BioNxt Signs Letter of Intent With Gen-Plus GmbH & Co KG for Potential Business Collaborations
BioNxt Signs Letter of Intent With Gen-Plus GmbH & Co KG for Potential Business Collaborations
VANCOUVER, BC / ACCESSWIRE / August 15, 2024 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT) is pleased to report that it has signed a non-binding letter of intent (the "LOI") with German-based international contract research, development, and manufacturing company Gen-Plus GmbH & Co KG ("Gen-Plus"), a part of Conscio Group.
BioNxt Solutions Inc.(「BioNxt」或「公司」)(CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT)很高興宣佈已與總部位於德國的國際合同研究、開發和製造公司Gen-Plus GmbH & Co KG(「Gen-Plus」), Conscio集團的一部分,簽署了一份非約束性意向書(「LOI」)。
Further to the Master Service Agreement and Cladribine Statement of Work signed by BioNxt and Gen-Plus announced on July 9, 2024, and July 17, 2024, respectively, the LOI recognizes a number of important areas of potential cooperation between the parties, including but not limited to intellectual property and prototype development for new pharmaceutical products, clinical trial planning and batch manufacturing, laboratory, equipment, and office collaboration, business development, and thin film commercial manufacturing. The Company will provide further details on specific cooperation programs as they progress.
根據BioNxt和Gen-Plus於2024年7月9日和7月17日分別簽署的主服務協議和Cladribine工作聲明,LOI認可了雙方在多個重要領域開展潛在合作的可能性,包括但不限於新藥物產品的知識產權和原型開發、臨床試驗規劃和批量製造、實驗室、設備和辦公室合作、業務拓展以及薄膜商業製造。公司將在合作計劃具體進展後提供進一步的詳細信息。
Gen-Plus, a part of Conscio Group, has a head office in Munich, Germany, and through the Conscio Group operates within an international network of pharmaceutical service providers with facilities in five countries and over 500 employees. They offer GCP/GLP/GMP/ISO/IEC-certified services and GMP certified manufacturing of clinical trial supplies (Phase I-III) with a specialization in solids, semi-solids, liquids, oral films, and transdermal patches as well as integrated lab analytical services during development & GMP manufacturing, including API characterization, method development, optimization, validation, permeation studies, stabilities studies, etc.
總部位於德國慕尼黑的Conscio Group旗下的Gen-Plus在全球範圍內有五個國家的設施和超過500名員工,爲GCP/GLP/GMP/ISO/IEC認證的服務和藥物製造提供認證,包括臨床試驗用藥品的GMP認證(第I-III階段),專注於固體、半固體、液體、口服薄膜、透皮貼片及GMP製造期間的綜合實驗室分析服務,包括API表徵、方法開發、優化、驗證、過滲性研究、穩定性研究等
BioNxt is developing a 100% owned and proprietary ODF Cladribine dosage form, directed at the multiple sclerosis ("MS") market. Cladribine tablets are currently approved for use in over 75 countries, including by the United States Food and Drug Administration ("FDA") and the European Medicines Agency ("EMA"), with annual sales in excess of one billion USD. Cladribine tablets are approved for several indications, namely highly active forms of relapsing-remitting MS and certain forms of leukemia. MS represents the largest market segment for the sale of Cladribine with approximately 2.3 million people living with MS worldwide, with the highest prevalence in North America and Europe, noted by Atlas of MS. The global Multiple Sclerosis drug market is expected to top USD 41 billion by 2033 according to Market.us.
BioNxt正在開發100%自有和專有的ODF Cladribine劑量形式,用於多發性硬化("MS")市場。Cladribine片目前已獲得超過75個國家的批准,包括美國食品和藥品管理局("FDA")和歐洲藥品管理局("EMA"),年銷售額超過10億美元。Cladribine片獲批幾種適應症,即高度活動的復發緩解型MS和某些形式的白血病。多發性硬化是Cladribine銷售的最大市場細分,全球大約有230萬人患有MS,在北美和歐洲的患病率最高,據MS地圖所述。根據Market.us,全球多發性硬化藥物市場預計到2033年將達到410億美元。
The Company has filed Cladribine ODF-related provisional patent applications with three to four patent applications expected to be on file in major international jurisdictions by late 2024 to early 2025 with potential patent protection extending to 2044.
