Dizal Pharmaceutical(688192)2024-11-06 07:37Financial Performance - In the first three quarters of 2024, the company achieved a sales revenue of 338 million CNY, representing a year-on-year growth of 744% [2] - The net loss attributable to shareholders for the same period was 558 million CNY, narrowing by 33% year-on-year [2] Product Development and Clinical Trials - The global registration clinical trial "WUKONG1B" for Shuwozhe® (generic name: Shuwotini tablets) has reached its primary research endpoint, with over 40% of non-Asian patients included [2] - The clinical trial results for the "JACKPOT8B" study of Gaoruizhe® have also reached the primary research endpoint, with results presented at the 2023 ASH conference and published in the international journal Lancet Oncology [3] - The company is actively preparing for overseas new drug listing applications based on these clinical trial results [3] Pipeline and Future Prospects - The company is exploring the application of its marketed products in lung cancer, with ongoing global registration clinical trials for Shuwozhe® in first-line treatment of EGFR Exon20ins mutation NSCLC [3] - Two new products, DZD6008 and DZD8586, are under development, targeting unmet clinical needs in lung cancer and hematological malignancies [4] - DZD6008 is a novel small molecule targeted inhibitor for NSCLC, currently in Phase I clinical trials in China [4] - DZD8586 is a dual-target small molecule inhibitor that can penetrate the blood-brain barrier, with ongoing Phase II clinical studies for CLL/SLL and DLBCL [5] Clinical Efficacy - DZD8586 has shown promising anti-tumor activity and safety in patients with multiple B-NHL, with an overall response rate (ORR) of 64.7% in patients who had previously received three lines of treatment [5] - In patients with DLBCL, the ORR reached 83.3%, and in those who had previously received BTK inhibitors, the ORR was 50% [5]