中国生物制药1类创新药派安普利单抗两大适应症获FDA批准

Core Viewpoint - China National Pharmaceutical Group's PD-1 monoclonal antibody, Anike (Paimupili injection), has received FDA approval for treating recurrent or metastatic nasopharyngeal carcinoma (NPC) as a first-line therapy and for patients who have failed platinum-based chemotherapy [1][2] Company Summary - Anike is the first innovative drug product from China National Pharmaceutical Group to be approved in the U.S. market [1] - The drug has already been approved for four indications in China, including first-line and subsequent treatment for advanced NPC, and two additional indications for lung cancer and Hodgkin lymphoma [1] - The FDA previously granted breakthrough therapy designation, orphan drug status, and fast track designation for Anike in treating NPC [2] - The CEO of China National Pharmaceutical Group emphasized that the U.S. approval reflects the alignment of China's innovative drug development with international standards and aims to provide new immunotherapy options for NPC patients globally [2] Industry Summary - In 2018, there were approximately 129,000 new cases of NPC globally, accounting for 0.7% of all cancer diagnoses [3] - Over 70% of NPC patients are diagnosed at an advanced stage, and those with recurrent/metastatic NPC have a poor prognosis, with a median overall survival of less than 20 months [3] - There is a significant unmet clinical need for effective treatments for advanced NPC patients [3]