Reported Late Monday, Everest Medicines And Kezar Life Sciences Received IND Approval From China's NMPA For The PALIZADE Trial In Lupus Nephritis
Reported Late Monday, Everest Medicines And Kezar Life Sciences Received IND Approval From China's NMPA For The PALIZADE Trial In Lupus Nephritis
Everest Medicines (HKEX 1952.HK) and Kezar Life Sciences, Inc. (NASDAQ:KZR) announced today that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) approved Kezar's investigational new drug (IND) application for initiation of the Phase 2b PALIZADE trial in China of zetomipzomib in patients with lupus nephritis (LN). Zetomipzomib is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases.
珠峰药业（HKEX 1952.HK）和凯泽生命科学有限公司（纳斯达克股票代码：KZR）今天宣布，中国国家药品监督管理局（NMPA）药物评估中心（CDE）批准了凯泽在中国启动针对狼疮肾炎（LN）患者的泽托米佐米2b期PALIZADE试验的研究性新药（IND）申请。Zetomipzomib 是一种新型、同类首创的选择性免疫蛋白酶体抑制剂，在多种自身免疫性疾病中具有广泛的治疗潜力。
Everest will join Kezar and enroll patients in China as part of the ongoing PALIZADE trial, a global, placebo-controlled Phase 2b clinical trial evaluating the efficacy and safety of two dose levels of zetomipzomib or placebo in patients with active LN. In September 2023, Everest obtained exclusive rights to develop and commercialize zetomipzomib in Greater China, South Korea and Southeast Asia. LN is the most common secondary immune-mediated glomerular disease, which may gradually lead to kidney failure. There are an estimated 400,000-600,000 LN patients in China.
作为正在进行的PALIZADE试验的一部分，Everest将加入Kezare并在中国招收患者。PALIZADE试验是一项全球性的安慰剂对照的2b期临床试验，旨在评估两种剂量水平的泽托米佐米或安慰剂对活性LN患者的疗效和安全性。2023年9月，珠穆朗玛峰获得了在大中华区、韩国和东南亚开发和商业化泽托米佐米的独家权利。LN 是最常见的继发性免疫介导的肾小球疾病，可能逐渐导致肾衰竭。据估计，中国有40万至60万名LN患者。