迪哲医药(688192) - 2023年11月投资者关系活动记录表

Group 1: Product Approval and Sales Performance - Shuwozhe® (generic name: Shuwotini) received approval from the National Medical Products Administration on August 22, 2023, for treating advanced non-small cell lung cancer (NSCLC) with EGFR Exon 20 insertion mutations [3] - As of the end of Q3 2023, Shuwozhe® achieved sales revenue of CNY 40.124 million [3] Group 2: Market Potential and Clinical Efficacy - Shuwozhe® is the first targeted drug developed in China for advanced NSCLC with EGFR Exon 20 insertion mutations, potentially becoming the only Class I new drug approved for this indication in China [4] - EGFR Exon 20 insertion mutations account for approximately 12% of all EGFR mutations, representing a significant clinical need due to the lack of effective targeted therapies [4] - The objective response rate (ORR) for Shuwozhe® in second-line treatment of advanced NSCLC with EGFR Exon 20 mutations reached 61%, indicating a promising treatment option [5] - In the latest clinical study presented at the 2023 ESMO conference, the ORR for Shuwozhe® in first-line treatment was confirmed at 78.6%, with a median progression-free survival (mPFS) of 12.4 months in the 300 mg group [5] Group 3: International Clinical Trials and Development Plans - Shuwozhe® is undergoing international registration clinical trials in North America, Europe, and South America for both first-line and second-line treatments of advanced NSCLC with EGFR Exon 20 mutations [6] - The company is accelerating the global registration clinical trials for Shuwozhe® in first-line and subsequent-line treatments of advanced NSCLC with EGFR Exon 20 mutations [6] Group 4: Other Drug Developments - The application for Golixitinib, a treatment for relapsed or refractory peripheral T-cell lymphoma (r/r PTCL), was accepted by the National Medical Products Administration in September 2023 and is currently under review [7] - Golixitinib demonstrated an ORR of 44.3% in clinical trials for r/r PTCL, nearly double that of existing treatment options, with over half of the patients achieving complete response [8] - DZD8586, a novel dual-target small molecule inhibitor, is being developed for B-cell non-Hodgkin lymphoma (B-NHL) and is currently in Phase I clinical trials [9]