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Achiko's Rapid Covid-19 Diagnostic Test AptameX(TM) Receives Product and Registration Approval from Indonesia's Ministry of Health

Achiko's Rapid Covid-19 Diagnostic Test AptameX(TM) Receives Product and Registration Approval from Indonesia's Ministry of Health

Achiko的新冠肺炎快速診斷測試AptameX(TM)獲得印尼衞生部的產品和註冊批准
Accesswire ·  2021/08/25 01:12
  • AptameX TM , Achiko's breakthrough DNA aptamer-based diagnostic test for Covid-19, received product and registration emergency use approval from the Ministry of Health in Indonesia, alongside its sister digital passporting service, Teman Sehat TM ("Health Buddy").
  • PT Achiko Medika Indonesia, which is 50% owned by Achiko AG, and its manufacturing partner, PT Indofarma TBK, have signed an agreement for the production and registration of AptameX TM .
  • The approval, together with the partnership with PT Indofarma TBK, will enable access to low-cost and accurate Covid-19 testing for over 270 million Indonesians.
  • Achiko closes funding with strategic investors for CHF 3.45 million. Proceeds will be used for working capital, business consolidation, and redemption of the Yorkville convertible note facility.
  • AptameXTM,Achiko為新冠肺炎提供的突破性dna適配子診斷測試,與其姊妹數字護照服務Teman Sehat一起,獲得了印度尼西亞衞生部的產品和註冊緊急使用批准TM(“健康夥伴”)。
  • Achiko AG擁有50%股份的PT Achiko Medika印度尼西亞公司與其製造合作伙伴PT Indofarma TBK簽署了一項生產和註冊AptameX的協議TM .
  • 這一批准,再加上與PT Indofarma TBK的合作伙伴關係,將使2.7億多印尼人能夠獲得低成本和準確的新冠肺炎測試。
  • Achiko以345萬瑞士法郎完成了與戰略投資者的融資。所得資金將用於營運資金、業務整合和贖回約克維爾可轉換票據融資。

ZURICH, SWITZERLAND / ACCESSWIRE / August 25, 2021 / Ad hoc announcement pursuant to Art. 53 LR - Achiko AG (SWX: ACHI, ISIN CH0522213468) through PT Achiko Medika Indonesia ("Achiko", the "Company"), is pleased to announce that the Ministry of Health of the Republic of Indonesia has granted product and registration approval for its proprietary low-cost, rapid Covid-19 diagnostic test, AptameX TM , alongside its sister digital passporting service, Teman Sehat TM ("Health Buddy"). Achiko's 50%-subsidiary, PT Achiko Medika Indonesia, and PT Indofarma TBK ("Indofarma) have entered into an agreement to manufacture AptameX TM and have received product registration approval in Indonesia.

瑞士蘇黎世/ACCESSWIRE/2021年8月25日/根據第53條LR特別公告-Achiko AG(SWX:ACHI,ISIN CH0522213468)通過PT Achiko Medika印度尼西亞公司(“Achiko”,“公司”)高興地宣佈,印度尼西亞共和國衞生部已批准其專有的低成本快速新冠肺炎診斷測試AptameX的產品和註冊。TM,以及其姊妹數字護照服務Teman SehatTM(“健康夥伴”)。Achiko持股50%的子公司PT Achiko Medika印度尼西亞公司和PT Indofarma TBK公司(簡稱Indofarma公司)達成了製造AptameX的協議TM並已在印尼獲得產品註冊批准。

The approval opens the door to the rapid scale-up of production and sale of Achiko's AptameX TM test kits in Indonesia. Available at an affordable price, AptameX TM provides millions of Indonesian residents with access to accurate diagnostic testing for Covid-19, enabling the country to more effectively control and contain the pandemic. Indonesia passed 50,000 daily Covid-19 cases in mid-July, amid the spread of the Delta variant in Southeast Asia.

