Group 1 - The first prescription of the innovative drug Seladelpar for the treatment of primary biliary cholangitis was issued in mainland China, marking a significant step in the rare disease treatment field [1] - Approximately 30% to 40% of patients with primary biliary cholangitis do not respond well to current first-line treatments, highlighting the need for more effective innovative therapies [1] - Seladelpar has shown promising results in international clinical studies, effectively improving biochemical indicators in patients and alleviating moderate to severe itching, with good safety profiles [1] Group 2 - The rapid approval of Seladelpar was facilitated by the temporary import policy for urgently needed drugs in Beijing and efficient collaboration with a medical supplies trading company [2] - By September 2025, 48 boxes of Seladelpar were stocked in a bonded area, achieving a "medicine waiting for patients" status, and the drug was delivered to medical institutions within 1.5 hours after customs clearance on January 5, 2026 [2] - The company plans to focus on the medication needs of rare disease patients, leveraging policy advantages in Beijing to enhance international supply chain capabilities and accelerate the introduction of global innovative drugs [2]
罕见病创新药司拉德帕中国内地首方从顺义开出