- NMPA grants Syntellix product approval for the world’s most important future market with more than 1.4 billion people
- Syntellix’ product approval for China is the largest and most important success in the company’s history; product approval in China was the company’s most important strategic and operational goal
- Syntellix had previously already been granted the accelerated ‘innovative pathway’ by the NMPA due to the exceptional benefits of its products
- In total, product approvals for Syntellix products have accumulated to date in countries with more than 5.5 billion inhabitants; product approvals had already been achieved in 73 countries and regions on five continents before current success in China
- Development of the prioritized core markets of China, India, and ASEAN is being carried out via Syntellix Asia Pte Ltd in Singapore as manufacturing facility & sales hub
- Syntellix Asia Pte Ltd has been supported by the Singapore Economic Development Board (EDB); Syntellix AG targets IPO on the Singapore Exchange (SGX)
- Syntellix and Syntellix Asia CEO Claassen: “After 7 years of focusing on China, we have achieved what almost everyone considered impossible. As a startup with its operational heart in Singapore, we have written a pioneering story worldwide, whose global medical success can now no longer be stopped. I sincerely thank the Singapore Economic Development Board (EDB) for its far-sighted contribution to the operational and structural foundation of our rollout in Asia by providing expertise and financial support for the establishment and expansion of our production facility in Singapore, which will now also become an Asia-wide and global sales hub as planned.”
Syntellix AG, parent company of Singapore-based, Syntellix Asia Pte Ltd, has received product approval for the People’s Republic of China from the Chinese NMPA (National Medical Products Administration) in Beijing, which is responsible for the government regulation, registration, and monitoring of medical devices for the Chinese market. This product approval for the world’s most important future market, with more than 1.4 billion people, is by far the greatest and most important success in the company’s history. Syntellix AG had declared the development of the vast Chinese market its top strategic priority following Professor Dr Utz Claassen’s assumption of office as CEO of the company. After Syntellix had already previously been granted the accelerated ‘innovative pathway’ by the NMPA due to the particular advantages of its products, the initial approval process has now been completed extremely successfully. It was the most complex, intensive, and sophisticated approval process Syntellix has ever undergone in terms of product safety and quality management systems.
Syntellix now has obtained product approvals in countries with more than 5.5 billion inhabitants, or more than two thirds of the world’s population. Syntellix had previously received product approvals in 73 countries and regions on five continents, including all of Europe, Australia and New Zealand, South Africa, Singapore, Israel, and Saudi Arabia, as well as fast-growing, demographically dynamic countries such as Indonesia, Vietnam, the Philippines, and Thailand, as well as the world’s most populous country – India. China and India, with a combined population of almost 3 billion, open up entirely new dimensions of potential for the company in many respects. Syntellix’ highly innovative bioabsorbable metallic implants are produced by Syntellix Asia Pte Ltd which is based in JTC’s Tuas Biomedical Park. The Economic Development Board (EDB) had provided initial grants to Syntellix to support the establishment of its manufacturing presence and global sales hub in Singapore.
With the product approval now achieved in China, labelled by German news platform ‘Pressefeuer’ a ‘strategic triumph’ that could revolutionize the world of biomedical engineering and is a decisive step for the Hanover-based company’, Syntellix has achieved its most important strategic and operational goal. The strategic decision to develop the prioritized core markets of China, India, and ASEAN through Syntellix Asia Pte Ltd in Singapore, and to locate and expand the main production site in the ultra-modern and highly efficient island nation of Singapore, has proven to be both expedient and entirely correct. Establishing an Asia-centric production chain was strategically and operationally the right decision, as the production and sales hub in Singapore can supply and serve most of the world better and faster than from Germany or Europe. More than 3.5 billion people live in China, India, and the ASEAN region alone, which is more than 40 times the population of the Federal Republic of Germany, while at the same time experiencing significantly greater dynamics in terms of population growth, market growth, and economic power and perspectives.
For this purpose – establishing and expanding production in Singapore, tapping into the South Asian, Southeast Asian, and East Asian markets, and obtaining the necessary product approvals, particularly in China, – Syntellix, CEO Professor, Dr Utz Claassen, who is also Executive Chairman & CEO of Syntellix Asia Pte Ltd in Singapore, relocated his residence from Germany to Singapore more than five years ago in consultation and coordination with the Supervisory Board of Syntellix AG.
Syntellix CEO Professor Utz Claassen thus commented very positively on the product approval now achieved in China: “After more than 17 years of work and more than 7 years of focusing on China alone, we have achieved what almost everyone considered impossible. As a startup from Hanover with ist operational heart in Singapore, we have written a pioneering story worldwide, whose global medical success is now unstoppable. Those who win in China are strategically and operationally ideally positioned. The largest hospitals in China individually have higher patient volumes and more operations for our highly innovative products than most countries in the European Union. Without neglecting our homeland, we are proud and grateful to now be able to use our products, which are so beneficial for patients, users, and the healthcare system, in China, with its 5,000 years of cultural history, its magnificent medical tradition, and its unique future prospects. This is a game changer for our company, both qualitatively and quantitatively.”
Claassen emphasizes both the abstract and concrete positive conditions for the successful development of Syntellix’ activities in Asia, and also specifically in Singapore, and he is grateful for the very positive environment here: “I would like to expressly thank our outstanding Chinese partners for their tremendous support and cooperation, and the NMPA for an outstandingly differentiated and structured approval process. I would also like to sincerely thank the Singapore Economic Development Board (EDB) for its far-sighted contribution to the operational and structural foundation of our rollout in Asia by providing expertise and financial support for the establishment and expansion of our production facility in Singapore, which will now also become an Asia-wide and global sales hub as planned. This will create many attractive jobs in Singapore and set new international standards in biomedical engineering under market conditions that are not found in Germany or Europe, and building on government funding from the Republic of Singapore.”
Syntellix AG, as a joint-stock company under German stockholding law already a public company, also targets an IPO on the Singapore Exchange (SGX), the preparations of which have already been ongoing for several years with the help of Singaporean banks and law firms, well supported by SGX management under the leadership of its CEO Mr Loh Boon Chye and coordinated by Ms Alice Gwee.
