Komori
Other Disclosures4565Nxera Pharma Co.,Ltd.Pharmaceuticals

Announces receipt of manufacturing and marketing approval in Taiwan for the insomnia treatment daridorexant

The Taiwanese authorities approved the manufacture and marketing of the Company's insomnia treatment QUVIVIQ® (daridorexant) 25 mg and 50 mg. Its partner, Holling Bio-Pharma Corp., plans to launch the products in Taiwan during 2026, and the Company will receive revenue from product supply, milestone payments, royalties and other sources.

Worth reading
70In focus
0–100. This measures how worthwhile something is to read, not how good or bad the company is.
Direction
Improvement
Direction inferred from the company’s description.
Scale
4000000
People (approximately 4 million to 5 million patients in Taiwan with insomnia and other sleep disorders)
Wording
Conditional
How definitive the wording is.

Announced details

QUVIVIQ® (daridorexant; Taiwan product name: 科唯可®) 25 mgQUVIVIQ® (daridorexant; Taiwan product name: 科唯可®) 50 mg
Applicable field (uses covered by this announcement)

Treatment of adult patients with insomnia

Launch dateScheduled for launch in Taiwan during 2026
Relationship between the counterparty and the company
Nxera Pharma Co.,Ltd.4565
Relationship with the Company

Partnership. The Company supplies the products, while Holling handles the application and approval process, distribution and sales.

CounterpartyHolling Bio-Pharma Corp. (Holling)

Taiwan's largest pharmaceutical distribution and sales company, headquartered in Taipei, with approximately 50 years of operating history. It provides pharmaceutical registration, market access, product promotion, warehouse management and logistics services, and has experience and expertise in the central nervous system field.

Location (as indicated in this announcement)

Taipei, Taiwan (Holling's headquarters)

Contract Value

Milestone amounts are undisclosed. The Company is entitled to receive initial sales-related milestone payments, royalties on net sales and revenue from product supply.

Impact on Business Performance

The impact on the Company's consolidated results for the fiscal year ending December 2026 has already been incorporated into the consolidated earnings forecast for the fiscal year disclosed on 13 February 2026.

The company does not address Offering price.

Source (materials cited by the company)

Taiwan's National Health Research Institutes (number and percentage of Taiwanese adults with insomnia and other sleep disorders in 2021)

Announced details
ItemDetails
Names of Products / Services CoveredQUVIVIQ® (daridorexant; Taiwan product name: 科唯可®) 25 mg, QUVIVIQ® (daridorexant; Taiwan product name: 科唯可®) 50 mg
CounterpartyHolling Bio-Pharma Corp. (Holling)
Counterparty overviewTaiwan's largest pharmaceutical distribution and sales company, headquartered in Taipei, with approximately 50 years of operating history. It provides pharmaceutical registration, market access, product promotion, warehouse management and logistics services, and has experience and expertise in the central nervous system field.
Relationship with the CompanyPartnership. The Company supplies the products, while Holling handles the application and approval process, distribution and sales.
Contract ValueMilestone amounts are undisclosed. The Company is entitled to receive initial sales-related milestone payments, royalties on net sales and revenue from product supply.
Launch dateScheduled for launch in Taiwan during 2026
Applicable areaTreatment of adult patients with insomnia
LocationTaipei, Taiwan (Holling's headquarters)
Impact on Business PerformanceThe impact on the Company's consolidated results for the fiscal year ending December 2026 has already been incorporated into the consolidated earnings forecast for the fiscal year disclosed on 13 February 2026.
SourceTaiwan's National Health Research Institutes (number and percentage of Taiwanese adults with insomnia and other sleep disorders in 2021)
Items this document does not state (8)
Offering priceContract DateAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocation scaleQuantitative EffectsUsage history

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 used materials from its Japanese marketing application and applied for the Taiwan Food and Drug Administration's (TFDA) Streamlined Review Designation.

How to read this page

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Announces receipt of manufacturing and marketing approval in Taiwan for the insomnia treatment daridorexant | Nxera Pharma Co.,Ltd. (4565) timely disclosure | Komori