Core Viewpoint - Jiangsu Enhua Pharmaceutical Co., Ltd. has had its application for the market launch of Oxycodone Naloxone Extended-Release Tablets accepted, indicating a significant step in the competitive landscape of pain management medications in China [1][3]. Group 1: Product Overview - Oxycodone Naloxone Extended-Release Tablets are a combination of the potent opioid agonist oxycodone and the opioid antagonist naloxone, designed for treating moderate to severe chronic pain that is not effectively managed by non-opioid medications [3][5]. - The total sales of oxycodone in Chinese hospitals reached CNY 165.52 billion, with a projected sales increase of 13.92% to CNY 17.54 billion in 2024, highlighting its dominant position in the moderate to severe pain treatment market [3][5]. Group 2: Market Dynamics - The market for Oxycodone Naloxone Extended-Release Tablets is expected to be substantial, with potential to disrupt the current market structure dominated by NAPP Pharmaceuticals, which holds a 99.44% market share of oxycodone extended-release tablets in China [5][7]. - The first application for this product was submitted by Green Leaf Pharmaceutical in January 2022 but was not approved, indicating the competitive challenges in the market [7][11]. Group 3: Regulatory and Competitive Landscape - The product has been classified as a Category 4 generic drug, with the application officially accepted on August 19, 2025, marking it as the first approved domestic version of Oxycodone Naloxone Extended-Release Tablets [1][9]. - The high technical barriers and complex patent challenges associated with the product have limited the number of domestic generic manufacturers, with the core patent set to expire in August 2027 [12][17]. Group 4: Industry Trends - The increasing focus on high-barrier products and the shift from simple generics to innovative approaches in the extended-release formulation space reflect a deep adjustment in the industry landscape, driven by heightened competition and the need for technological advancements [17].