Core Viewpoint - The approval of the innovative drug Shuwozhe by Dize Pharmaceutical for treating EGFR exon20ins NSCLC marks a significant advancement in addressing a challenging target that has been difficult to treat with existing therapies [1][2]. Group 1: Drug Approval and Market Position - Dize Pharmaceutical's drug Shuwozhe has received accelerated approval from the FDA for use in adult patients with locally advanced or metastatic NSCLC harboring EGFR exon20ins mutations [1][2]. - Shuwozhe is recognized as the first and only small molecule targeted therapy for EGFR exon20ins NSCLC globally, having previously received approval in China [2]. Group 2: Clinical Research and Development - The approval was based on data from the international multicenter clinical study "Wukong 1B," which demonstrated the efficacy and safety of Shuwozhe in patients with EGFR exon20ins NSCLC [3]. - The drug's submission process involved extensive communication with the FDA, ensuring alignment on data and documentation requirements, and achieving a "zero deficiency" status during the independent registration process [3]. Group 3: Strategic Vision and Internationalization - Dize Pharmaceutical aims for global market competitiveness through solid scientific research and early international multicenter clinical trials [4]. - The company emphasizes the importance of maintaining a clear strategic focus and adaptability in the face of unforeseen events during international clinical trials [4]. - Dize Pharmaceutical's strategy includes direct market entry for its drugs, contrasting with other domestic companies that often rely on external partners for commercialization [4][5].