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迪哲医药:舒沃替尼向FDA递交上市申请,国际化取得重要进展

Investment Rating - The investment rating for the company is "Buy" with a 6-month outlook [2][8]. Core Views - The company has submitted a new drug application for Shuwotini to the FDA, marking significant progress in internationalization [2]. - Shuwotini has received breakthrough therapy designation (BTD) in both China and the U.S. for the treatment of EGFR exon 20 insertion mutation non-small cell lung cancer (NSCLC) [3]. - The sales of Shuwotini have rapidly increased since its launch in August 2023, with projected sales of approximately 0.91 billion yuan in 2023 and 2.04 billion yuan in the first half of 2024 [5][6]. - The company is also negotiating for the inclusion of Shuwotini and Golixitinib in the national medical insurance directory, which is expected to further boost sales [6]. Financial Summary - The company's revenue forecast for 2024-2025 has been adjusted down to 5.00 billion yuan and 10.51 billion yuan, respectively, with an expected revenue of 18.96 billion yuan in 2026 [8]. - The net profit attributable to the parent company is projected to be -7.95 million yuan and -3.23 million yuan for 2024 and 2025, respectively, with an expected net profit of -0.30 million yuan in 2026 [8]. - The company reported a significant increase in operating revenue from 0 million yuan in 2022 to 91.29 million yuan in 2023, with further growth expected [9]. Clinical Progress - The company is advancing multiple innovative drugs in clinical trials, including DZD8586, a dual-target small molecule inhibitor, and DZD6008, a small molecule targeted inhibitor for NSCLC [7].