肝病创新药在京开出内地首张处方

Core Viewpoint - An innovative imported drug for rare diseases has been prescribed for the first time in mainland China, providing new hope for patients with primary biliary cholangitis [1] Group 1: Drug Introduction and Impact - The drug was introduced at Beijing Friendship Hospital, benefiting a patient with primary biliary cholangitis, a chronic liver disease classified as a rare disease [1] - The drug is expected to effectively improve symptoms and prognosis for patients, offering a safer treatment option compared to existing therapies [1] - The rapid introduction of the drug was facilitated by a temporary import policy for urgently needed clinical drugs in the Tianzhu Comprehensive Bonded Zone [1] Group 2: Regulatory and Market Context - The drug has already been approved for sale abroad and is currently only available for prescription at Beijing Friendship Hospital in mainland China [1] - The Tianzhu Comprehensive Bonded Zone is the first airport-type comprehensive bonded zone in the country, which aims to explore the import of rare disease drugs not yet registered in China [1] - In November 2023, the State Council approved the establishment of a rare disease drug guarantee pilot area in Tianzhu, further addressing the clinical medication needs for rare diseases [1]