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news.BMP Sunstone has announced that its clinical trial application for Enablex was officially accepted by China's State Food & Drug Administration.
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Clinical trial application acceptance is a key China’s State Food & Drug Administration (SFDA) requirement prior to pursuing a clinical trial and, ultimately, completing commercialization of a pharmaceutical product in China.
The company hopes to begin the clinical trial in the first half of 2009, and estimates that receipt of a market license could occur sometime in 2011.
In November 2007, BMP Sunstone signed an exclusive agreement to register, market and distribute Enablex in the People’s Republic of China with Shanghai Novartis Trading. Under the terms of the agreement, once approved, BMP Sunstone will have the exclusive rights to sell, market and distribute Enablex in China for 10 years.
Enablex is a prescription medicine used in adults to treat symptoms of urinary incontinence, urgency and frequency related to an overactive bladder.
David Gao, CEO of BMP Sunstone, said: “Enablex is a great example of our ability to target under-penetrated areas of China with drugs that improve the overall health of the population. We intend to continue to bring high value, niche-focused prescription drugs, with rigor and prudence, to the growing Chinese healthcare market.”