Chinese FDA clearance opens door on fast-growing Asian market

Clearance from Chinese authorities has paved the way for a South Tyneside pharma firm to significantly boost sales in Asia

Patrik Dahlen of Immunodianostic Systems in Boldon, Tyne in Wear
Patrik Dahlen of Immunodianostic Systems in Boldon, Tyne in Wear

Pharmaceutical firm Immunodiagnostic Systems Holdings is poised to grow sales in one of the world’s biggest markets after getting clearance from Chinese authorities to sell its medical testing system.

The Boldon-headquartered business, which creates testing kits for the clinical and research markets, recently announced a detailed five-year strategic growth plan in which it outlined plans to push into emerging markets in China and Brazil.

The announcement follows the firm’s appointment of Beijing Leadman Biochemistry Technology Co as distributor for its revolutionary IDS-iSYS product, an automated testing kit which can diagnose a range of diseases within hours.

The firm devised the iSYS - the Speciality Immunoassay System – in direct response to the increase in the ageing population throughout the world, which has led to increasing incidences of conditions such as osteoporosis, rheumatoid and osteoarthritis and cardiovascular disease.

The system can analyse bones, growth, cartilage and hypertension, which can aid global health authorities’ need to diagnose disease onset much earlier.

The company, which has 324 staff across the group, has targeted Asia as a fast-growing market, estimating the Chinese market for immunodiagnostics to be worth around £700m and growing at approximately 15% a year.

Turnover for the business stood at £52.3m for the year ended March 2014, a 5% rise on the previous year, and a breakdown showed revenues for the rest of the world, encompassing China, grew at twice that rate to £7.33m.

Developments in China could now grow that proportion significantly, after the firm received notice that the China Food and Drug Administration (CFDA) has approved its IDS-iSYS automated testing instrument for sale in the Chinese market.

The next stage for the firm – which operates manufacturing sites at Boldon, Belgium and France as well as four sales offices in France, Germany, here in the North East and the US – is to get clearance for the automated assays for use on the IDS-iSYS.

Since May 2013 the firm has been working with Beijing Leadman on combining both firms’ portfolios of diagnostic tests – immunoassays – onto the IDS-iSYS device, many of which are for conditions prevalent in Asia.

Leadman has made good progress in converting 30 of their main immunoassays and wants to convert a total of 50, a number of which has commercial opportunities outside of China.

The firm has now announced that it expects to get CFDA approval for the first 30 Leadman assays by the final quarter of this year.

Patrik Dahlen, chief executive office of IDS, said: “We are delighted to receive the CFDA clearance of the IDS-iSYS instrument within our projected timeframe. This approval is a key milestone in allowing us to access the large and fast growing Chinese diagnostic market.

“The next step is to gain CFDA approval for the automated assays for use on the IDS-iSYS and we continue to work closely with our Chinese partner, Leadman, in order to achieve this.”


David Whetstone
Culture Editor
Graeme Whitfield
Business Editor
Mark Douglas
Newcastle United Editor
Stuart Rayner
Sports Writer