/PRNewswire/ -- NS Pharma, Inc. (NS Pharma) a subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku), announced today that the U.S. Food & Drug Administration (FDA) has granted Orphan Drug Designation to NS-229, which is being developed for the treatment of the rare disease eosinophilic granulomatosis with polyangiitis (EGPA).

/PRNewswire/ -- 日本新药株式会社（Nippon Shinyaku）旗下子公司NS Pharma, Inc.（NS Pharma）今日宣布，美国食品药品监督管理局（FDA）已授予NS-229孤儿药资格，该药物正在开发用于治疗罕见病嗜酸性肉芽肿性多血管炎（EGPA）。

NS-229 is being investigated as a selective Janus kinase 1 (JAK1) inhibitor to help regulate immune cell function and prevent the immune system from causing tissue damage..

NS-229 作为一种选择性 Janus 激酶 1 (JAK1) 抑制剂正在研究中，以帮助调节免疫细胞功能并防止免疫系统造成组织损伤。

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FDA Orphan Drug Designation status is granted for treatments of rare diseases affecting fewer than 200,000 people in the U.S. This designation provides NS Pharma with a seven-year market exclusivity period, in support of the company's continued development and evaluation of this therapy.

FDA孤儿药资格状态授予用于治疗美国境内影响不到20万人的罕见疾病的疗法。该资格为NS Pharma提供七年的市场独占期，以支持该公司对该疗法的持续开发和评估。

'Our therapy has been designed to target the specific enzyme associated with the inflammatory response in EGPA.'

“我们的疗法旨在针对与EGPA炎症反应相关的特定酶。”

About EGPA

关于EGPA

EGPA is a rare autoimmune disease causing inflammation in the small-to-medium-sized blood vessels which can cause tissue and organ damage to the lungs, sinuses, peripheral nerves, skin, and kidneys. EGPA is generally preceded by symptoms of bronchial asthma and allergic rhinitis. The cause is unknown.

EGPA是一种罕见的自身免疫性疾病，会导致中小血管发炎，从而可能对肺、鼻窦、周围神经、皮肤和肾脏造成组织和器官损伤。EGPA通常先出现支气管哮喘和过敏性鼻炎的症状，病因尚不清楚。

It is estimated that EGPA affects between 5,600 and 14,500 people in the U.S.*.

据估计，EGPA在美国影响的人数在5,600到14,500之间。*

'There are several factors associated with the inflammatory response in EGPA that could be regulated by JAK1,' explained NS Pharma Vice President, Research & Development,

“EGPA中的炎症反应与JAK1可能调控的几个因素相关，”NS Pharma研发副总裁解释道，

Takeshi Seita

瀬尾武志

. 'Our therapy has been designed to target this specific enzyme.'

“我们的治疗方法旨在针对这种特定的酶。”

A Phase 2 global study of NS-229 is being conducted by Nippon Shinyaku and NS Pharma.

日本新药株式会社和NS制药公司正在进行NS-229的第二阶段全球研究。

About NS Pharma, Inc.

关于NS制药公司

NS Pharma, Inc., is a wholly owned subsidiary of Nippon Shinyaku Co., Ltd. NS Pharma is a registered trademark of the Nippon Shinyaku group of companies. For more information, please visit

NS Pharma, Inc. 是日本新药株式会社（Nippon Shinyaku Co., Ltd.）的全资子公司。NS Pharma 是日本新药集团公司的注册商标。欲了解更多信息，请访问