該公司已提交與Cladribine ODF相關的臨時專利申請,並預計到2024年底至2025年初將在主要國際管轄區提交三至四項專利申請,有可能的專利保護期延長至2044年。
About BioNxt Solutions Inc.
關於BioNxt Solutions公司 BioNxt Solutions公司是一個生物科學加速器,專注於新型藥物配方和輸送系統,診斷篩查測試,以及新型活性藥物生產和評估,包括:精確皮膚透皮和口腔可溶性藥物配方;快速,低成本的傳染病和口腔健康篩查測試;以及新興活性藥物成分的標準化和臨床評估,用於神經系統應用。該公司在北美和歐洲進行研究和開發業務,其運營重點在德國,目前專注於爲歐洲市場獲得監管批准和商業化醫療產品。
BioNxt Solutions Inc. is a bioscience accelerator focused on next-generation drug formulations and delivery systems, diagnostic screening tests, and new active pharmaceutical production and evaluation, including: precision transdermal and oral dissolvable drug formulations; rapid, low-cost infectious disease and oral health screening tests; and standardization and clinical evaluation of emerging active pharmaceutical ingredients for neurological applications. The Company has research and development operations in North America and Europe, with an operational focus in Germany, and is currently focused on regulatory approval and commercialization of medical products for European markets.
BioNxt Solutions Inc.是專注於下一代藥物配方和傳遞系統,診斷篩查測試以及新型活性藥物生產和評估的生物科學加速器,包括:精密經皮和口服可溶性藥物配方;快速,低成本的傳染病和口腔健康篩查測試;以及用於神經學應用的新型活性藥物成分的標準化和臨床評估。該公司在北美和歐洲擁有研發業務,在德國有運營重點,目前專注於獲得歐洲市場的醫療產品的監管批准和商業化。
BioNxt Solutions Inc.
BioNxt Solutions Inc.
Wolfgang Probst, CEO and Director
Email: info@bionxt.com
Phone: +1 780-818-6422
董事兼首席執行官Wolfgang Probst
電子郵件:info@bionxt.com
電話:+1 780-818-6422
Cautionary Statement Regarding "Forward-Looking" Information
「前瞻性」信息的謹慎聲明
Some of the statements contained in this news release are forward-looking statements and information within the meaning of applicable securities laws. Forward-looking statements and information can be identified by the use of words such as "expects", "intends", "is expected", "potential", "suggests" or variations of such words or phrases, or statements that certain actions, events or results "may", "could", "should", "would", "might" or "will" be taken, occur or be achieved. Forward-looking statements and information are not historical facts and are subject to a number of risks and uncertainties beyond the Company's control. Actual results and developments are likely to differ, and may differ materially, from those expressed or implied by the forward-looking statements contained in this news release. Accordingly, readers should not place undue reliance on forward-looking statements. The Company undertakes no obligation to update publicly or otherwise revise any forward-looking statements, except as may be required by law.
本新聞稿中包含的一些聲明屬於前瞻性聲明和信息,屬於適用證券法律的意義範圍。前瞻性聲明和信息可以通過使用諸如「預計」,「打算」,「預計」,「潛在」,「建議」或此類詞或短語的變體,或者陳述某些行動,事件或結果「可能」,「可能」,「應該」,「將」,「可能」或「將」被採取,發生或實現。前瞻性聲明和信息不屬於歷史事實,且可能面臨公司無法控制的許多風險和不確定性。實際結果和發展可能會有所不同,且可能與本新聞稿中包含的前瞻性聲明所表達或暗示的結果或發展存在實質性差異。因此,讀者不應過分依賴前瞻性聲明。本公司無義務公開更新或以其他方式修正任何前瞻性聲明,除非法律要求。
SOURCE: BioNxt Solutions Inc.
資料來源:BioNxt Solutions公司
譯文內容由第三人軟體翻譯。