Enigma Diagnostics announces Joint Venture Agreement with Beijing Leadman Biochemistry and a US$50M investment

Salisbury, UK, and Beijing, China, 22nd October 2014: Enigma Diagnostics Ltd (Enigma), a global leader in molecular diagnostic point-of-care (PoC) infectious disease testing, and Beijing Leadman Biochemistry Co., Ltd. (Beijing Leadman) (SZSE:300289), today announced they have signed a joint venture agreement to support the growing healthcare needs of China’s population. Under the terms of the agreement Beijing Leadman will be Enigma’s exclusive joint venture partner, with the principal goal of delivering the Enigma® Mini Laboratory (“Enigma ML”) PoC molecular diagnostic system to the Chinese market. Enigma will further license its technology and IP to the joint venture, enabling it to develop relevant molecular assays, other products and instruments for the Chinese market and to undertake in-China manufacturing.

Enigma Diagnostics also announced it has signed a US$50 million subscription agreement with Chinese private equity fund Shanghai Debay Capital LLP, an SPV company incorporated for the single investment from Sailing Capital of Shanghai. The funding will be deployed over 18 months and will be used to support global commercialization by Enigma of the Enigma® ML system following its CE marking in early 2014.

The Enigma ML’s highly accurate and multiplex assay reporting capabilities enables time-sensitive PoC testing for the widest range of DNA and RNA disease targets, with a fast turnaround time. The unique features of the system offer a hybrid laboratory and stand-alone diagnostic testing platform, designed to be used in developed and emerging healthcare programs. Easy to use, with on-board data handling and networking capability enabling multiple data sharing routes, the fully automated system requires simple training and has shown nil operator variance in recent trials. The Enigma ML provides a major advantage in laboratories or diverse testing locations where testing is undertaken by several different operators.

The Enigma ML enables markets with rapidly expanding healthcare systems the opportunity to build a diagnostic healthcare architecture which is cost-effective and patient-centric across multiple testing sites, unconstrained by traditional laboratory costs and limited physician availability. The data handling and routing capabilities allow physicians access to patient data securely and remotely, ensuring fast and accurate diagnosis with immediate and relevant treatment for patients. Enigma Diagnostics was founded in 2004 to develop and commercialize technology and IP from the UK Government’s Defence Science and Technology Laboratory (Dstl).

John McKinley, Chairman of Enigma Diagnostics, said: “This agreement with Beijing Leadman is central to Enigma’s global commercialization plans and, in particular, to its intended leadership of China’s Point-of-Care market. The joint venture will deliver an exclusive China market sales distribution, a new Chinese based R&D program using Enigma’s IP, technology and know-how, and, in the longer term, a

manufacturing capability to satisfy the expected high level of demand for our flagship ML system and assays in China and worldwide. The new investment recognizes Enigma’s potential to be the leading force in global PoC testing.”

Mr. Shen Guangqian, Chairman of Beijing Leadman Biochemistry, commented: “This joint venture with Enigma is a very important part of Leadman’s future strategic plan. It is a statement that Beijing Leadman is stepping into the molecular diagnostic field, the most rapidly growing IVD subcategory in Chinese and global markets. Combining Enigma’s ML System, products and technologies, with Beijing Leadman’s commercialization expertise, R&D and manufacturing capability, the two firms envision the joint venture to become the leading molecular diagnostics company in China. The joint venture will also serve as a bridge to promote Beijing Leadman’s products in global markets and to import advanced healthcare technologies to service the needs of the Chinese market.”

Brian Gallagher, Counsellor Commercial at the British Embassy in Beijing, and Strategic Director for Life Sciences, Health and Social Care for UKTI China, commented: “I very much welcome this landmark agreement between Enigma and their Chinese partners, it is an excellent example of the kind of co-operation that UKTI is working to promote between UK expertise in the health and life sciences industries and Chinese counterparts. In the rapidly developing healthcare sector this cooperation will make a valuable contribution to delivering better diagnostic and health services to the people of China.”


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