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Ainos Announces Master Services Agreement With Swiss Pharmaceutical, Ltd. for Drug Testing, Manufacturing, and Packaging for Its VELDONA Product Candidates

Ainos Announces Master Services Agreement With Swiss Pharmaceutical, Ltd. for Drug Testing, Manufacturing, and Packaging for Its VELDONA Product Candidates

Ainos宣布与瑞士制药有限公司就其候选VELDONA产品的药物测试、制造和包装达成主服务协议
Accesswire ·  2022/08/17 08:05

SAN DIEGO, CA / ACCESSWIRE / August 17, 2022 / 

加利福尼亚州圣迭戈/ACCESSWIRE/2022年8月17日/

$Ainos(AIMD.US)$/$AINOS INC C/WTS 29/07/2027 (TO PUR COM)(AIMDW.US)$ ("Ainos", or the "Company"), a diversified medtech company focused on the development of novel point-of-care testing, low-dose interferon therapeutics, and synthetic RNA-driven preventative medicine, today announced it has signed a Master Service Agreement with Swiss Pharmaceutical Co., Ltd. (Taiwan) ("Swiss Pharma"). Pursuant to the agreement, Swiss Pharma will test, manufacture, and package the Company's VELDONA "GMP Clinical Batch" and "GMP Commercial Batch" product candidates for the Company's planned clinical trials under both Pharmaceutical Inspection Co-operation Scheme Good Manufacturing Practice ("PIC/S GMP") and U.S. Food & Drug Administration ("U.S. FDA") Current Good Manufacturing Practice regulations.

$Ainos(AIMD.US)$/$Ainos Inc.C/WTS 29/07/2027(To Pur Com)(AIMDW.US)$(“Ainos”或“公司”)是一家多元化的医疗科技公司,专注于开发新型的护理点检测、低剂量干扰素疗法和合成RNA驱动的预防性药物。该公司今天宣布,它已与瑞士制药有限公司(台湾)(“Swiss Pharma”)签署了一项主服务协议。根据这项协议,瑞士制药公司将测试、制造和包装该公司的VELDONA“GMP临床批次”和“GMP商业批次”产品,以根据药品检验合作计划的良好制造规范(“PIC/S GMP”)和美国食品和药物管理局(FDA)现行的良好制造规范进行公司计划的临床试验。

The Company plans to submit an Investigational New Drug ("IND") application for a Phase 2 Study to the U.S. FDA by the end of this year.

该公司计划在今年年底前向美国FDA提交第二阶段研究的研究新药(IND)申请。

Following previous results from preclinical studies of its VELDONA formulation against COVID-19 in June 2022, Ainos initiated "A Multicenter, Randomized, Parallel, Phase II Study to Evaluate the Efficacy of VELDONA® in Patients with Mild COVID-19" in Taiwan.

根据先前于2022年6月针对新冠肺炎进行的VELDONA配方的临床前研究结果,AINOS在台湾启动了“一项多中心、随机、平行的第二阶段研究,以评估VELDONA®对轻度新冠肺炎患者的疗效”。

The Company's prior studies of its VELDONA, interferon-based drug platform, have focused on various viral infections. The Company has previously conducted promising clinical studies on influenza () and the common cold ( The Company plans to further its VELDONA program with the initiation of a Phase 2 study for thrombocytopenia and Phase 3 study for Sjögren's syndrome in 2023.

该公司之前对其基于干扰素的药物平台VELDONA的研究重点是各种病毒感染。该公司此前曾进行过前景看好的流感临床研究()和普通感冒(该公司计划进一步推进其VELDONA计划,于2023年启动针对血小板减少症的第2阶段研究和针对Sjögren综合征的第3阶段研究。

Chun-Hsien Tsai, Chairman and Chief Executive Officer of Ainos, commented, "Our relationship with Swiss Pharma forms a strong foundation for our plans to develop VELDONA product candidates. We anticipate our relationship with Swiss Pharma will enable us to effectively increase our manufacturing capabilities for VELDONA for our clinical trials, including testing, quality inspection, labeling, and packaging."

Ainos董事长兼首席执行官蔡俊贤表示:“我们与瑞士制药公司的关系为我们开发VELDONA候选产品的计划奠定了坚实的基础。我们预计,我们与瑞士制药公司的关系将使我们能够有效地提高我们为VELDONA进行临床试验的制造能力,包括测试、质量检验、标签和包装。”

About Ainos, Inc.

关于Ainos公司

Headquartered in San Diego, California, Ainos, Inc. is a diversified medtech company engaged in developing innovative medical technologies for point-of-care testing and safe and novel medical treatment for a broad range of disease indications. In addition to its proprietary therapeutics using low-dose non-injectable interferon, Ainos is committed to developing a comprehensive healthcare business portfolio encompassing medical devices and consumer healthcare products. While prioritizing the commercialization of medical devices as part of its diversification strategy, Ainos has also expanded its product portfolio to include Volatile Organic Compounds (VOC) and COVID-19 POCTs. Leveraging its patents related to VOC technologies and COVID-19 POCT products, the Company seeks to expedite the commercialization of its medical device pipeline, beginning with Ainos-branded COVID-19 POCT product candidates.

