圣兆药物：利培酮微球首仿获批，多款高端制剂持续推进-20250313

Investment Rating - The report does not provide a specific investment rating for the company Core Insights - The company has received approval for its first generic injectable risperidone microsphere, marking a significant advancement in its high-end formulation development [2][8] - The company is progressing with multiple high-end formulations, including paclitaxel (albumin-bound) and leuprolide microspheres, which are expected to enhance its market position [3][16] - The company has a strong pipeline of products, with several formulations in various stages of development, indicating a robust growth potential [4][26] Summary by Relevant Sections Product Approvals and Developments - The company announced the approval of injectable risperidone microspheres on February 26, 2025, which is the first approved generic version in China [2][8] - The injectable paclitaxel (albumin-bound) has received acceptance for its market registration application, and the leuprolide microsphere has passed bioequivalence trials [16][24] Market Potential - The domestic market for injectable risperidone microspheres is projected to grow significantly, with the overall market for risperidone exceeding 1 billion RMB in 2022 [13][15] - The injectable leuprolide microsphere market was valued at 5.1 billion RMB in 2023, with expectations for continued growth [24] Competitive Advantages - The company has a competitive edge due to its large-scale production capabilities, which allow for significant cost advantages in the market [26][30] - The company’s focus on high-end formulations and its established R&D platform position it favorably against competitors [31][32]