{"id":40695,"date":"2026-04-14T16:54:49","date_gmt":"2026-04-14T07:54:49","guid":{"rendered":"https:\/\/japanir.jp\/en\/ir\/4565-20260414-01_wp_product_announcement\/"},"modified":"2026-04-14T16:54:49","modified_gmt":"2026-04-14T07:54:49","slug":"4565-20260414-01_wp_product_announcement","status":"publish","type":"ir_release","link":"https:\/\/japanir.jp\/en\/company\/company-4565\/ir\/4565-20260414-01_wp_product_announcement\/","title":{"rendered":"Announcement of Approval for Manufacturing and Marketing Authorization of Insomnia Treatment Drug Daridorexant in Taiwan"},"content":{"rendered":"<p>Obtained manufacturing and marketing authorization for insomnia treatment drug Daridorexant (QUVIVIQ\u00ae) in Taiwan; partner Holling Bio-Pharma Corp. scheduled to launch within 2026. Milestone payments and royalty revenues are expected.<\/p>\n","protected":false},"comment_status":"open","ping_status":"closed","template":"","meta":{"Ticker":"","DATE":"","longName":"","company_name_ja":"","fullTimeEmployees":0,"address":"","phone":"","website":"","industry":"","sector":"","regularMarketPrice":0,"financialCurrency":"","marketCap":0,"fiftyTwoWeekLow":0,"fiftyTwoWeekHigh":0,"epsTrailingTwelveMonths":0,"epsForward":0,"bookValue":0,"totalRevenue":0,"OperatingIncome":0,"operatingMargins":0,"NetIncome":0,"profitMargins":0,"ebitda":0,"trailingPE":0,"forwardPE":0,"priceToBook":0,"returnOnEquity":0,"recommendationMean":0,"recommendationKey":"","targetMeanPrice":0,"numberOfAnalystOpinions":0,"analyst_earnings_data":"","dividendRate":0,"dividendYield":0,"payoutRatio":0,"totalEsg":0,"environmentScore":0,"socialScore":0,"governanceScore":0,"title":"","providerPublishTime":"","link":"","longBusinessSummary":"","longBusinessSummary_ja":"","quarterly_revenue":0,"quarterly_net_income":0,"quarterly_operating_profit":0,"enterprise_value":0,"company_officer_1_name":"","company_officer_1_title":"","company_officer_2_name":"","company_officer_2_title":"","company_officer_3_name":"","company_officer_3_title":"","company_officer_4_name":"","company_officer_4_title":"","company_officer_5_name":"","company_officer_5_title":"","company_officers_update_time":"","get_dividend_history_year1":0,"get_dividend_history_year2":0,"get_dividend_history_year3":0,"get_dividend_history_year4":0,"get_dividend_history_year5":0,"get_dividend_history_year6":0,"get_dividend_history_year7":0,"get_dividend_history_year8":0,"get_dividend_history_year9":0,"get_dividend_history_year10":0,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"jir_stock_code":"4565","jir_company_name":"Nexelpha Pharma, Inc.","jir_importance":"\u2605\u2605\u2605\u2605\u2606","jir_publication_date":"2026-04-14","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/04\/4565-20260414-01.pdf","jir_short_summary":"Obtained manufacturing and marketing authorization for insomnia treatment drug Daridorexant (QUVIVIQ\u00ae) in Taiwan; partner Holling Bio-Pharma Corp. scheduled to launch within 2026. Milestone payments and royalty revenues are expected.","jir_summary":"### Product Approval and Sales Framework\nNexelpha Pharma, Inc. announces that its partner in Taiwan, Holling Bio-Pharma Corp., has obtained manufacturing and marketing authorization for the insomnia treatment drug Daridorexant (QUVIVIQ\u00ae) from the Taiwan Food and Drug Administration (TFDA). Holling is responsible for application, approval, distribution, and sales, while Nexelpha Pharma will supply the formulation and receive royalty revenues under the contract. Utilizing Taiwan's priority review system, the product is scheduled for launch within 2026.\n\n### Business Strategy and Impact on Performance\nThe approval in Taiwan marks a significant milestone in the strategy to expand access to innovative specialty pharmaceuticals in the APAC region. Entering a market with an estimated patient population of approximately 4 to 5 million, milestone payments and royalty revenues are anticipated. This is already reflected in the consolidated earnings guidance for the fiscal year ending December 2026. Going forward, we will continue close collaboration with our partner to ensure smooth commercialization and market expansion.","jir_financial_highlights":"Milestone Income: Undisclosed (Unknown)\nScheduled Sales Launch: Within 2026 (New Market Entry)\nTarget Market Patient Population: Approximately 4 to 5 million (Unknown)","jir_category":"","jir_hashtags":"#NexelphaPharma, #NewDrugApproval, #InsomniaTreatment, #TaiwanMarket, #ProductAnnouncement","jir_key_figures":"Number of Insomnia Patients in Taiwan Market: Approximately 4 to 5 million\nDate of Manufacturing and Marketing Authorization: April 14, 2026\nScheduled Sales Launch: Within 2026","jir_meta_title":"[Nexelpha Pharma] Approval for Insomnia Treatment Drug Daridorexant obtained in Taiwan | April 2026","jir_meta_description":"Nexelpha Pharma has obtained manufacturing and marketing authorization for the insomnia treatment drug Daridorexant (QUVIVIQ\u00ae) in Taiwan. Partner Holling Bio-Pharma Corp. is scheduled to launch the product within 2026, with milestone payments and royalty revenues expected.","jir_og_title":"[Nexelpha Pharma] Insomnia Treatment Drug Approval Obtained in Taiwan | April 2026","jir_og_description":"Announcement of approval for insomnia treatment drug Daridorexant in the Taiwan market. Launch is planned within 2026, aiming for revenue expansion.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[]","ir_related_company":16880,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"product_announcement","footnotes":""},"sector":[],"importance":[],"class_list":["post-40695","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Announcement of Approval for Manufacturing and Marketing Authorization of Insomnia Treatment Drug Daridorexant in Taiwan - Japan IR<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/japanir.jp\/en\/company\/company-4565\/ir\/4565-20260414-01_wp_product_announcement\/\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/japanir.jp\/en\/company\/company-4565\/ir\/4565-20260414-01_wp_product_announcement\/\",\"url\":\"https:\/\/japanir.jp\/en\/company\/company-4565\/ir\/4565-20260414-01_wp_product_announcement\/\",\"name\":\"Announcement of Approval for Manufacturing and Marketing Authorization of Insomnia Treatment Drug Daridorexant in Taiwan - 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