智通财经APP讯，苑东生物(688513.SH)发布公告，公司控股子公司上海超阳药业有限公司(以下简称“上海超阳药业”)自主研发的化学药品1类创新药HP002片正在开展用于治疗复发或难治的B细胞非霍奇金淋巴瘤(B-NHL)I/II期临床试验，于近日完成首例受试者入组给药。
HP-002片是新一代具备透脑能力、靶向BTK(布鲁顿酪氨酸激酶)的蛋白降解靶向嵌合体(PROTAC)分子，在临床前研究中对多种BTK突变细胞株表现出强大的抗增殖活性。
该研究I期主要研究目的为在剂量递增阶段评价HP-002在复发或难治的B细胞非霍奇金淋巴瘤(B-NHL)患者中的安全性和耐受性，探索最大耐受剂量并确定II期试验推荐给药剂量;同时评估HP-002在B-NHL患者中的药代动力学(PK)、药效动力学(PD)特征及初步抗肿瘤作用和疗效相关生物标志物。II期主要研究目的为在剂量扩展阶段评估HP-002在B-NHL患者中的初步疗效，并评估其安全性、耐受性、PK及PD特征，以及疗效相关生物标志物和脑脊液PK特征。截至本公告披露日，该研究I期剂量递增阶段已完成首例受试者入组给药。
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