{"id":61878,"date":"2026-03-30T20:38:17","date_gmt":"2026-03-30T12:38:17","guid":{"rendered":"https:\/\/flcube.com\/?p=61878"},"modified":"2026-03-30T20:38:19","modified_gmt":"2026-03-30T12:38:19","slug":"astrazenecas-tezspire-gains-dual-nmpa-approvals-in-china-for-severe-asthma-and-nasal-polyps-based-on-pivotal-phase-iii-data","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=61878","title":{"rendered":"AstraZeneca\u2019s Tezspire Gains Dual NMPA Approvals in China for Severe Asthma and Nasal Polyps Based on Pivotal Phase III Data"},"content":{"rendered":"\n

AstraZeneca plc<\/strong> (NYSE: AZN<\/a>) announced that China\u2019s National Medical Products Administration (NMPA)<\/strong> has approved Tezspire\u00ae (tezepelumab)<\/strong>\u2014a first-in-class thymic stromal lymphopoietin (TSLP)-targeted monoclonal antibody<\/strong> co-developed with Amgen<\/strong> (NASDAQ: AMGN<\/a>)\u2014for two new indications<\/strong>:<\/p>\n\n\n\n

    \n
  1. Add-on maintenance treatment of severe asthma<\/strong> in adults and adolescents aged 12+ years<\/strong><\/li>\n\n\n\n
  2. Combination therapy with intranasal glucocorticoids<\/strong> for chronic rhinosinusitis with nasal polyps (CRSwNP)<\/strong> in adults inadequately controlled by systemic steroids or surgery<\/li>\n<\/ol>\n\n\n\n

    Approvals were based on robust results from the Phase III DIRECTION (asthma)<\/strong> and WAYPOINT (CRSwNP)<\/strong> trials, positioning Tezspire as the first biologic in China to target TSLP upstream in the inflammatory cascade<\/strong>.<\/p>\n\n\n\n

    Pivotal Trial Results<\/h2>\n\n\n\n

    DIRECTION Study \u2013 Severe Asthma<\/strong><\/h3>\n\n\n\n
    Endpoint<\/th>Tezepelumab vs. Placebo<\/th><\/tr><\/thead>
    Annualized Asthma Exacerbation Rate (AAER)<\/strong><\/td>74% reduction<\/strong> (p<0.001<\/em>)<\/td><\/tr>
    Patient Population<\/strong><\/td>Broad severe asthma cohort (eosinophil-low and -high)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

    WAYPOINT Study \u2013 CRSwNP<\/strong><\/h3>\n\n\n\n
    Endpoint<\/th>Tezepelumab vs. Placebo<\/th><\/tr><\/thead>
    Nasal Polyp Severity<\/strong><\/td>Statistically significant & clinically meaningful improvement (p<0.0001<\/em>)<\/td><\/tr>
    Surgery Avoidance<\/strong><\/td>Near elimination<\/strong> of need for sinus surgery (p<0.0001<\/em>)<\/td><\/tr>
    Systemic Glucocorticoid Use<\/strong><\/td>Significant reduction<\/strong> (p<0.0001<\/em>)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

    These data confirm Tezspire\u2019s ability to modulate type 2 inflammation at its source<\/strong>, offering benefits across multiple TSLP-driven conditions.<\/p>\n\n\n\n

    Mechanism & Differentiation<\/h2>\n\n\n\n