丽珠集团(000513.SZ):注射用双羟萘酸曲普瑞林微球获批临床试验
格隆汇 4 月 7日丨丽珠集团(000513.SZ)公布,近日,公司及全资附属公司珠海市丽珠微球科技有限公司(“丽珠微球”)收到国家药品监督管理局(“药监局”)核准签发的《药物临床试验批准通知书》,药物名称为注射用双羟萘酸曲普瑞林微球。
注射用双羟萘酸曲普瑞林微球历经6年研发,是公司自主开发的高端长效微球制剂,首次提交临床试验申请获得受理的时间为2021年01月20日(受理号:CXHL2100048)。
本产品是每三月一次肌肉注射的一种促性腺激素释放激素激动剂,适应症为局部晚期或转移性前列腺癌的治疗。相比普通曲普瑞林注射剂,具有起效时间长,减少用药次数特点,可减轻患者痛苦和用药负担,提高用药耐受性和可及性。
截至公告日,注射用双羟萘酸曲普瑞林微球累计直接投入的研发费用约人民币1499.45万元。
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