医药行业P-CAB：开启抑酸新时代，打造消化创新生态

Industry Overview - P-CAB drugs are a new generation of acid-suppressing drugs with advantages such as convenience, overcoming nocturnal acid breakthrough, and addressing patient genetic heterogeneity, validated by their sales performance in Japan and South Korea [2] - P-CAB drugs have attracted attention from major domestic pharmaceutical companies like Livzon, Fosun Pharma, and Shanghai Pharma, as well as international players like Otsuka and Sebela, leading to multiple licensing deals [2] - P-CAB drugs are gradually replacing PPI in the domestic market, with recent trends showing a shift in market share [2] Market Dynamics - The prevalence of GERD in China is 7.8% in rural areas and 7.7% in urban areas, with a lifetime prevalence of duodenal ulcers at around 10% and H. pylori infection rates between 40-60%, indicating a large patient population [3][4] - Traditional PPIs have limitations such as slow onset, instability in acidic environments, short half-life, and dependency on CYP2C19 metabolism, which P-CAB drugs address with faster onset, acid stability, longer half-life, and CYP3A4 metabolism [5][8] - P-CAB drugs have been included in national guidelines and consensus documents, accelerating their adoption in acid suppression therapy [10][11] Competitive Landscape - In Japan, Vonoprazan's sales have grown steadily, reaching over $600 million in 2023 with a CAGR of 36% from 2015 to 2023, driven by its inclusion in the 2016 H. pylori management guidelines [14][15] - In South Korea, Tegoprazan's quarterly sales have shown steady growth, reaching KRW 81.9 billion in the first half of 2024, a 24.1% YoY increase [16][17] - Domestic P-CAB drugs like Vonoprazan, Tegoprazan, and Keverprazan have gained first-mover advantages, with other P-CAB drugs still in early development stages [22][23] Clinical and Market Performance - Vonoprazan has completed multiple Phase III clinical studies in the US for H. pylori infection and GERD, adding authoritative backing to its clinical value [30][31] - Tegoprazan has been widely licensed in 8 countries, with its domestic market launch being the first P-CAB product developed and promoted by a local Chinese company [33][34] - Tegoprazan has shown superior efficacy in head-to-head studies against PPIs, particularly in H. pylori eradication, with a 93.5% eradication rate compared to 86.4% for Esomeprazole [45][46] Product Differentiation - Tegoprazan demonstrates faster onset and longer-lasting efficacy compared to other P-CABs and PPIs, with a gastric pH ≥4 maintenance time of 68% during nighttime, outperforming Vonoprazan's 60.5% [42][43] - Keverprazan, the first domestically developed P-CAB, has shown superior pharmacokinetic advantages over PPIs, with a longer half-life and better gastric pH control over 24 hours [48][49]