Imlifidase大大改善了敏感移植病人的肾功能和透析独立性,林业发展局预计到2025年底予以核准。 Imlifidase significantly improved kidney function and dialysis independence in sensitized transplant patients, with FDA approval expected by late 2025.

Imlifidase在美国实现了它的首要目标 Imlifidase met its primary goal in a U.S. 第3阶段对肾移植病人进行试验,与控制相比,12个月肾功能明显改善,平均eGFR为51.5对19.3毫升/min/1.73m2。 Phase 3 trial for kidney transplant patients, showing significantly better kidney function at 12 months compared to controls, with a mean eGFR of 51.5 vs. 19.3 mL/min/1.73m². 治疗还改善了透析独立性,并且在高度敏感且很少有移植选择的接受者中得到了良好的教育。 The treatment also improved dialysis independence and was well-tolerated in highly sensitized recipients with few transplant options. Hansa Biopharma计划到2025年底争取林业发展局批准,并称其成果是几十年来进展有限的一个领域的一个潜在突破。 Hansa Biopharma plans to seek FDA approval by late 2025, citing the results as a potential breakthrough in a field with limited advances in decades. 预计2026年取得全面结果。 Full results are expected in 2026.