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Other Disclosures4552JCR Pharmaceuticals Co.,Ltd.Pharmaceuticals

Notice of Obtaining Manufacturing and Marketing Approval in Kuwait for IZCARGO, a Blood-Brain Barrier-Penetrating Enzyme Therapy for Hunter Syndrome

Conditional marketing approval was obtained in Kuwait for Izkargo, a blood-brain barrier-penetrating treatment for Hunter syndrome. Following Japan and the United Arab Emirates, Kuwait is the second country outside Japan to grant approval.

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Announced details

Izkargo® (generic name: pabinafusp alfa; development code: JR-141)J-Brain Cargo®
Applicable field (uses covered by this announcement)

Treatment of Hunter syndrome (mucopolysaccharidosis type II); sales and distribution in the MENA (Middle East and North Africa) region

What the company reported numerically
Usage history

Sold in Japan since May 2021. Kuwait is the second country outside Japan to grant approval.

Relationship between the counterparty and the company
JCR Pharmaceuticals Co.,Ltd.4552
Relationship with the Company

The company has entered into a distribution agreement covering the MENA region.

CounterpartyTaiba Middle East FZ LLC

Headquartered in the United Arab Emirates. CEO: Saif Al Hasani. The company is responsible for the marketing, sales and distribution of treatments for rare diseases in the MENA region. It has built 20-year relationships with clinicians, healthcare institutions and global partner companies.

Awarding / certifying body

Kuwait’s regulatory authority (name: Not disclosed)

Impact on Business Performance

The impact on consolidated results for the fiscal year ending March 2027 will be immaterial.

The company does not address Contract Value / Offering price.

Source (materials cited by the company)

Based on the company’s research; 6 papers published in Mol. Ther. and Int. J. Mol. Sci. are cited as reference literature

Announced details
ItemDetails
Names of Products / Services CoveredIzkargo® (generic name: pabinafusp alfa; development code: JR-141), J-Brain Cargo®
CounterpartyTaiba Middle East FZ LLC
Counterparty overviewHeadquartered in the United Arab Emirates. CEO: Saif Al Hasani. The company is responsible for the marketing, sales and distribution of treatments for rare diseases in the MENA region. It has built 20-year relationships with clinicians, healthcare institutions and global partner companies.
Relationship with the CompanyThe company has entered into a distribution agreement covering the MENA region.
Applicable areaTreatment of Hunter syndrome (mucopolysaccharidosis type II); sales and distribution in the MENA (Middle East and North Africa) region
Awarding / certifying bodyKuwait’s regulatory authority (name: Not disclosed)
Usage historySold in Japan since May 2021. Kuwait is the second country outside Japan to grant approval.
Impact on Business PerformanceThe impact on consolidated results for the fiscal year ending March 2027 will be immaterial.
SourceBased on the company’s research; 6 papers published in Mol. Ther. and Int. J. Mol. Sci. are cited as reference literature
Items this document does not state (9)
Contract ValueOffering priceContract DateLaunch dateAward/certification nameRegistration number and expiry dateLocationLocation scaleQuantitative Effects

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

The company's own explanation, not something inferred from the numbers.

The company is pursuing approval under a distribution agreement with Taiba to leverage the marketing approval already obtained in Japan and develop its business in the MENA region. It also aims to expand treatment options for patients with Hunter syndrome, a rare disease.

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Notice of Obtaining Manufacturing and Marketing Approval in Kuwait for IZCARGO, a Blood-Brain Barrier-Penetrating Enzyme Therapy for Hunter Syndrome | JCR Pharmaceuticals Co.,Ltd. (4552) timely disclosure | Komori