百利天恒iza-bren被纳入优先审评程序

Core Insights - The company, Baile Tianheng, announced that its self-developed drug, iza-bren, has been included in the priority review list by the National Medical Products Administration (NMPA) [1] - Iza-bren is the world's first and only EGFR×HER3 dual-targeted antibody-drug conjugate (ADC) to enter Phase III clinical trials [1] - The intended indication for iza-bren is for patients with recurrent or metastatic nasopharyngeal carcinoma who have failed at least two lines of chemotherapy, including at least one platinum-based regimen, after prior treatment with PD-1/PD-L1 monoclonal antibodies [1] Company Summary - Baile Tianheng is recognized for its innovative approach in developing the first-in-class dual-targeted ADC, which highlights its commitment to advancing cancer treatment [1] - The inclusion of iza-bren in the priority review list signifies a potential acceleration in the drug's approval process, which could lead to significant market opportunities [1] Industry Context - The development of dual-targeted therapies like iza-bren reflects a growing trend in the oncology field towards more personalized and effective treatment options for complex cancers [1] - The prioritization by regulatory authorities indicates a positive outlook for novel therapies in addressing unmet medical needs in oncology [1]