Core Viewpoint - The company, DQ Medical-B (06996), announced that its internally developed Claudin 18.2 antibody-drug conjugate (ADC) ATG-022 has received breakthrough therapy designation from the China National Medical Products Administration (NMPA) for the treatment of CLDN18.2 positive, HER2 negative unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ) patients who have previously received at least two treatments [1]. Group 1 - The breakthrough therapy designation is a significant regulatory milestone for the company, indicating the potential of ATG-022 in addressing unmet medical needs in a challenging patient population [1]. - The targeted patient group includes those with CLDN18.2 positive and HER2 negative conditions, highlighting the specificity of the treatment [1]. - The designation may facilitate expedited development and review processes for ATG-022, potentially leading to faster market access [1].
德琪医药-B(06996)：ATG-022就治疗胃癌/胃食管结合部腺癌获授予突破性治疗药物认定