Supplemental NDA for Toripalimab as Perioperative Treatment for Resectable NSCLC Patients approved
“This approval of the new perioperative lung cancer indication signifies the expansion of toripalimab’s treatment population from late-stage to early-stage cancer patients. One of the first domestic pharmaceutical companies to initiate clinical trials for perioperative immunotherapy, Junshi Biosciences entered the perioperative immunotherapy arena very early on and now holds the broadest spectrum of indications in China. Presently, cancer immunotherapy has evolved into the standard treatment for various late-stage cancers, we are confident that this innovative therapy will lead to breakthrough changes in early cancer treatment and become the preferred treatment option for patients seeking long-term benefits,” said Dr. Jianjun ZOU, Global Research and Development President of Junshi Biosciences.
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.