Dizal Pharmaceutical(SH:688192)2023-12-12 10:01Group 1: Drug Development and Efficacy - DZD8586 is a novel non-covalent dual-target inhibitor that can fully penetrate the blood-brain barrier, showing promising anti-tumor activity against various B-NHL subtypes, including DLBCL and CNSL [3][4] - The clinical data presented at the 2023 ASH meeting indicates that DZD8586 effectively blocks both BTK-dependent and non-BTK-dependent BCR signaling pathways, addressing resistance mechanisms [3][4] - The objective response rate (ORR) for DZD8586 in patients with multiple lines of treatment failure is encouraging, demonstrating anti-tumor efficacy in BTK inhibitor-resistant patients [4] Group 2: Market and Sales Performance - The company reported a sales revenue of RMB 40.1 million for Shuwozhe® in September 2023, with expectations for continued sales growth [5][6] - Shuwozhe® has achieved an ORR of 61% in clinical trials, with a confirmed ORR of 78.6% for the 300 mg group, indicating its status as a leading treatment for EGFR Exon20 insertion mutation NSCLC [5] - The company is actively pursuing global clinical trials and expanding indications for its core products to enhance product value and achieve profitability [6] Group 3: Research and Development - As of mid-2023, the company has 238 research personnel, with 75% holding graduate degrees or higher [5] - The company is in the process of normal review for refinancing and exploring other financing channels, including bank credit, to support ongoing research and development [6] Group 4: Regulatory and Clinical Trials - The company’s core products, including Shuwozhe® and Golixitini, are in the registration clinical trial phase, with updates to be announced as progress is made [4][6] - The NDA for a new drug targeting relapsed/refractory peripheral T-cell lymphoma was accepted by NMPA in September 2023 and is under priority review [6]