share_log

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

BioNxt与Gen-Plus GmbH & Co KG签署意向书,以便进行可能的业务合作
Accesswire ·  08/15 03:05

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)很高兴宣布已与总部位于德国的国际合同研究、开发和制造公司Gen-Plus GmbH & Co KG(“Gen-Plus”), Conscio集团的一部分,签署了一份非约束性意向书(“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.

根据BioNxt和Gen-Plus于2024年7月9日和7月17日分别签署的主服务协议和Cladribine工作声明,LOI认可了双方在多个重要领域开展潜在合作的可能性,包括但不限于新药物产品的知识产权和原型开发、临床试验规划和批量制造、实验室、设备和办公室合作、业务拓展以及薄膜商业制造。公司将在合作计划具体进展后提供进一步的详细信息。

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.

总部位于德国慕尼黑的Conscio Group旗下的Gen-Plus在全球范围内有五个国家的设施和超过500名员工,为GCP/GLP/GMP/ISO/IEC认证的服务和药物制造提供认证,包括临床试验用药品的GMP认证(第I-III阶段),专注于固体、半固体、液体、口服薄膜、透皮贴片及GMP制造期间的综合实验室分析服务,包括API表征、方法开发、优化、验证、过渗性研究、稳定性研究等

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正在开发100%自有和专有的ODF Cladribine剂量形式,用于多发性硬化("MS")市场。Cladribine片目前已获得超过75个国家的批准,包括美国食品和药品管理局("FDA")和欧洲药品管理局("EMA"),年销售额超过10亿美元。Cladribine片获批几种适应症,即高度活动的复发缓解型MS和某些形式的白血病。多发性硬化是Cladribine销售的最大市场细分,全球大约有230万人患有MS,在北美和欧洲的患病率最高,据MS地图所述。根据Market.us,全球多发性硬化药物市场预计到2033年将达到410亿美元。

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.

该公司已提交与Cladribine ODF相关的临时专利申请,并预计到2024年底至2025年初将在主要国际管辖区提交三至四项专利申请,有可能的专利保护期延长至2044年。

About BioNxt Solutions Inc.

关于BioNxt Solutions公司 BioNxt Solutions公司是一个生物科学加速器,专注于新型药物配方和输送系统,诊断筛查测试,以及新型活性药物生产和评估,包括:精确皮肤透皮和口腔可溶性药物配方;快速,低成本的传染病和口腔健康筛查测试;以及新兴活性药物成分的标准化和临床评估,用于神经系统应用。该公司在北美和欧洲进行研究和开发业务,其运营重点在德国,目前专注于为欧洲市场获得监管批准和商业化医疗产品。

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.是专注于下一代药物配方和传递系统,诊断筛查测试以及新型活性药物生产和评估的生物科学加速器,包括:精密经皮和口服可溶性药物配方;快速,低成本的传染病和口腔健康筛查测试;以及用于神经学应用的新型活性药物成分的标准化和临床评估。该公司在北美和欧洲拥有研发业务,在德国有运营重点,目前专注于获得欧洲市场的医疗产品的监管批准和商业化。

BioNxt Solutions Inc.

BioNxt Solutions Inc.

Wolfgang Probst, CEO and Director
Email: info@bionxt.com
Phone: +1 780-818-6422

董事兼首席执行官Wolfgang Probst
电子邮件:info@bionxt.com
电话:+1 780-818-6422

Cautionary Statement Regarding "Forward-Looking" Information

“前瞻性”信息的谨慎声明

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.

本新闻稿中包含的一些声明属于前瞻性声明和信息,属于适用证券法律的意义范围。前瞻性声明和信息可以通过使用诸如“预计”,“打算”,“预计”,“潜在”,“建议”或此类词或短语的变体,或者陈述某些行动,事件或结果“可能”,“可能”,“应该”,“将”,“可能”或“将”被采取,发生或实现。前瞻性声明和信息不属于历史事实,且可能面临公司无法控制的许多风险和不确定性。实际结果和发展可能会有所不同,且可能与本新闻稿中包含的前瞻性声明所表达或暗示的结果或发展存在实质性差异。因此,读者不应过分依赖前瞻性声明。本公司无义务公开更新或以其他方式修正任何前瞻性声明,除非法律要求。

SOURCE: BioNxt Solutions Inc.

资料来源:BioNxt Solutions公司


声明:本内容仅用作提供资讯及教育之目的,不构成对任何特定投资或投资策略的推荐或认可。 更多信息
    抢沙发