舒泰神(300204)：1002顶线结果积极 波米泰酶αBLA获得受理

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The report highlights positive topline results from the clinical trial of STSA-1002 for ARDS, indicating a significant reduction in clinical relief time and mortality rates compared to the control group [6] - The application for the market approval of Bomitase α has been accepted, and the company has completed changes to its drug production license [6] - Revenue projections for 2025-2027 are estimated at 294 million, 448 million, and 1.096 billion respectively, with a forecasted net profit of -76 million, -56 million, and 289 million [6] Financial Performance Summary - Revenue for 2023 is reported at 364 million, with a projected decline to 294 million in 2025 before increasing to 1.096 billion by 2027 [5][8] - The net profit is expected to improve from -399 million in 2023 to a positive 289 million in 2027 [5][8] - The earnings per share (EPS) is projected to rise from -0.84 in 2023 to 0.61 in 2027 [5][8] Clinical Trial Results - The clinical trial for STSA-1002 showed that the low-dose and high-dose groups had risk ratios of 1.04 and 1.55 respectively, with a reduction in the time to clinical relief by 2 to 5 days [6] - The 28-day all-cause mortality rates were 26.67% for the low-dose group, 5.88% for the high-dose group, and 40% for the control group, indicating a significant reduction in mortality [6] Market and Regulatory Developments - The company has received acceptance for the market application of STSP-0601 (Bomitase α), which is a significant regulatory milestone [6] - The report emphasizes the importance of the drug production license changes, which allow for the contracted production of Bomitase α [6]