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Mabion S.A. — Investor Relations & Filings

Ticker · MAB ISIN · PLMBION00016 LEI · 259400KG5JVQPPZL6X53 WAR Manufacturing
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Filings indexed 1,002 across all filing types
Latest filing 2019-09-13 Interim / Quarterly Rep…
Country PL Poland
Listing WAR MAB

About Mabion S.A.

https://www.mabion.eu/en/

Mabion S.A. is an integrated Contract Development and Manufacturing Organization (CDMO) that provides end-to-end services for the development and manufacturing of protein-based biotherapeutics. The company specializes in monoclonal antibodies and biosimilars, offering a complete workflow from cell line development and banking to process optimization and large-scale GMP manufacturing. Core competencies include upstream processing using mammalian cell cultures, downstream purification involving chromatography and viral clearance, and technology transfer for scale-up. Mabion partners with pharmaceutical and biotechnology companies to support both clinical and commercial supply, streamlining the path from gene to final drug product.

Recent filings

Filing Released Lang Actions
Mabion_Sprawozdanie Zarządu
Interim / Quarterly Report Classification · 100% confidence The document is a 'Sprawozdanie Zarządu z działalności' (Management Board Report on Activities) for Mabion S.A. for the first half of 2019. It contains detailed financial data, balance sheets, profit and loss statements, and management commentary for a period shorter than a full fiscal year. It is not an announcement of a report, but the report itself, containing substantive financial information. Therefore, it is classified as an Interim/Quarterly Report. H1 2019
2019-09-13 Polish
Mabion MSSF_1H2019
Interim / Quarterly Report Classification · 100% confidence The document is a 'Śródroczne Skrócone Sprawozdanie Finansowe' (Interim Condensed Financial Statement) for Mabion S.A. for the 6-month period ending June 30, 2019. It contains detailed financial statements, including the Statement of Comprehensive Income, Statement of Financial Position, and Statement of Cash Flows. As it provides comprehensive financial data for an interim period, it is classified as an Interim/Quarterly Report. H1 2019
2019-09-13 Polish
Uzyskanie certyfikatu GMP dla Kompleksu w Konstantynowie Łódzkim w zakresie wytwarzania produktu leczniczego - Content (PL)
Regulatory Filings Classification · 95% confidence The document is a formal announcement by the Management Board ("Zarząd") of Mabion S.A. regarding the receipt of a GMP (Good Manufacturing Practice) certificate from the Chief Pharmaceutical Inspectorate ("GIF"). This relates to the company's manufacturing operations for a specific product (MabionCD20). This type of announcement, detailing regulatory compliance or operational milestones that are not standard financial reports (10-K, IR) or management changes (MANG), falls best under a general regulatory announcement or a specific operational update. Since it is a formal notification of a significant regulatory/operational achievement necessary for commercialization, and it doesn't fit perfectly into the other specific categories (like DIRS, DIV, CAP, etc.), it is classified as a general Regulatory Filing (RNS). The document length is short (1566 chars), but it contains the core information rather than just announcing an attachment, so RPA is less appropriate than RNS for this specific regulatory milestone notification.
2019-08-19 Polish
Informacja dotycząca współpracy z Mylan - Content (PL)
M&A Activity Classification · 99% confidence The document text is very short (828 characters) and discusses an update regarding a potential merger (Mylan NV/Upjohn) and its impact on an existing agreement (Development and Commercialization Agreement) previously announced in a 'raport bieżący' (current report). It explicitly states that the company will inform the market via a 'raport bieżący' if significant changes occur. This structure—providing a brief update on a corporate event (merger/agreement status) and referencing future required disclosures—is characteristic of a general regulatory announcement that doesn't fit the specific financial report categories (10-K, IR, ER) or specific corporate actions (DIV, SHA, DIRS). Given the nature of providing an update on a corporate development (potential M&A impact) that is not a formal financial statement or a specific governance filing, the most appropriate fallback category is Regulatory Filings (RNS).
2019-08-14 Polish
Rejestracja zmiany Statutu Spółki - Content (PL)
AGM Information Classification · 99% confidence The document is a formal announcement from the Management Board ("Zarząd") of Mabion S.A. regarding the registration of amendments to the Company's Articles of Association ("Statutu Spółki") by the National Court Register (KRS). The amendments detail changes to the company's business scope (PKD codes) and significant governance structures, specifically concerning the Supervisory Board (§21) and its committees (§25), including the Audit Committee. Changes to the Articles of Association are fundamental corporate governance events, often requiring shareholder approval (as indicated by the reference to the Extraordinary General Meeting on June 18, 2019). This type of filing, which reports on structural or governance changes documented in official registers, fits best under Governance Information (CGR), as it directly relates to the company's internal rules and structure, rather than a specific financial report (like 10-K or IR) or a management change (MANG). It is not a proxy statement (PSI) or a general regulatory filing (RNS) because it concerns a specific, substantive change in corporate charter.
2019-08-06 Polish
Informacja od Europejskiej Agencji Leków nt. oceny wyniku inspekcji GMP w zakresie wytwarzania leku MabionCD20 w Kompleksie w Konstantynowie Łódzkim - Content (PL)
Regulatory Filings Classification · 95% confidence The document text is a formal announcement from the Management Board (Zarząd) of Mabion S.A. It details receiving correspondence from the European Medicines Agency (EMA) regarding a successful pre-authorization inspection by the Chief Pharmaceutical Inspectorate concerning GMP compliance for a specific drug candidate (MabionCD20). This information relates to regulatory compliance and the path to drug approval, which is a significant legal/regulatory event for a pharmaceutical company. It is not a standard financial report (10-K, IR, ER), a management change (MANG), or a director's trade (DIRS). Since it concerns a specific regulatory finding and its impact on product approval, it fits best under the general category for significant regulatory announcements that aren't explicitly covered elsewhere, such as legal proceedings or specific financial events. Given the options, 'Regulatory Filings' (RNS) is the most appropriate fallback for a specific, non-standard regulatory update that doesn't fit the other defined categories like LTR (Legal Proceedings) or CAP (Financing). However, because it is a specific update on a regulatory inspection outcome critical to product authorization, it is a significant regulatory event. Since there is no specific 'Regulatory Approval Update' category, RNS serves as the best fit for a general regulatory announcement.
2019-07-25 Polish

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