Komori
Other Disclosures4547KISSEI PHARMACEUTICAL CO.,LTD.Pharmaceuticals

Yselty Receives Approval for an Additional Indication for Endometriosis in Taiwan

In Taiwan, approval was obtained for an additional indication allowing イセルティ (linzagolix), marketed by Synmosa Biopharma Corporation, to be used for endometriosis in addition to uterine fibroids. This makes the product available as a treatment option for endometriosis in Taiwan.

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Announced details

イセルティ (generic name: linzagolix)
Applicable field (uses covered by this announcement)

Endometriosis; gynecology

Launch dateAs of 11 November 2026, an additional indication for endometriosis in Taiwan had been obtained. The launch date for the endometriosis indication is Not disclosed.
Contract DateNovember 2022 (development and sales rights in Taiwan licensed)
Relationship between the counterparty and the company
KISSEI PHARMACEUTICAL CO.,LTD.4547
Relationship with the Company

The company has licensed Synmosa Biopharma Corporation the development and sales rights for イセルティ (linzagolix) in Taiwan.

CounterpartySynmosa Biopharma Corporation (ticker: TW.4114)

A Taiwanese listed company, established in 1980 and headquartered in Taiwan. Its chairman is Peter C.H. Lin. The company focuses on therapeutic areas including cardiovascular, respiratory, gynecology, urology, oncology and the central nervous system, and conducts research and development, manufacturing, contract manufacturing, sales and distribution of pharmaceuticals and health foods.

Awarding / certifying body

Taiwan Food and Drug Administration (TFDA)

Location (as indicated in this announcement)

Taiwan (Synmosa Biopharma Corporation headquarters)

Impact on Business Performance

Already reflected in the consolidated earnings forecast for the fiscal year ending March 2027.

The company does not address Contract Value / Offering price.

Announced details
ItemDetails
Names of Products / Services Coveredイセルティ (generic name: linzagolix)
CounterpartySynmosa Biopharma Corporation (ticker: TW.4114)
Counterparty overviewA Taiwanese listed company, established in 1980 and headquartered in Taiwan. Its chairman is Peter C.H. Lin. The company focuses on therapeutic areas including cardiovascular, respiratory, gynecology, urology, oncology and the central nervous system, and conducts research and development, manufacturing, contract manufacturing, sales and distribution of pharmaceuticals and health foods.
Relationship with the CompanyThe company has licensed Synmosa Biopharma Corporation the development and sales rights for イセルティ (linzagolix) in Taiwan.
Contract DateNovember 2022 (development and sales rights in Taiwan licensed)
Launch dateAs of 11 November 2026, an additional indication for endometriosis in Taiwan had been obtained. The launch date for the endometriosis indication is Not disclosed.
Applicable areaEndometriosis; gynecology
Awarding / certifying bodyTaiwan Food and Drug Administration (TFDA)
LocationTaiwan (Synmosa Biopharma Corporation headquarters)
Impact on Business PerformanceAlready reflected in the consolidated earnings forecast for the fiscal year ending March 2027.
Items this document does not state (8)
Contract ValueOffering priceAward/certification nameRegistration number and expiry dateLocation scaleQuantitative 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.

The Taiwan Food and Drug Administration (TFDA) granted an additional indication for endometriosis. The company explained that the approval is expected to provide a new treatment option for patients with endometriosis in Taiwan.

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Yselty Receives Approval for an Additional Indication for Endometriosis in Taiwan | KISSEI PHARMACEUTICAL CO.,LTD. (4547) timely disclosure | Komori