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    3402   JP3621000003

TORAY INDUSTRIES, INC.

(3402)
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Toray Industries : Receives Approval from China's NMPA for Careload« to Treat Pulmonary Arterial Hypertension

09/27/2022 | 10:16pm EST
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  • Toray Receives Approval from China's NMPA for Careload® to Treat Pulmonary Arterial Hypertension
Toray Receives Approval from China's NMPA for Careload® to Treat Pulmonary Arterial Hypertension

Sep. 28, 2022

Toray Industries, Inc.
Shenzhen Main Luck Pharmaceuticals Inc.


Tokyo, Japan, September 28, 2022 - Toray Industries, Inc., announced today that it has received approval from China's National Medical Products Administration (NMPA) (see explanatory note 1) for Careload® tablets to treat pulmonary arterial hypertension. Careload® is a proprietary orally administered sustained-release formulation of beraprost sodium, a derivative of prostacyclin (PGI2) (explanatory note 2).

Shenzhen Main Luck Pharmaceuticals Inc. will sell and provide information about this offering in all areas of mainland China. Toray and Shenzhen Main Luck Pharmaceuticals are preparing to launch Careload® in early 2023.

Pulmonary arterial hypertension is high blood pressure in the arteries suppling the lungs, a disorder caused by abnormalities in those arteries. It is hard to detect in early stages. The disease has often progressed significantly by the time shortness of breath, fatigue and other symptoms become noticeable. In advanced stages, it can cause heart failure.

Toray created Careload® and obtained approval in Japan in 2007 for it to treat pulmonary arterial hypertension. The NMPA added this agent to its "urgently needed" list in 2019. The list covers overseas drugs for life-threatening orphan diseases (explanatory note 3). Toray and Shenzhen Main Luck Pharmaceuticals applied in April 2020 for Careload® as a pulmonary arterial hypertension treatment option in mainland China, and received approval as previously mentioned

The two companies look forward to helping improve the quality of life for sufferers of this disease in that market.

Summary of approval in China
Brand Name: Careload®
Generic name: Beraprost sodium sustained-release tablets
Indication: For the treatment of pulmonary arterial hypertension of WHO Function Class I-III (PAH, WHO Group I) to improve the exercise capacity of patients.
Dosage and Administration: The usual dosage for adults should start at 120 micrograms per day, administered orally in 2 divided doses (after breakfast and dinner), with the dosage gradually increasing while carefully monitoring patients for possible symptoms (side effects). Dosages can be adjusted according to symptoms and tolerability, with a maximum daily dosage of 360 micrograms, administered orally in 2 divided doses (after breakfast and dinner).

Explanatory notes
1. China's National Medical Products Administration
This government agency oversees examinations and approvals of pharmaceuticals and medical devices to be sold in China.
2. A prostacyclin (PGI2) derivative sustained-release formulation
There are three different pathways for pulmonary vasodilators for treating pulmonary arterial hypertension: the prostacyclin (PGI2) pathway, the endothelin pathway, and the nitric oxide pathway. A prostacyclin (PGI2) derivative sustained-release formulation stabilized prostacyclin by making it a derivative. Furthermore, Toray developed a formulation which can adjust drug releases to maintain its efficacy.
3. "Urgently needed" list
Drugs on this list must fulfill all the following conditions:
New treatments marketed overseas but not in China for orphan diseases.
New drugs for diseases that severely threaten lives or the quality of life and for which there is no effective treatment or which are clinically superior.

Corporate Profiles

Toray Industries, Inc.
Establishment: January 1926
Head office: Chuo Ward, Tokyo
Revenue: ¥2,228.5 billion yen (in fiscal year 2021)
Businesses: Manufacturing and selling fibers and textiles, performance chemicals, carbon fiber composite materials, environment and engineering, life science, and others
Website: https://www.toray.com/global/

Shenzhen Main Luck Pharmaceuticals Inc.
Establishment: July 1990
Head office: Pingshan District, Shenzhen, Guangdong Province, China
Revenue: 1.2 billion yuan (in fiscal year 2021)
Businesses: Researching & developing, manufacturing, and selling active pharmaceutical ingredients and formulations for oncology, cardiovascular diseases, anesthetics and analgesics, and respiratory ailments, and importing and exporting pharmaceuticals and related technologies.
Website: http://www.wanle.com.cn/


Disclaimer

Toray Industries Inc. published this content on 28 September 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 28 September 2022 02:15:05 UTC.


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