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Chinese Regulator Approves Toray's REMITCH® Nalfurafine Hydrochloride Orally Disintegrating Tablets for Pruritus Relief

Jul. 5, 2023

Toray Industries, Inc.

Tokyo, Japan, July, 5, 2023 - Toray Industries, Inc., announced today that it has received approval from China's National Medical Products Administration (NMPA) for REMITCH® nalfurafine hydrochloride orally disintegrating tablets (see note 1). The company developed this antipruritus medication for hemodialysis patients who find that existing pruritus therapies and treatments offer insufficient efficacy.

Chinese integrated biotechnology company 3SBio Inc. will marketing and provide information about this tablet formulation in China (excluding in Hong Kong, Macao, and Taiwan). Toray and that company prepare to launch this offering in the first half of 2024.

Pruritus in hemodialysis patients is a generalized, intense itch without inflammation. Histamine commonly causes itching among people but is less of a factor in such cases. Antihistamines and other regular treatments for itching thus may not offer sufficient efficacy.

In China, the number of people with kidney disease is rising around 10% annually. Around 750,000 people there received hemodialysis in 2021. Moderate or severe pruritus afflicted around 39% of those patients. To date, China has had nothing to offer hemodialysis patients for whom existing pruritus therapies provide no relief.

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: Nalfurafine hydrochloride orally disintegrating tablets
Indication: Improves pruritus in hemodialysis patients for whom existing therapies or treatments are insufficiently efficacious.
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.

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
Establishment: January 1926
Representative: Mitsuo Ohya, President and Representative Director
Revenue: ¥2,489.3 billion in fiscal year ended March 31, 2023

Profile of 3SBio Inc.
Principal businesses: Development, import, manufacturing and selling pharmaceuticals, focusing on renal diseases (hemodialysis), oncology, autoimmune diseases (rheumatism), metabolic diseases (diabetes) and dermatological diseases
Headquarters: Shenyang, Liaoning Province, China
Establishment: 1993
Representative: Lou Jing, Chairman
Revenue: RMB 6859.4 million in 2022

Reference News Release
December 21, 2021
Toray and 3SBio File New Drug Application with Chinese Regulator for Orally Disintegrating Antipruritus Tablets
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Toray Industries Inc. published this content on 05 July 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 05 July 2023 09:08:07 UTC.