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Daewoong Pharmaceutical Co.,Ltd sell "Luphere Depot"

基本信息

927
62
7
4.4(36)

交易类型

出售

产品名称

Luphere Depot

规格参数

  • 剂型: GnRH激动剂长效注射混悬剂,提供美国市场1个月、3个月和4个月制剂,以及日本市场1个月和3个月制剂。
  • 适应症: 适用于前列腺癌、子宫内膜异位症、子宫肌瘤、绝经后乳腺癌及中枢性性早熟。
  • 储存条件: 冷藏储存于2-8°C,避光保存,符合亮丙瑞林长效制剂的常规储存要求。

其他信息

补充描述:

Luphere Depot, a leuprorelin-based generic equivalent to Lupron/Leuplin, has been sold in Korea since January 2005 and is being developed for the US and Japanese markets. Acting as a GnRH agonist, it is indicated for prostate cancer, endometriosis, uterine fibroids, postmenopausal breast cancer, and central precocious puberty, with 1-, 3-, and 4-month US formulations and 1- and 3-month Japan formulations already researched. The sustained-release depot uses PLGA polymer encapsulation, matches the reference product's pharmacodynamic profile, and is produced in a cGMP facility; the company is seeking an overseas partner to handle bioequivalence studies, registration, and commercialization outside Korea.
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