share_log

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宣佈與瑞士製藥有限公司就其候選VELDONA產品的藥物測試、製造和包裝達成主服務協議
Accesswire ·  2022/08/17 08:05

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

加利福尼亞州聖迭戈/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”)是一家多元化的醫療科技公司,專注於開發新型的護理點檢測、低劑量幹擾素療法和合成RNA驅動的預防性藥物。該公司今天宣佈,它已與瑞士製藥有限公司(臺灣)(“Swiss Pharma”)簽署了一項主服務協議。根據這項協議,瑞士製藥公司將測試、製造和包裝該公司的VELDONA“GMP臨牀批次”和“GMP商業批次”產品,以根據藥品檢驗合作計劃的良好製造規範(“PIC/S GMP”)和美國食品和藥物管理局(FDA)現行的良好製造規範進行公司計劃的臨牀試驗。

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.

該公司計劃在今年年底前向美國FDA提交第二階段研究的研究新藥(IND)申請。

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.

根據先前於2022年6月針對新冠肺炎進行的VELDONA配方的臨牀前研究結果,AINOS在臺灣啟動了“一項多中心、隨機、平行的第二階段研究,以評估VELDONA®對輕度新冠肺炎患者的療效”。

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.

該公司之前對其基於幹擾素的藥物平臺VELDONA的研究重點是各種病毒感染。該公司此前曾進行過前景看好的流感臨牀研究()和普通感冒(該公司計劃進一步推進其VELDONA計劃,於2023年啟動針對血小板減少症的第2階段研究和針對Sjögren綜合徵的第3階段研究。

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董事長兼首席執行官蔡俊賢表示:“我們與瑞士製藥公司的關係為我們開發VELDONA候選產品的計劃奠定了堅實的基礎。我們預計,我們與瑞士製藥公司的關係將使我們能夠有效地提高我們為VELDONA進行臨牀試驗的製造能力,包括測試、質量檢驗、標籤和包裝。”

About Ainos, Inc.

關於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.總部設在加利福尼亞州聖地亞哥,是一家多元化的醫療科技公司,致力於開發創新的醫療技術,用於護理點檢測和針對各種疾病適應症的安全和新穎的醫療治療。除了使用低劑量非注射幹擾素的專利療法外,Ainos還致力於開發涵蓋醫療設備和消費者保健產品的全面醫療保健業務組合。在將醫療器械商業化作為其多元化戰略的一部分作為優先事項的同時,Ainos還擴大了其產品組合,包括揮發性有機化合物(VOC)和新冠肺炎POCT。利用其與VOC技術和新冠肺炎POCT產品相關的專利,該公司尋求加快其醫療器械生產線的商業化進程,首先是Ainos品牌的新冠肺炎POCT候選產品。

About Swiss Pharmaceutical Co., Ltd (Taiwan)

關於瑞士製藥有限公司(臺灣)

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.

瑞士製藥公司成立於20世紀50年代,以開發和製造高質量的醫藥產品為使命,致力於不斷改進和進步。瑞士醫藥公司總部設在臺灣臺南市,現有員工400多人,年收入3000萬美元。其設施已通過臺灣食品藥品監督管理局的PIC/S GMP認證,並經過美國食品藥品監督管理局的檢查。

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.

在整個歷史中,瑞士製藥一直在創新產品,涵蓋了廣泛的治療領域和劑型,並繼續投入大量資源開發新產品和擴大製造能力。

Forward-Looking Statements

前瞻性陳述

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.

本新聞稿包含符合1995年美國私人證券訴訟改革法安全港條款的“前瞻性陳述”。前瞻性陳述可以通過諸如“預期”、“相信”、“估計”、“預期”、“打算”、“計劃”、“預測”、“項目”、“目標”、“未來”、“尋求”、“可能”、“戰略”、“可能”、“應該”、“將會”以及對未來時期的類似提法來識別。前瞻性陳述僅基於我們當前的信念、預期和假設。前瞻性陳述會受到固有的不確定性、風險和環境變化的影響,這些不確定性、風險和變化很難預測,其中許多是我們無法控制的。我們的實際結果可能與前瞻性陳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.

可能導致我們的實際結果與前瞻性陳述中顯示的結果大不相同的重要因素包括但不限於:本新聞稿中宣佈的計劃藥物治療的生產成本和銷售潛力;美國食品和藥物管理局(FDA)或其他監管機構對計劃藥物治療的最終批准的影響,包括緊急使用授權的可用性;公司有限的現金和歷史虧損;公司實現盈利的能力;公司行業的激烈競爭和快速進步的技術可能超過其技術;客户對公司開發的產品和服務的需求;競爭性或替代產品、技術和定價的影響;公司生產其開發的任何產品的能力;總體經濟狀況和事件及其可能對公司及其潛在客户造成的影響,包括但不限於“新冠肺炎”的影響;公司未來獲得充足資金的能力;世界衞生組織、食品和藥物管理局以及其他職能類似於食品和藥物管理局的政府機構頒佈和實施法規對公司業務和技術的影響;第三方的訴訟和其他索賠或管理公司運營的各種監管機構的調查;公司確保其產品獲得監管部門批准的能力;以及我們成功地管理上述項目中涉及的風險。讀者還應查閲我們截至2021年12月31日的Form 10-K年度報告以及我們提交給美國證券交易委員會的其他報告中列出的風險和不確定性。

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.

我們在本新聞稿中所作的任何前瞻性聲明僅限於該聲明發表之日。我們沒有義務公開更新任何可能不時作出的前瞻性陳述,無論是書面的還是口頭的,無論是新信息、未來發展還是其他情況。

Investor Relations Contact

投資者關係聯繫人

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

ICR,LLC
楊彥宏
電話:+1646-224-6971
電子郵件:Ainos.IR@icrinc.com

SOURCE: Ainos, Inc.

資料來源:Ainos公司


View source version on accesswire.com:


在accesswire.com上查看源代碼版本:

声明:本內容僅用作提供資訊及教育之目的,不構成對任何特定投資或投資策略的推薦或認可。 更多信息
    搶先評論