Workflow
创新药新适应症获欧盟批准 百济神州加快拓展全球市场

Core Viewpoint - The European Commission has approved the innovative drug Baiyue An (Tislelizumab) for use in neoadjuvant therapy combined with platinum-based chemotherapy for adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence, further expanding its application in the European oncology market [1] Group 1: Market Context - Lung cancer is the most common cancer globally, with NSCLC accounting for 80%-90% of all lung cancer types, and approximately 25%-30% of NSCLC patients are eligible for surgical resection [1] - The treatment needs of this patient group represent a significant market opportunity for related drugs [1] Group 2: Product Approval and Market Expansion - Tislelizumab has received a total of 9 approvals for solid tumor indications in the EU, including 5 for lung cancer and others for gastric or gastroesophageal junction adenocarcinoma, unresectable esophageal squamous cell carcinoma, and nasopharyngeal carcinoma [2] - Tislelizumab is the first PD-(L)1 inhibitor from China to enter the global market and is a core product developed by the company following the BTK inhibitor Zebutini [2] - The global market presence of Tislelizumab has expanded to 47 countries and regions, including major markets in Europe, the United States, the United Kingdom, and Japan [2]