Core Insights - Novartis announced the approval of its innovative drug, Rimegepant (Rimebuntin Tablets), by the National Medical Products Administration for adults with chronic spontaneous urticaria (CSU) inadequately controlled by H1 antihistamines [1] Group 1: Drug Approval and Market Context - Rimegepant is specifically indicated for adult patients suffering from CSU, a condition characterized by hives, itching, or angioedema occurring daily or intermittently for more than six weeks [1] - CSU is the most common type of chronic urticaria, with over 10 million patients in China [1] - More than 50% of CSU patients do not achieve effective symptom control with standard doses of H1 antihistamines [1] Group 2: Clinical Trial Results - The approval of Rimegepant is based on the results of two pivotal Phase III global multicenter clinical trials, REMIX-1 and REMIX-2 [1] - Patients with CSU who continued to experience symptoms after treatment with second-generation antihistamines showed significant clinical improvement within one week of starting Rimegepant, with effects lasting up to 52 weeks [1] Group 3: Regulatory Process - The application for Rimegepant's market authorization was formally accepted by the National Medical Products Administration in February of this year and was prioritized for review, leading to its approval within nine months [1]