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李氏大药厂(00950.HK):NATULAN取得药品注册许可证
格隆汇 05-19 21:44

格隆汇5月19日丨李氏大药厂(00950.HK)公吿,于2022年4月19日,Natulan(盐酸丙卡巴肼胶囊)已取得中国国家药品监督管理局的药品注册许可证。Natulan获认可用于结合化疗医治成人霍奇金淋巴瘤。

有关认可建基于在中国进行的开放标签、随机、对照、多中心临床研究的结果,当中会比较基线BEACOPP(包括博来霉素、依托泊苷、盐酸阿霉素(阿霉素)、环磷醯胺、长春新硷(安可平)、甲基苄肼及泼尼松的联合化疗)及ABVD(包括盐酸阿霉素(阿霉素)、博来霉素、长春硷及达卡巴嗪的联合化疗)治疗方案对晚期霍奇金淋巴瘤患者的安全客观缓解率。合共93名晚期霍奇金淋巴瘤患者已入组,而研究不仅与其主要最终目标匹配(即基线BEACOPP组别的客观缓解率不逊于ABVD组别),且于完成四个周期治疗后,基线BEACOPP组别(每个周期21日)患者的完全缓解率亦显着提高至16.22%(6/37),而ABVD组别(每个周期28日)则为2.17%(1/46)。

集团于2018年5月与Leadiant Biosciences签订一项分销协议,获得Natulan于大中华区的独家商品化权利。

据悉,Natulan(盐酸丙卡巴肼胶囊)结合化疗适用于医治霍奇金淋巴瘤及若干脑癌(如多形性胶质母细胞瘤),为一组称为烷化剂的药物的其中一项。Hoffmann-La Roche为Natulan原开发公司,最先送交专利存档并声称拥有Natulan的筹备过程及用途。

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