Medytox said Friday that it has submitted a new drug application (NDA) for Medytoxin, its botulinum toxin (BTX) type A product, to the China Food and Drug Administration (CFDA).
If approval goes as planned, the company expects to become the first domestic company to export its BTX product in China. Currently, there are only two BTX products available in China -- Lanzhou Biological Products Institute BTX-A and Allergen’s Botox.
Based on the strict guidelines of the CFDA, the company has completed clinical trials for Medytoxin and conducted statistical analysis of the clinical trial data regarding the safety and efficacy of the drug. To enter China successfully, the company has also established MedyBloom China, a joint venture with Bloomage Biotechnology Corp., and has laid out an optimal customized marketing strategy in 2015.
Future growth plans for synergy with the company’s filler products are also underway. The company has launched clinical trials for Neuramis, its hyaluronic acid filler, in China, last year.
“The beauty market in China, which is growing 20 to 30 percent annually, is an attractive market with great growth potential,” a company official said. “If the entry into China is carried out as planned, Medytox’s “Vision 2022” of achieving 1 trillion won ($917 million) in sales will come one step closer.”
Since the company has established a local joint venture with Bloomage Biotechnology Corp., which is an active player in the local beauty cosmetics market, the company expects to enjoy a preemptive market position through differentiated marketing strategies, he added.
The company has started phase 3 clinical trials in Taiwan, too.
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