智通财经APP讯，派林生物(000403.SZ)发布公告，近日，广东双林收到国家药品监督管理局核准签发的《药物临床试验批准通知书》(通知书编号：2025LP00983)，同意广东双林开展静注人免疫球蛋白(10%)新增适应症为治疗慢性炎性脱髓鞘性多发性神经根神经病(CIDP)的临床试验。
公司静注人免疫球蛋白(10%)原发免疫性血小板减少症(ITP)适应症正在开展临床试验阶段，新增适应症治疗慢性炎性脱髓鞘性多发性神经根神经病(CIDP)有助于提升公司产品市场竞争力。此外，公司静注人免疫球蛋白(pH4)已于2024年11月向国家药品监督管理局提交工艺变更申请并已受理，目前处于技术审评阶段，静注人免疫球蛋白(pH4)工艺变更后将进一步提升公司第四代静注人免疫球蛋白产品市场竞争力。
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