Core Viewpoint - Qilu Pharmaceutical's application for the marketing authorization of phospho-lusatinib tablets has been accepted, marking its entry into the competitive landscape of domestic generics for this drug, which has a projected global sales exceeding $4.7 billion in 2024 [1][4]. Group 1: Market Performance and Sales Data - Phospho-lusatinib, a first-in-class JAK1/JAK2 inhibitor, has shown impressive market performance since its launch, with global sales reaching nearly $4 billion in 2022 and increasing to approximately $4.314 billion in 2023, with a forecasted rise to $4.728 billion in 2024 [4][7]. - In China, the sales of phospho-lusatinib exceeded 200 million yuan in 2020, growing to 553 million yuan in 2023, and expected to increase by 16.11% to 642 million yuan in 2024 [7]. Group 2: Competitive Landscape - Qilu Pharmaceutical is competing with other companies, including Chengdu Yuandong Biological and 19 other firms, in the race to become the second domestic producer of phospho-lusatinib, with multiple applications currently under review [13][19]. - Chengdu Yuandong Biological has already secured the first generic approval for phospho-lusatinib, indicating a competitive environment for Qilu Pharmaceutical's application [11]. Group 3: Patent and Regulatory Information - The patent for phospho-lusatinib is protected until June 12, 2028, with several patents granted in China and other regions, which may impact the competitive landscape for generics [9][10]. - Qilu Pharmaceutical's previous application for the same product was not approved, highlighting the challenges in the regulatory process [17].

Core Insights - Chengdu Yuandong Pharmaceutical Co., Ltd. reported a record high revenue of 1.35 billion RMB in 2024, marking a year-on-year growth of 20.82% [1] - The net profit attributable to shareholders reached 238 million RMB, with a growth of 5.15%, and a net profit growth of 13.47% after excluding stock incentive expenses [1] - The company plans to distribute a cash dividend of 4.3 RMB per 10 shares to all shareholders [1] Revenue Breakdown - The formulation segment generated 1.077 billion RMB, reflecting a year-on-year increase of 22.25% [1] - The raw material segment achieved 121 million RMB in revenue, up 28.65% year-on-year [1] - CMO/CDMO business saw a significant revenue increase of 111.59%, reaching 65.2 million RMB [1] Product Development and Approvals - Yuandong submitted 18 new formulation product registration applications and received approvals for 13 products, including domestic first generics [2] - The company is advancing its international strategy, with key approvals from the FDA and EU for various raw materials [2] - The company successfully shipped its first product to the U.S. market, marking a significant commercial breakthrough [2] Digitalization and R&D Investment - The company is accelerating the integration of digitalization and smart manufacturing in the pharmaceutical industry [3] - R&D investment reached approximately 288 million RMB, a year-on-year increase of 16.88%, with nearly 30% allocated to new drug development [3] - Over 10 first-class new drugs are currently in the research pipeline [3] Strategic Focus and Market Position - The company maintains a strong focus on the anesthetic and analgesic sector, establishing a comprehensive industry chain from raw materials to formulations [4] - The integration of R&D systems with international standards supports the company's new drug development and market expansion [4] - The company's ability to innovate and respond quickly to market changes enhances its competitive edge in a challenging market environment [3][4]