2023年7月5日

5天改变今天上午05:09中国监管机构批准东丽REMITCH®Nalfurafine盐酸口腔崩解片缓解瘙痒7月5日,2023年东丽工业,Inc .东京,日本,7月5日,2023年东丽工业公司,今天宣布获得批准从中国的国家医疗产品管理局(NMPA) REMITCH®Nalfurafine盐酸口腔崩解片(见注1)。该公司开发这个antipruritus药物治疗血液透析患者发现现有瘙痒的治疗方法和治疗提供有效性不足。中国综合生物科技公司3 sbio公司将营销和提供这款平板电脑的信息制定在中国(不包括香港、澳门和台湾)。东丽,公司准备在2024年上半年推出该产品。血液透析患者瘙痒是广义的,没有炎症剧烈瘙痒。组胺通常会导致瘙痒的人,但是在这种情况下,更少的因素。抗组胺药和其他常规治疗瘙痒因此可能不会提供足够的功效。在中国,与肾脏疾病的人数每年增长约10%。大约750000人在2021年接受血液透析。中度或重度瘙痒折磨患者的39%左右。迄今为止,中国已没有提供血液透析患者来说,现有的瘙痒治疗提供没有缓解。 Toray developed this medication and received marketing approval in Japan under the trade name REMITCH®OD Tablets 2.5 μg (see note 2). Toray licensed this formulation to 3SBio in December 2017. In November 2021, the two companies lodged an import approval application with the NMPA, which recently issued its authorization. Toray and 3SBio submitted a clinical trial application to the NMPA for alleviating pruritus in people with chronic liver disease (limited to cases in which the efficacy of existing treatments is insufficient). The NMPA issued approval for the application in May this year. The two companies hope that the new treatment will serve as a new alternative for alleviating pruritus in China and enhance the quality of life for patients there. Overview of REMITCH approval in China Generic name: Dosage and Administration: The usual adult dosage of nalfurafine hydrochloride is 2.5 µg of once daily after an evening meal or before bedtime, with a maximum dose of 5 µg once daily. Notes: 1. Toray created nalfurafine hydrochloride (Toray development code: TRK-820), the active pharmaceutical ingredient in REMITCH® nalfurafine hydrochloride orally disintegrating tablets as the world's first highly selective kappa opioid receptor agonist. Toray developed REMITCH® nalfurafine hydrochloride orally disintegrating tablets by leveraging its RADIFIL® film coating technology, which offers superior light shielding, low friability, advanced extensibility, and rapid dissolution. People can take these orally disintegrating tablets with or without water, helping to enhance medication compliance among those finding it hard to swallow pills or people with fluid restrictions. 2. Torii Pharmaceutical Co., Ltd., distributes this agent in Japan to alleviate pruritus in dialysis patients and patients with chronic liver disease (only when efficacy from existing therapies or treatments is insufficient). Profile of Toray Industries, Inc. Principal businesses: Manufacturing, processing, and selling fibers and textiles, functional chemicals, carbon fiber composites, environment and engineering, life sciences, and other offerings Headquarters: Chuo-ku, Tokyo