這一批准為迅速擴大Achiko的AptameX的生產和銷售打開了大門TM印尼的試劑盒。以實惠的價格提供AptameXTM為數以百萬計的印尼居民提供新冠肺炎的準確診斷檢測,使該國能夠更有效地控制和遏制疫情。隨着達美病毒在東南亞的傳播,印尼在7月中旬每天超過50,000例新冠肺炎病例。

"We are proud and excited to receive the official approval for our breakthrough test kit AptameX TM . It is an immense achievement for us to be able to market it with Indofarma," said Steven Goh, CEO of Achiko. "At the projected vaccination rate, and considering likely mutations of the virus, the next few years may be very challenging not only for Indonesia, but also quite possibly for the entire world. The combination of AptameX TM and Teman Sehat TM provides communities and governments with an affordable, easy-to-use test and a digital passporting service, empowering them in their fight against Covid-19 and all its variants."

我們為我們突破性的測試套件AptameX獲得官方批准感到自豪和興奮TM。Achiko公司的首席執行官Steven Goh説:“對我們來説,能夠用Indofarma銷售它是一項巨大的成就,按照預計的疫苗接種率,考慮到病毒可能的變異,未來幾年不僅對印度尼西亞,而且很可能對整個世界都是非常具有挑戰性的。AptameX的組合TM和提曼·沙哈特TM為社區和政府提供負擔得起、易於使用的測試和數字護照服務,使他們能夠與新冠肺炎及其所有變種作鬥爭。“

Covid-19 poses a challenge to traditional testing methods, as low viral loads evade most rapid tests, calling for a new paradigm. AptameX TM uses a proprietary, novel chemistry matching the speed of lateral flow rapid tests, while improving on sensitivity. At a significantly lower price point than other tests, it also offers a better user experience. Those that test positive are alerted promptly through the Teman Sehat TM digital passporting service and asked to follow local guidelines on isolation and quarantine. Its affordability, scalability and superior performance make it an ideal tool in Indonesia's fight against Covid-19.

新冠肺炎對傳統檢測方法提出了挑戰,因為低病毒載量避開了最快速的檢測,需要一種新的範式。AptameXTM採用專有的、新穎的化學物質,與橫向流動快速測試的速度相匹配,同時提高了靈敏度。它的價格比其他測試低得多,也提供了更好的用户體驗。那些檢測呈陽性的人會通過Teman Sehat迅速發出警報TM數字護照服務,並要求遵守當地關於隔離和檢疫的指導方針。它的可負擔性、可擴展性和卓越的性能使其成為印尼對抗新冠肺炎的理想工具。

Indofarma's President Director, Arief Pramuhanto, explains: "Testing regularly is crucial in containing the pandemic. AptameX TM is a Covid-19 diagnostic test produced domestically by and for the people of Indonesia that has been designed to be integrated into dental hygiene routines. Access to reliable and affordable testing will allow us to lead normal lives again and at the same time work to control the spread of Covid-19. Indofarma, in partnership with Achiko, aims to make this diagnostic readily available at an affordable price for everyone."

印度支那的總裁阿里夫·普拉穆漢託(Arief Pramuhanto)解釋説:“定期檢測對於控制疫情至關重要。AptameXTM這是一種由印度尼西亞人自制併為印尼人民生產的新冠肺炎診斷測試,旨在融入牙齒衞生常規。獲得可靠和負擔得起的檢測將使我們重新過上正常的生活,同時努力控制新冠肺炎的傳播。Indofarma與Achiko合作的目標是讓每個人都能以負擔得起的價格隨時獲得這種診斷方法。“

Dr Morris S. Berrie, President of Achiko, added: "Our team has been tireless in developing our technologies for rapid, affordable, diagnostic testing for Covid-19 and other forthcoming indications. AptameX TM is designed to be easy to use and affordable, and therefore accessible to anyone. We believe AptameX TM and our digital passporting service Teman Sehat TM will be vital diagnostic resources for many years to come."

Achiko公司總裁莫里斯·S·貝里博士補充説:“我們的團隊一直在不知疲倦地開發我們的技術,為新冠肺炎和其他即將到來的適應症進行快速、負擔得起的診斷測試。TM設計簡單易用,價格實惠,因此任何人都可以使用。我們相信AptameXTM我們的數字護照服務Teman SehatTM將是未來許多年至關重要的診斷資源。“

In the cooperation between Achiko and Indofarma, a member of Indonesia's Holding BUMN Farmasi, which is partly owned by the Government of the Republic of Indonesia and listed on the Indonesia Stock Exchange (IDX: INAF), Achiko will provide the technology and all materials for diagnostic kits while Indofarma will carry out the production and product registration processes.

