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Other Disclosures4886ASKA Pharmaceutical Holdings Co.,Ltd.Pharmaceuticals

Notice of initiation of a domestic Phase III clinical trial for drospirenone product (LPRI-CF113): randomized controlled trial directly comparing progestin products for dysmenorrhea

ASKA Pharmaceutical has initiated a domestic Phase III clinical trial of drospirenone product LPRI-CF113, licensed in from Insud Pharma, for dysmenorrhea. This is a randomized controlled trial directly comparing it with the existing progestin product dienogest.

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Announced details

Drospirenone product (LPRI-CF113)PROFILE-D
Applicable field (uses covered by this announcement)

Dysmenorrhea

Launch dateDomestic Phase III clinical trial initiated on 4 November 2026 (actual)
Relationship between the counterparty and the company
ASKA Pharmaceutical Holdings Co.,Ltd.4886
Relationship with the Company

ASKA Pharmaceutical has licensed in this product from Insud Pharma.

CounterpartyInsud Pharma

Headquartered in Madrid, Spain. Insud Pharma has operated in the pharmaceutical and healthcare sectors for more than 45 years and has 9,000 employees worldwide. It develops and manufactures pharmaceuticals and pharmaceutical ingredients through 3 business units: Industrial (Chemo), Branded (Exeltis), and Biotechnology (mAbxience).

Location (as indicated in this announcement)

9,000 Insud Pharma employees

Impact on Business Performance

The impact on consolidated results for the fiscal year ending March 2027 has already been incorporated.

The company does not address Contract Value / Offering price.

Announced details
ItemDetails
Names of Products / Services CoveredDrospirenone product (LPRI-CF113), PROFILE-D
CounterpartyInsud Pharma
Counterparty overviewHeadquartered in Madrid, Spain. Insud Pharma has operated in the pharmaceutical and healthcare sectors for more than 45 years and has 9,000 employees worldwide. It develops and manufactures pharmaceuticals and pharmaceutical ingredients through 3 business units: Industrial (Chemo), Branded (Exeltis), and Biotechnology (mAbxience).
Relationship with the CompanyASKA Pharmaceutical has licensed in this product from Insud Pharma.
Launch dateDomestic Phase III clinical trial initiated on 4 November 2026 (actual)
Applicable areaDysmenorrhea
Location scale9,000 Insud Pharma employees
Impact on Business PerformanceThe impact on consolidated results for the fiscal year ending March 2027 has already been incorporated.
Items this document does not state (10)
Contract ValueOffering priceContract DateAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocationQuantitative EffectsUsage historySource

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 directly compare the efficacy and safety of this product with those of an existing progestin product. Through the development of this product, ASKA Pharmaceutical aims to create a new treatment option for dysmenorrhea and contribute to improving women's health and quality of life.

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