advanced breast cancer,” said Charles Baum, M.D., Ph.D., Chief Executive Officer of Terremoto Biosciences. “We are committed to advancing highly selective therapies designed to expand treatment options for patients with difficult to treat cancers.”
“Up to five U.S. clinical sites are planned for THIO-101 Parts C and D this year, and we expect to activate a second U.S. site in the coming weeks,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “To date, data has shown overall survival (OS) beyond two
Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important milestone in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of first-line lung cancer treatment indications in the EU.