Ainos,Inc.总部设在加利福尼亚州圣地亚哥,是一家多元化的医疗科技公司,致力于开发创新的医疗技术,用于护理点检测和针对各种疾病适应症的安全和新颖的医疗治疗。除了使用低剂量非注射干扰素的专利疗法外,Ainos还致力于开发涵盖医疗设备和消费者保健产品的全面医疗保健业务组合。在将医疗器械商业化作为其多元化战略的一部分作为优先事项的同时,Ainos还扩大了其产品组合,包括挥发性有机化合物(VOC)和新冠肺炎POCT。利用其与VOC技术和新冠肺炎POCT产品相关的专利,该公司寻求加快其医疗器械生产线的商业化进程,首先是Ainos品牌的新冠肺炎POCT候选产品。

About Swiss Pharmaceutical Co., Ltd (Taiwan)

关于瑞士制药有限公司(台湾)

Swiss Pharma was established in the 1950s with a mission to develop and manufacture quality pharmaceutical products, and operates with a commitment to continuous improvement and advancement. Headquartered in Tainan City, Taiwan, Swiss Pharma currently has over 400 employees and annual revenue of US$30 million. Its facilities have been PIC/S GMP certified by the Taiwan Food and Drug Administration and inspected by the U.S. Food and Drug Administration.

瑞士制药公司成立于20世纪50年代,以开发和制造高质量的医药产品为使命,致力于不断改进和进步。瑞士医药公司总部设在台湾台南市,现有员工400多人,年收入3000万美元。其设施已通过台湾食品药品监督管理局的PIC/S GMP认证,并经过美国食品药品监督管理局的检查。

Throughout its history, Swiss Pharma has innovated products covering a wide range of therapeutic areas and dosage forms, and continues to invest a significant amount of resources in developing new products and expanding manufacturing capabilities.

在整个历史中,瑞士制药一直在创新产品,涵盖了广泛的治疗领域和剂型,并继续投入大量资源开发新产品和扩大制造能力。

Forward-Looking Statements

前瞻性陈述

This press release contains 'forward-looking statements' within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict," "project," 'target," "future," "seek," "likely," "strategy," "may," "should," "will," and similar references to future periods. Forward-looking statements are based only on our current beliefs, expectations, and assumptions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements.

本新闻稿包含符合1995年美国私人证券诉讼改革法安全港条款的“前瞻性陈述”。前瞻性陈述可以通过诸如“预期”、“相信”、“估计”、“预期”、“打算”、“计划”、“预测”、“项目”、“目标”、“未来”、“寻求”、“可能”、“战略”、“可能”、“应该”、“将会”以及对未来时期的类似提法来识别。前瞻性陈述仅基于我们当前的信念、预期和假设。前瞻性陈述会受到固有的不确定性、风险和环境变化的影响,这些不确定性、风险和变化很难预测,其中许多是我们无法控制的。我们的实际结果可能与前瞻性陈述中指出的大不相同。

Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others, the following: the cost of production and sales potential of the planned drug treatments announced in this press release; the impact of final approvals from the U.S. Food and Drug Administration (the "FDA") or other regulatory bodies for the planned drug treatments including the availability of emergency use authorization; the Company's limited cash and history of losses; the Company's ability to achieve profitability; intense competition and rapidly advancing technology in the Company's industry that may outpace its technology; customer demand for the products and services the Company develops; the impact of competitive or alternative products, technologies and pricing; the Company's ability to manufacture any products it develops; general economic conditions and events and the impact they may have on the Company and its potential customers, including but not limited to the impact of Covid-19; the Company's ability to obtain adequate financing in the future; the impact of promulgation and implementation of regulations by the World Health Organization, the FDA and by other governmental authorities with functions similar to those of the FDA on the Company's operations and technologies; lawsuits and other claims by third parties or investigations by various regulatory agencies governing the Company's operations; the Company's ability to secure regulatory approvals for its products; and our success in managing the risks involved in the foregoing items. Readers should also review the risks and uncertainties listed in our Annual Report on Form 10-K for the year ended December 31, 2021 and other reports we file with the U.S. Securities and Exchange Commission.

可能导致我们的实际结果与前瞻性陈述中显示的结果大不相同的重要因素包括但不限于:本新闻稿中宣布的计划药物治疗的生产成本和销售潜力;美国食品和药物管理局(FDA)或其他监管机构对计划药物治疗的最终批准的影响,包括紧急使用授权的可用性;公司有限的现金和历史亏损;公司实现盈利的能力;公司行业的激烈竞争和快速进步的技术可能超过其技术;客户对公司开发的产品和服务的需求;竞争性或替代产品、技术和定价的影响;公司生产其开发的任何产品的能力;总体经济状况和事件及其可能对公司及其潜在客户造成的影响,包括但不限于“新冠肺炎”的影响;公司未来获得充足资金的能力;世界卫生组织、食品和药物管理局以及其他职能类似于食品和药物管理局的政府机构颁布和实施法规对公司业务和技术的影响;第三方的诉讼和其他索赔或管理公司运营的各种监管机构的调查;公司确保其产品获得监管部门批准的能力;以及我们成功地管理上述项目中涉及的风险。读者还应查阅我们截至2021年12月31日的Form 10-K年度报告以及我们提交给美国证券交易委员会的其他报告中列出的风险和不确定性。

Any forward-looking statement made by us in this press release speaks only as of the date on which such statement is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

我们在本新闻稿中所作的任何前瞻性声明仅限于该声明发表之日。我们没有义务公开更新任何可能不时作出的前瞻性陈述,无论是书面的还是口头的,无论是新信息、未来发展还是其他情况。

Investor Relations Contact

投资者关系联系人

ICR, LLC
Robin Yang
Tel: +1 646-224-6971
Email: Ainos.IR@icrinc.com

ICR,LLC
杨彦宏
电话:+1646-224-6971
电子邮件:Ainos.IR@icrinc.com

SOURCE: Ainos, Inc.

资料来源:Ainos公司


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