NMPA approves IND application for HLX97 for the treatment of advanced or metastatic solid tumors
Shanghai Henlius Biotech, Inc. (2696.HK) today announced that the NMPA has approved the IND application for HLX97, a novel oral small molecule inhibitor targeting Lysine Acetyltransferase 6A/B (KAT6A/B) independently developed by the company, for the treatment of advanced or metastatic solid tumors. It is expected to provide a new therapeutic option for patients with breast cancer and other solid tumors who have progressed on standard therapies.
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.