在Achiko和Indofarma之間的合作中,Achiko將提供診斷試劑盒的技術和所有材料,而Indofarma將執行生產和產品註冊程序。Indofarma是印度尼西亞控股公司BUMN Farmasi的成員之一,BUMN Farmasi由印度尼西亞共和國政府部分擁有,並在印尼證券交易所上市(IDX:INAF)。

Following the Ministry of Health's approval for AptameX TM , Achiko is looking forward to securing a CE mark and introducing AptameX TM and Teman Sehat TM swiftly in further countries and regions. In parallel, Achiko is also investigating applications of AptameX TM to a range of other pathogenic diseases and therapeutic indications.

在衞生部批准AptameX之後TM,Achiko期待着獲得CE標誌並推出AptameXTM和提曼·沙哈特TM迅速擴展到更多的國家和地區。與此同時,Achiko還在研究AptameX的應用TM一系列其他致病疾病和治療適應症。

Achiko, on product approval, has raised a total amount of CHF 3.45 million through share placement at an average price of CHF 0.192 per share to a leading Swiss venture capital group, OCS International Commodities & Investments FZCO and other private investors. The funds are to be used as working capital and production funds as well as for the redemption of the Yorkville convertible note facility from 25 November 2020.

產品批准後,Achiko以平均每股0.192瑞士法郎的價格向領先的瑞士風險投資集團OCS International Commodity&Investments FZCO和其他私人投資者配售股票,總共籌集了345萬瑞士法郎。這些資金將用作營運資金和生產資金,以及從2020年11月25日起贖回約克維爾可轉換票據基金。

"We're grateful for the support of all our investors and shareholders," said Achiko CEO Goh. "These most recent investments provide a solid platform to consolidate our strategy as a global leading diagnostics company, connecting our capabilities in Europe and Asia in the fight against the challenge of Covid-19."

“我們感謝所有投資者和股東的支持,”Achiko首席執行官Goh説。這些最新投資為鞏固我們作為全球領先診斷公司的戰略提供了一個堅實的平台,將我們在歐洲和亞洲對抗新冠肺炎挑戰的能力連接起來。“

ABOUT ACHIKO AG 
Achiko creates and develops new innovations in healthcare technology through its biotechnology division, AptameX TM , and its sister digital mobile health technology division, Teman Sehat TM . The Company has created a unique healthtech capability that provides user-friendly diagnostic testing integrated with a digital passport solution for the management of Covid-19.

關於ACHIKO AG Achiko通過其生物技術部門AptameX創造和開發醫療保健技術的新創新TM,以及其姊妹數字移動醫療技術部門Teman SehatTM。該公司創造了一項獨特的醫療技術能力,提供用户友好的診斷測試,並將其與數字護照解決方案集成在一起,用於新冠肺炎的管理。

AptameX TM comprises of DNA aptamer-based technology that is cost-effective, chemically synthesised and widely applicable to the evolving diagnostic field of healthcare. Together with the digital mobile health app Teman Sehat TM , Achiko is developing potential technologies that seek to deliver rapid, affordable diagnostic testing for a range of pathogenic diseases and therapeutic indications. The AptameX TM technology is licensed from Regenacellx.sl and Achiko has exclusive commercialisation rights.

AptameXTM由基於DNA適體的技術組成,這種技術具有成本效益,是化學合成的,廣泛應用於不斷髮展的醫療診斷領域。與數字移動健康應用Teman Sehat一起TM,Achiko正在開發潛在的技術,尋求為一系列致病疾病和治療適應症提供快速、負擔得起的診斷測試。AptameXTM這項技術是從Regacellx.sl公司獲得許可的,Achiko公司擁有獨家商業化權利。

Headquartered in Zurich, Achiko has offices in Hong Kong, Jakarta, Seoul and Singapore.

