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Core Viewpoint - Qilu Pharmaceutical has submitted a listing application for the generic drug Budesonide enteric-coated capsules, which has been accepted by the CDE, marking a significant step in the competitive landscape for this medication in China [1][12]. Company Summary - Qilu Pharmaceutical is actively pursuing the development of Budesonide enteric-coated capsules, which is the first generic version of this drug in the domestic market [1][7]. - The company has over 35 products currently under review, with more than 20 of these submitted this year, indicating a robust pipeline and commitment to expanding its product offerings [10][12]. - If approved, Budesonide enteric-coated capsules will be the first generic version in China, potentially positioning Qilu as a leader in this therapeutic area [12]. Industry Summary - Budesonide is a glucocorticoid with anti-inflammatory properties, and its inhalation formulations have seen significant sales, with over 5.3 billion yuan in sales expected in 2024, reflecting a year-on-year growth of 31.94% [4][6]. - The market for Budesonide enteric-coated capsules is anticipated to grow, especially with the recent approval of this formulation for IgA nephropathy, making it the only drug approved for this indication in China [4][12]. - Currently, only the original drug is available in the market, creating a competitive environment as multiple companies, including Qilu, Hainan Huirui Pharmaceutical, and Shijiazhuang Yiling Pharmaceutical, have submitted applications for the same generic product [7][10].