Shionogi & Co., Ltd. has applied for manufacturing and marketing approval of the 0.5% lotion formulation of the atopic dermatitis treatment “Collectim\u00ae.” Safety and bioequivalence were confirmed through Phase 1 skin safety and Phase 3 bioequivalence studies.<\/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":"4507","jir_company_name":"Shionogi & Co., Ltd.","jir_importance":"\u2605\u2605\u2605\u2605\u2606","jir_publication_date":"2026-02-27","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/02\/4507-20260227-01.pdf","jir_short_summary":"Shionogi & Co., Ltd. has applied for manufacturing and marketing approval of the 0.5% lotion formulation of the atopic dermatitis treatment \"Collectim\u00ae.\" Safety and bioequivalence were confirmed through Phase 1 skin safety and Phase 3 bioequivalence studies.","jir_summary":"### Product Overview and Application Details\nShionogi & Co., Ltd. and Torii Pharmaceutical Co., Ltd. have applied for manufacturing and marketing approval of the 0.5% lotion formulation as a new dosage form of the atopic dermatitis treatment \"Collectim\u00ae.\" Collectim\u00ae is a JAK inhibitor that is already approved as an ointment for atopic dermatitis in adults, children, and infants. This lotion formulation has confirmed bioequivalence with the ointment and features easy application to the scalp and hairy areas.\n\n### Clinical Trial Results and Future Outlook\nSafety and bioequivalence were confirmed as favorable in Phase 1 skin safety and Phase 3 bioequivalence studies. The lotion has a less sticky texture and favorable usability, expected to contribute to improved patient treatment adherence. Shionogi aims to enhance patients\u2019 quality of life and is committed to early product availability.","jir_financial_highlights":"Manufacturing and Marketing Approval Application: 0.5% Lotion Formulation (Application for new formulation addition)\nClinical Trial Results: Favorable Phase 1 skin safety and Phase 3 bioequivalence study results (Confirmed safety and bioequivalence)\nIndications: Atopic Dermatitis (Adults, Pediatrics, Infants) (Expected expansion of usage range with lotion formulation addition)","jir_category":"","jir_hashtags":"#Shionogi, #product_announcement, #JapaneseStocks","jir_key_figures":"Lotion Concentration: 0.5%\nPhase 1 Skin Safety Study: Confirmed favorable safety\nPhase 3 Bioequivalence Study: Confirmed bioequivalence with ointment formulation","jir_meta_title":"Shionogi Applies for Manufacturing and Marketing Approval of 0.5% Lotion Formulation of Atopic Dermatitis Treatment \"Collectim\u00ae\"","jir_meta_description":"Shionogi announces application for manufacturing and marketing approval of 0.5% lotion formulation of atopic dermatitis treatment \"Collectim\u00ae.\" Safety and bioequivalence confirmed in Phase 1 and Phase 3 trials, with expectations to improve patient treatment adherence.","jir_og_title":"Shionogi Announces Approval Application for Collectim\u00ae 0.5% Lotion Formulation","jir_og_description":"Applied for manufacturing and marketing approval of new lotion formulation 0.5% of atopic dermatitis treatment \"Collectim\u00ae,\" confirming safety and bioequivalence.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[]","ir_related_company":6919,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"product_announcement","footnotes":""},"sector":[],"importance":[],"class_list":["post-31709","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n