Dizal Pharmaceutical(688192)2024-05-20 10:31Group 1: Product Approval and Clinical Trials - Shuwozhe® is the only approved small molecule TKI for EGFR Exon20ins mutation NSCLC, with international multi-center registration clinical study (WUKONG1 Part B) completed in November 2023, preliminary results to be presented at ASCO 2024 [3][4] - Shuwozhe® received breakthrough therapy designation from the FDA, making it the only drug in this field with such recognition, and is currently undergoing a global Phase III clinical trial (WUKONG28) [4] Group 2: Market Performance and Sales - Shuwozhe® achieved sales revenue of 51.19 million yuan in Q4 2023 and 81.32 million yuan in Q1 2024, reflecting strong market performance since its approval in August 2023 [4] - The drug is rated as a Class I recommendation in the CSCO guidelines for NSCLC treatment, indicating high recognition of its clinical value by experts [4] Group 3: Regulatory Progress - The NDA for Goliqixitin was accepted by the National Medical Products Administration in September 2023 and is currently under priority review [5]