VANCOUVER, BC / ACCESSWIRE / March 13, 2024 / BioNxt Solutions Inc. ('BioNxt' or the 'Company') (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT) is pleased to report that the comparative pharmacokinetic ('PK') study for its oral dissolvable film ('ODF') based proprietary Cladribine product for the treatment of Multiple Sclerosis ('MS') has been completed and results received by the Company.

不列颠哥伦比亚省温哥华/ACCESSWIRE/2024年3月13日/BioNxt Solutions Inc.（“BioNxt”或“公司”）（CSE:BNXT）（OTCQB:BNXTF）（FSE:BXT）很高兴地报告，其用于治疗多发性硬化症（“MS”）的口服可溶性薄膜（“ODF”）专利克拉屈滨产品的比较药代动力学（“PK”）研究已经完成，公司收到了结果。

The animal PK study results are highly promising and demonstrated comparable rapid absorption and systemic exposure between the Company's ODF product and the name-brand reference drug in all samples..

动物PK研究结果非常有希望，并证明该公司的ODF产品与所有样品中的名牌参考药物之间具有可比的快速吸收和全身暴露。。

'These results are a significant milestone for BioNxt. We have demonstrated that our ODF platform is an effective drug delivery system for cytostatic drugs via transmucosal absorption,' said Hugh Rogers, CEO of BioNxt. 'With our recently obtained toxicology data, the PK results allow us to strengthen the Company's Cladribine ODF patent position and proceed immediately to a PK study in humans.

“这些结果是BioNxt的一个重要里程碑。BioNxt首席执行官休·罗杰斯（HughRogers）说：“我们已经证明，我们的ODF平台是一种有效的药物输送系统，可以通过跨粘膜吸收来抑制细胞生长。”根据我们最近获得的毒理学数据，PK结果使我们能够加强该公司的克拉屈滨ODF专利地位，并立即进行人体PK研究。

These exciting results validate the potential for BioNxt to immediately expand into additional ODF drug formulations for similar, high-value and highly toxic drugs.'.

这些令人兴奋的结果验证了BioNxt立即扩展到类似，高价值和高毒性药物的其他ODF药物制剂的潜力。”。

BioNxt is developing a 100% owned and proprietary hybrid-generic ODF Cladribine dosage form, directed at the 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.

BioNxt正在开发一种100%拥有和专有的混合通用ODF克拉屈滨剂型，针对MS市场。克拉屈滨片剂目前已被批准在75多个国家使用，包括美国食品和药物管理局（FDA）和欧洲药品管理局（EMA），年销售额超过10亿美元。

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.

克拉屈滨片被批准用于多种适应症，即高活性形式的复发缓解型MS和某些形式的白血病。MS是克拉屈滨销售的最大细分市场，全球约有230万人患有MS，MS图谱指出，MS在北美和欧洲的患病率最高。

The global Multiple Sclerosis drug market is expected to top USD 41 billion by 2033 according to Market.us..

据市场预测，到2033年，全球多发性硬化症药物市场预计将超过410亿美元。。

The comparative PK study was carried out by a European contract research organization in accordance with EU medical regulatory guidelines using animal models and a single administration of either sublingual (ODF) or oral (tablet) Cladribine. Blood testing and analysis was carried out pre-dose and at up to six time points after administration using blood aliquots.

比较PK研究由欧洲合同研究组织根据欧盟医学监管指南进行，使用动物模型和单次服用舌下（ODF）或口服（片剂）克拉屈滨。在给药前和给药后多达六个时间点使用血液等分试样进行血液测试和分析。

The animal PK study results closely follows the unanimously successful results of the ODF Cladribine animal toxicity study, announced February 7, 2024: positive results were observed in all study participants with no adverse clinical abnormalities or indications of toxicity observed in the study after consecutive days of dosing..

动物PK研究结果与2024年2月7日宣布的ODF克拉屈滨动物毒性研究一致成功的结果密切相关：所有研究参与者均观察到阳性结果，连续给药几天后，研究中未观察到不良临床异常或毒性迹象。。

BioNxt has accelerated its Cladribine ODF program in a priority manner with GMP product development and batch production planned for Q1 and Q2 2024 with the European Investigational Medicinal Product Dossier (IMPD) preparation and submission planned for Q2 2024.

BioNxt已优先加速其克拉屈滨ODF计划，计划于2024年第1季度和第2季度进行GMP产品开发和批量生产，并计划于2024年第2季度编制和提交欧洲研究药品档案（IMPD）。

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.

该公司已经提交了克拉屈滨ODF相关的临时专利申请，预计到2024年底至2025年初，将在主要国际司法管辖区提交三到四项专利申请，潜在的专利保护将延长至2044年。

BioNxt's wholly owned subsidiary is a German narcotics manufacturer, developer, and researcher located in the district of Biberach, Baden-Württemberg, Germany. For over a decade, the company and its team have been leaders in the design, testing and manufacture of innovative, non-invasive drug delivery systems, particularly transdermal patches and sublingual strips for the delivery of active pharmaceutical ingredients for the treatment of pain and neurological conditions.

BioNxt的全资子公司是一家德国麻醉品制造商、开发商和研究人员，位于德国巴登-符腾堡Biberach区。十多年来，该公司及其团队在设计、测试和制造创新的非侵入性药物输送系统方面一直处于领先地位，特别是透皮贴剂和舌下贴片，用于输送治疗疼痛和神经系统疾病的活性药物成分。

According to Precedence Research, the global pharmaceutical drug delivery market size was valued at USD 1,525 billion in 2022 and expected to surpass approximately USD 2,047 billion by 2030..

根据Preference Research的数据，2022年全球药物输送市场规模为15250亿美元，预计到2030年将超过约20470亿美元。。

About BioNxt Solutions Inc.

关于BioNxt Solutions Inc。

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.

BioNxt Solutions Inc.是一家生物科学加速器，专注于下一代药物制剂和递送系统，诊断筛选测试以及新的活性药物生产和评估，包括：精密透皮和口服可溶性药物制剂；快速，低成本的传染病和口腔健康筛查测试；以及用于神经系统应用的新兴活性药物成分的标准化和临床评估。

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..

该公司在北美和欧洲拥有研发业务，运营重点在德国，目前专注于欧洲市场医疗产品的监管审批和商业化。。

BioNxt Solutions Inc.

BioNxt解决方案公司。

Hugh Rogers, CEO and Director

首席执行官兼董事休·罗杰斯

Email: info@bionxt.com

电子邮件info@bionxt.com

Phone: +1 780-818-6422

电话：+1 780-818-6422

Cautionary Statement Regarding 'Forward-Looking' Information

关于“前瞻性”信息的警示声明

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.

本新闻稿中的一些声明是适用证券法意义上的前瞻性声明和信息。前瞻性陈述和信息可以通过使用诸如“期望”、“打算”、“预期”、“潜在”、“建议”或此类词语或短语的变体，或某些行动、事件或结果“可能”、“可能”、“应该”、“将会”、“可能”或“将要”采取、发生或实现的陈述来识别。

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.

前瞻性陈述和信息不是历史事实，并且受到公司无法控制的许多风险和不确定性的影响。实际结果和发展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和发展有所不同，也可能存在重大差异。

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..

因此，读者不应过度依赖前瞻性陈述。除非法律可能要求，否则公司没有义务公开更新或以其他方式修改任何前瞻性声明。。

SOURCE: BioNxt Solutions Inc.

来源：BioNxt Solutions Inc。

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