Novartis(US:NVS) Ge Long Hui·2025-08-18 11:49Core 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].