NMPA approves IND for a Ph 1b/2 Clinical Trial of PD-L1-Targeting ADC HLX43
“Shanghai Henlius Biotech, Inc. announced that the investigational new drug (IND) application for a phase 1b/2 clinical trial of HLX43 for Injection, the antibody-drug conjugate (ADC) product that developed by the company based on the collaboration with MediLink Therapeutics, has been approved by the China National Medical Products Administration (NMPA), for monotherapy or combination therapy to treat patients with advanced/metastatic solid tumours. In November 2023, a phase 1 clinical trial of HLX43 has completed dosing its first subject, making it the first PD-L1-targeting ADC in China to enter a clinical trial. At present, no PD-L1 targeting ADC has been approved for marketing globally.”
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.