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Other Disclosures4552JCR Pharmaceuticals Co.,Ltd.Pharmaceuticals

Iskargo, a blood-brain barrier-penetrating enzyme replacement therapy for Hunter syndrome, receives marketing approval in the United Arab Emirates

Marketing authorization has been obtained in the United Arab Emirates for Izcargo, a Hunter syndrome treatment that crosses the blood-brain barrier. This is the first approval outside Japan, and the company plans to pursue approvals in the MENA (Middle East and North Africa) region and sales by Taiba.

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Announced details

IZCARGO®Pabinafusp alfaJR-141J-Brain Cargo®
Applicable field (uses covered by this announcement)

Treatment of Hunter syndrome (mucopolysaccharidosis type II), rare disease care, and management of central nervous system symptoms

What the company reported numerically
Usage history

On sale in Japan since May 2021

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

The company has entered into a sales consignment agreement with Taiba. Taiba plans to sell this product in the United Arab Emirates and other MENA countries and regions.

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 orphan drugs in the MENA region. It has built relationships of trust over 20 years with clinicians, healthcare institutions and global partner companies.

Awarding / certifying body

Regulatory authority of the United Arab Emirates (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

Mol. Ther. 2018; 26(5):1366-1374

Mol. Ther. 2021; 29(5):1853-1861

Mol Ther. 2020; 27(2):456-464

Mol Ther. 2021; 29(2):671-679

Mol Ther. 2021; 29(7):2378-2386

Int. J. Mol. Sci. 2021, Volume 22, Issue 20, 10938

Announced details
ItemDetails
Names of Products / Services CoveredIZCARGO®, Pabinafusp alfa, 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 orphan drugs in the MENA region. It has built relationships of trust over 20 years with clinicians, healthcare institutions and global partner companies.
Relationship with the CompanyThe company has entered into a sales consignment agreement with Taiba. Taiba plans to sell this product in the United Arab Emirates and other MENA countries and regions.
Applicable areaTreatment of Hunter syndrome (mucopolysaccharidosis type II), rare disease care, and management of central nervous system symptoms
Awarding / certifying bodyRegulatory authority of the United Arab Emirates (name not disclosed)
Usage historyOn sale in Japan since May 2021
Impact on Business PerformanceThe impact on consolidated results for the fiscal year ending March 2027 will be immaterial.
SourceBased on the Company's research, Mol. Ther. 2018; 26(5):1366-1374, Mol. Ther. 2021; 29(5):1853-1861, Mol Ther. 2020; 27(2):456-464, Mol Ther. 2021; 29(2):671-679, Mol Ther. 2021; 29(7):2378-2386, Int. J. Mol. Sci. 2021, Volume 22, Issue 20, 10938
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.

To pursue international expansion by leveraging the marketing authorization already obtained in Japan. While advancing the global Phase III clinical trial, the company aims to make the treatment available to patients worldwide as soon as possible.

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Iskargo, a blood-brain barrier-penetrating enzyme replacement therapy for Hunter syndrome, receives marketing approval in the United Arab Emirates | JCR Pharmaceuticals Co.,Ltd. (4552) timely disclosure | Komori