NeoStem’s cGMP approval finds favour with investors

By Wai Lang Chu

- Last updated on GMT

Suzhou Erye, a subsidiary of NeoStem Pharmaceutical, has passed inspection by the Chinese Food and Drug Administration (SFDA) meaning the company's new manufacturing facility will go ahead with the manufacture of penicillin and cephalosporin powder for injection.

The approval of its two current good manufacturing practice (cGMP) factory lines sent investors in a state of frenzy as news of NeoStem’s announcement means its already healthy revenue stream from these products are set to rocket in production numbers.

The new facility is predicted to increase capacity by more than 50 per cent. Coupled with the approval of the lines earlier in 2010, Erye said it had relocated over 90 per cent of its 2009 sales to the new facility, placing its plans ahead of schedule.

"Erye's relocation of these two additional production lines to the new facility will increase capacity in the near term by more than 50 per cent, bringing Erye another step closer to its goal of becoming one of the largest antibiotic producers in Eastern China,"​ said NeoStem’s Chairman and CEO, Robin Smith.

The antibiotics market in China was worth approximately $8.8bn in 2007, with an annual average growth rate of approximately 24 per cent for the previous three years. The overall pharmaceuticals market in China is forecasted to triple in size by 2013, to become the third largest drug market in the world, behind the US and Japan.

Stem cell therapies

NeoStem’s jewel in its ever-expanding product line however is the highly advanced range stem cell therapies it has been readying for the commercialisation for the last few years.

NeoStem is one of the pioneers in stem cell therapy, particularly in Asia. For example, over the last two years the firm has established collaborations in China to utilise the country’s progressive stem cell environment and launch stem cell therapeutic procedures in orthopaedics and anti-aging.

It’s activities concerning its adult stem cell collection centres in the US are also noteworthy, particularly its establishment of an R&D laboratory in Cambridge, Massachusetts and collaboration with ImmuneRegen Biosciences focused on the development of an advanced, adult human stem cell product.

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