We have received a Complete Response Letter (CRL) from the U.S. FDA regarding the approval application of SI-6603 for lumbar disc herniation treatment. There are no concerns about drug efficacy or safety; no additional clinical trials are required, but deficiencies in the manufacturing contractor led to the approval denial. We will consider resubmission in collaboration with licensing partner Felling Pharmaceuticals. Impact on the consolidated results for the fiscal year ending March 2027 is undecided.<\/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,"price_fetched_at":"","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":"4548","jir_company_name":"BioChem Industries Ltd.","jir_importance":"\u2605\u2605\u2605\u2606\u2606","jir_publication_date":"2026-09-10","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/09\/4548-20260910-01.pdf","jir_short_summary":"We have received a Complete Response Letter (CRL) from the U.S. FDA regarding the approval application of SI-6603 for lumbar disc herniation treatment. There are no concerns about drug efficacy or safety; no additional clinical trials are required, but deficiencies in the manufacturing contractor led to the approval denial. We will consider resubmission in collaboration with licensing partner Felling Pharmaceuticals. Impact on the consolidated results for the fiscal year ending March 2027 is undecided.","jir_summary":"### Neutral headline\nThis release announces that we have received a Complete Response Letter (CRL) from the FDA regarding the US approval application for SI-6603. The CRL mainly stems from findings at the API manufacturing facility and deficiencies identified during the cGMP inspection of a newly contracted finished drug manufacturer. There are no concerns about the efficacy or safety of the clinical data, and no additional clinical trials are required. We will proceed with the resubmission plan in collaboration with the licensee Felling Pharmaceuticals.\n\n### Financial outlook and future prospects\nThe impact of this matter on the consolidated earnings forecast for the fiscal year ending March 2027 is currently under review, and we will disclose promptly if there are any material items. As of now, specific numerical impacts are unknown, and we are pursuing a cautious disclosure approach.","jir_financial_highlights":"Unknown: Unknown (Unknown)","jir_category":"","jir_hashtags":"#BioChemIndustriesLtd, #DisclosureUpdate, #FDAReview, #ClinicalDevelopment, #ResubmissionPlanned","jir_key_figures":"Resubmission timing: Unknown\nReason for CRL: deficiencies at the API\/finished drug manufacturing contractor\nClinical data assessment: no efficacy\/safety concerns, no additional clinical trials required","jir_meta_title":"BioChem Industries Ltd. SI-6603 FDA Review Completion Notice Received | Considering Resubmission","jir_meta_description":"BioChem Industries Ltd. has received a US FDA review completion notice for SI-6603, a lumbar disc herniation treatment. The CRL was caused by deficiencies in the API and the finished-drug contract manufacturer. Additional clinical trials are not required, and we are coordinating with the licensing partner to move toward resubmission. Impact on the fiscal year ending March 2027 is yet to be determined.","jir_og_title":"BioChem Industries Ltd. SI-6603 FDA Review Completion Notice Received","jir_og_description":"Receipt of the FDA review completion notice for SI-6603. The issue stems from manufacturing-related deficiencies; no concerns over clinical data. Considering resubmission; impact on the fiscal year ending March 2027 is undetermined.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[]","ir_related_company":56853,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"disclosure_update","footnotes":""},"sector":[],"importance":[],"class_list":["post-112367","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n