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Company insight Clinical ambitions for APAC


Beginning life as a pharmacy serving the German city of Freiburg in the 1960s, founder Josef Kuenle, while a visionary and dedicated pharmacist, could not have imagined the international reach Komtur Pharmaceuticals Group would have a little over half a century later. Today, through 17 fully owned subsidiaries in 16 countries on four continents, the group is a leading supplier of therapeutics around the world – sourcing, storing and delivering products. General manager and regional director for APAC, Jan Oesterreich, talks of the path this journey is now carving across Asia.


What’s Komtur’s involvement in Asia? Jan Oesterreich: Compared to many others, we came to Asia very early. When we opened our operation in Shanghai in 2000, clinical trials were uncharted territory. These early days provided us with invaluable experience in the regulatory network and laid the foundation for supplier and client contacts. Today we have an unparalleled network of qualified suppliers across the region; including in Korea, Japan and Singapore.


What are the most crucial aspects when organising trial supplies in ‘difficult to navigate’ markets like APAC and China?


Unlike the situation in harmonised economic areas such as Europe or the NAFTA zone, clinical sourcing and distribution in APAC remains a disparate landscape of national markets. In many cases, supply projects struggle or stall because import documentation requirements have not been checked carefully, or the availability of comparator products is taken for granted. We're still seeing clients who, with all the best intentions, prepare import documentations based on their national market presentation, only to find overseas comparators are not available. It's crucial to acknowledge that the study supply universe is a patchwork of individual players, requiring a thorough analysis of sourcing conditions and market entry or exit procedures.


How can Komtur help address the uncertainties presented by this patchwork nature? We’re risk averse, conservative, with a sober analysis of the market realities, conducting a general feasibility and


Clinical Trials Insight / www.worldpharmaceuticals.net


risk analysis. A supply scenario based on full central sourcing, which looks best in terms of costs and supply stability, might end up much more complex after a closer look at the destination countries; not an issue unique to Asia. But we’ve also seen study supplies start with a full scale regional sourcing approach and turn into a semi-central supply campaign. We are able not only to give advice on how to achieve a solution which works best for our clients, we can actually execute the supply plan too. Our value comes not only from our regional supplier and depot partner network, but our long-standing supply agreements and trusted preferred partnerships with multinational manufacturers, each of whom we have long-standing relationships with and trust.


In addition to your facilities in Shanghai, you’ve opened a second branch in China. What are the strategic implications of this investment? With the new wholesale site, we are finally able to offer clients full domestic access to almost any type of comparator drug product. Ever since Komtur came to China, it was our intention to build an independent wholesale branch. Unsurprisingly, this took much longer than anywhere else in the world; but our long-shot attitude paid off.


In October 2022, we opened Komtur Pharmaceuticals (Ahnui) Co., Ltd, the youngest member of our global branch network and currently the only wholly foreign owned NMPA/China-GSP certified pharmaceutical wholesaler in the country.


Our additional special licenses for medical devices class I–III and medical nutrition products, offer clients a ‘toolbox’ of study supplies from which they can choose the perfect fit for their clinical trial. Comparator drugs – biologics, chemicals, insulins or hormone products – can be sourced from anywhere in China, either as standalone solutions or tailor-made combinations with complementary devices, or even in the supply of animal health products if required. For Chinese clients, we offer an integrated service package, combining local supplies with additional service support from the Komtur group, such as QP release import service for studies within the EU or vice versa IOR solutions for medicinal products to be imported into China.


Given Asia’s market dynamics and the continuing evolution of Komtur, what’s next?


From a global perspective, we’ll see a stronger integration of services to increase efficiency and create synergies; of particular importance for clients who run complex multi-country trials. For APAC we’ll focus on the growth of our new China operation and further integrate it into our global network. As always, we’ll carefully analyse future service requirements and adjust our investments in the region in line with the global strategy. However, our core business philosophy – to offer clinical sourcing solutions with the patient at the heart of our everyday work – is the one thing that won’t change. ●


www.komtur.com 29


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