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Clover制药在中国启动依那西普生物仿制药的I期试验

2018-08-02 MedSci MedSci原创

依那西普生物仿制药SCB-808
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Clover制药是一家致力于开发新型和变革性生物疗法的生物技术公司，近日宣布第一名患者在SCB-808（依那西普生物仿制药）的I期试验中给药，用于治疗类风湿性关节炎和其他自身免疫性疾病。

Clover制药是一家致力于开发新型和变革性生物疗法的生物技术公司，近日宣布第一名患者在SCB-808（依那西普生物仿制药）的I期试验中给药，用于治疗类风湿性关节炎和其他自身免疫性疾病。

Clover制药首席执行官Joshua Liang说：“这个里程碑标志着Clover的第二个生物产品在几个月内启动人体临床试验。现在临床试验正积极招募多个国家的患者，中国的I期试验旨在评估皮下注射SCB-808和原研药依那西普在健康志愿者中的药代动力学，安全性和免疫原性的相似性。

Clover联合创始人，董事长兼总裁彭亮博士说：“在临床前研究中将SCB-808与依那西普进行了比较，我们相信，SCB-808与依那西普具有生物相似性，SCB-808的即用型注射预填充注射器配方将使我们具备重大的商业优势”。目前，中国的依那西普生物仿制药仅在冻干粉末制剂中被批准，其必须由受过训练的医务人员在皮下注射到患者体内。但是，SCB-808在预装注射器配方中开发，该注射器配方可以随时注射，并且可以由患者在他们自己的家中方便地自我管理。因此，在西方世界，即用型注射剂配方是绝大多数依那西普的剂型。因此，Clover制药的SCB-808有可能解决中国患者对这类药物未满足的医疗需求。


原始出处：

http://www.firstwordpharma.com/node/1582431#axzz5Mw2WiygQ

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    2019-01-27 rebeccajiejie

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    2018-08-04 zhouqu_8

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    2018-08-04 ms1490123962508630

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    2018-08-04 grace5701

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