Achiko總部設在蘇黎世,在香港、雅加達、首爾和新加坡設有辦事處。

Further information can be found at www.achiko.com .

欲瞭解更多信息,請訪問www.achiko.com。

ABOUT PT ACHIKO MEDIKA INDONESIA 
Achiko AG and PT Indonesia Farma Medis ("IFM") have established the joint venture company PT Achiko Medika Indonesia ("AMI") for the production and marketing of its testing platform developed from AptameX TM , a non-invasive DNA aptamer technology for the detection of Covid-19, for Indonesia. Its partner, IFM, is a medical device and pharmaceutical distribution company with a large network of relationships and distribution channels that includes hospitals, pharmacies and clinics across the main islands of Indonesia.

關於PT ACHIKO Medika印度尼西亞 Achiko AG和PT印度尼西亞Farma Medis(“IFM”)成立了合資公司PT Achiko Medika印度尼西亞(“AMI”),用於生產和銷售由AptameX開發的測試平台TM,一種用於檢測新冠肺炎的非侵入性DNA適配子技術,為印度尼西亞提供。它的合作伙伴IFM是一家醫療器械和藥品分銷公司,擁有龐大的關係和分銷渠道網絡,包括印尼主要島嶼的醫院、藥店和診所。

Further information can be found at https://achikomedika.com .

欲瞭解更多信息,請訪問https://achikomedika.com。

ABOUT PT INDOFARMA TBK 
PT Indofarma TBK is one of Indonesia's oldest pharmaceutical companies that was founded in 1918 and in January 2020 became part of the BUMN Farmasi Holding.

關於PT INDOFARMA TBK PT Indofarma TBK是印尼歷史最悠久的製藥公司之一,成立於1918年,並於2020年1月成為BUMN Farmasi控股公司的一部分。

PT Indofarma TBK continues to support the Government of the Republic of Indonesia programs in the health sector and contribute to improving health status and a better quality of life by committing to provide medicines with guaranteed quality and affordable prices for the community. In addition, the Company also supports the efforts of the government of the Republic of Indonesia in accelerating the handling of the Covid-19 pandemic by providing pharmaceutical products and medical devices, as well as health services. To date, Indofarma has had 321 distribution licenses for medicinal products and medical devices with distribution coverage spread across 29 branches throughout Indonesia.

PT Indofarma TBK繼續支持印度尼西亞共和國政府在衞生部門的計劃,並通過承諾為社區提供質量保證和價格合理的藥品,為改善健康狀況和改善生活質量做出貢獻。此外,該公司還通過提供藥品和醫療器械以及衞生服務,支持印度尼西亞共和國政府加快應對新冠肺炎疫情的努力。到目前為止,Indofarma已經擁有321個醫療產品和醫療器械的分銷許可證,分銷覆蓋整個印度尼西亞的29個分支機構。

Further information can be found at https://indofarma.id .

欲瞭解更多信息,請訪問https://indofarma.id。

Media contacts:

媒體聯繫人:

ACHIKO AG 
Investor Relations 
E: ir@achiko.com

阿奇科股份公司 投資者關係電子郵箱:ir@achiko.com

Switzerland & Global 
Marcus Balogh
Farner Consulting Ltd.
E: achiko@farner.ch 
T: +41 44 266 67 67

瑞士與全球 馬庫斯·巴洛赫法納諮詢有限公司電子郵箱:achiko@farner.chT: +41 44 266 67 67

Disclaimer 
This communication expressly or implicitly contains certain forward-looking statements concerning Achiko AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Achiko AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Achiko AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

免責 本通訊明示或暗示包含有關Achiko AG及其業務的某些前瞻性陳述。此類表述涉及某些已知和未知的風險、不確定性和其他因素,可能導致Achiko AG的實際結果、財務狀況、業績或成就與此類前瞻性表述中明示或暗示的任何未來結果、業績或成就大不相同。截至目前,Achiko AG正在提供這一信息,不承諾因新信息、未來事件或其他原因而更新本文中包含的任何前瞻性陳述。

SOURCE: Achiko AG

資料來源:阿奇科股份公司


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