China-based Hanx Biopharmaceuticals (Wuhan) Co., Ltd. announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its HX044. This follows the initiation of a Phase I study for the CTLA-4 bispecific antibody (BsAb) in Australia. The approval marks a significant step in the global development of this next-generation immune checkpoint inhibitor.
Innovative Immune Checkpoint Inhibitor
HX044 is designed to treat multiple malignant tumors, including PD-1 resistant solid tumors such as non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma, and gastrointestinal cancer. This next-generation CTLA-4 immunotherapy aims to expand the therapeutic window, optimize safety, and enhance antitumor immune responses. HX044 represents a breakthrough in CTLA-4 immunotherapy, offering new hope for patients with difficult-to-treat cancers.
Future Development and Clinical Trials
With the NMPA’s approval, Hanx Biopharmaceuticals is poised to advance the clinical development of HX044. The company will conduct clinical trials to evaluate the safety and efficacy of HX044 in treating various types of cancer. These trials will provide valuable data to support the potential use of HX044 in addressing unmet medical needs in oncology.-Fineline Info & Tech
