On August 27, 2024 HanX Biopharmaceuticals reported that it has received approval from the National Medical Products Administration ( NMPA) for its HX301 clinical trial (Press release, HanX Biopharmaceuticals, AUG 27, 2024, View Source [SID1234655960]). This application meets the relevant drug registration requirements and authorizes Hans Ait Pharmaceuticals to conduct a clinical trial combining this product with temozolomide for glioblastoma.
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HX301 (Narazaciclib ) is a clinical-stage investigational small molecule multikinase inhibitor being jointly developed by Hans -Eti and international partners. Two Phase I clinical trials have been conducted and completed in the United States and China. Phase I monotherapy data demonstrated favorable safety and tolerability, supporting entry into Phase II and combination trials. The company currently plans to conduct multicenter Phase II trials in China and the United States for multiple clinical indications. Preclinical animal model studies have demonstrated that HX301 can cross the blood-brain barrier and exhibits monotherapy activity against glioblastoma, with enhanced activity when combined with temozolomide.
Dr. Lei Zhang, Chief Medical Officer of HansAiTec, said: "We are very pleased that HX301 has received clinical approval from the National Medical Products Administration. Despite various attempts in recent years, there have been no major breakthroughs in the field of glioblastoma, and many challenges still exist. Therefore, the development of new drugs has great potential. We look forward to rapidly advancing this clinical trial to provide patients with new treatment options to meet unmet medical needs."