NMPA approves IND for Ph 2 Trial of HLX22
“Shanghai Henlius Biotech, Inc. announced that the investigational new drug (IND) application for a phase 2 clinical trial of the company’s novel anti-HER2 monoclonal antibody (mAb), HLX22, in combination with trastuzumab and chemotherapy or combined with trastuzumab deruxtecan (T-DXd) has been approved by the China National Medical Products Administration (NMPA), for the treatment of HER2-expressing solid tumours. As a novel HER2-targeting mAb, HLX22 has a synergistic anti-tumor effect in combination with trastuzumab. The dual-HER2 blockade therapy has demonstrated anti-tumor efficacy and good safety in investigational studies for the first-line treatment of advanced gastric cancer. Therefore, Henlius intends to further explore the efficacy and safety of HLX22-based anti-HER2 therapies in various types of solid tumours, expected to bring clinical benefits to a wider group of patients with solid tumours.”
Share:
More News
Valerie Vanhooren, Co-Founder and CEO of Ona Therapeutics, added, “ADCs have transformed cancer treatment; however, the technology has been applied to a limited number of tumor targets. These limitations restrict the number of patients who can benefit from treatments and highlight the critical need to identify new broadly expressed tumor
“Elicera Therapeutics AB (publ), a clinical stage cell and gene therapy company developing next generation cancer treatments based on oncolytic viruses and CAR T-cell therapies, armed with immune-activating properties via the company’s commercially available iTANK platform, today announced that the Data Safety and Monitoring Board (DSMB) has completed its first
“Patients deserve more than the currently available treatment options. TAR-200 is a groundbreaking therapy for early-stage bladder cancer, designed to deliver a sustained local release of medication directly into the bladder—right where it is needed,” said Biljana Naumovic, U.S. President, Oncology, Solid Tumor, Johnson & Johnson Innovative Medicine. “This innovation
Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare, said, “Zurletrectinib has demonstrated outstanding efficacy and safety profile in adult, adolescent, and pediatric patients with tumors harboring NTRK fusion genes, bringing better treatment options for patients with solid tumors. The Company is expanding the scope of its solid tumor
