80亿美元JAK抑制剂，山东药企冲刺首仿！

Core Viewpoint - The acceptance of the market application for the generic drug Upadacitinib extended-release tablets by Shandong Nuohuo Kang Pharmaceutical Co., Ltd. marks a significant development in the competitive landscape of the JAK inhibitor market, which is projected to reach $8 billion in annual sales by 2026 [1][5][17]. Group 1: Market Dynamics - Upadacitinib, developed by AbbVie, has seen explosive sales growth since its FDA approval in August 2019, with sales increasing from $47 million in its initial year to approximately $2.7 billion in 2023 [3][5]. - The global market demand for Upadacitinib is rapidly increasing, with a projected annual sales figure nearing $8 billion by 2026 [5]. - In China, the sales of Upadacitinib have surged, with a reported increase of over 9271% in 2023, reaching sales of 81.71 million yuan, and further projected growth of 12098% in the first half of 2024 [9]. Group 2: Competitive Landscape - A total of 15 generic pharmaceutical companies have submitted applications for Upadacitinib, indicating a highly competitive environment for the first generic version [11]. - The patent landscape has shifted, with the core compound patent for Upadacitinib declared invalid in China, allowing generic manufacturers to enter the market sooner than expected [14][16]. - The ongoing patent disputes and the approval of new indications for Upadacitinib are expected to intensify competition among generic manufacturers [17].