Updated on 18 July 2013
Good news for gastric ulcer patients - Sihuan Pharma gets China SFDA nod for Anaprazole Sodium
Singapore: China-based Sihuan Pharmaceutical's Anaprazole Sodium has received approval for clinical studies from State Food and Drug Administration (SFDA) in China.
Anaprazole Sodium is the fifth Category I innovative drug for which the company received approval for clinical studies. Applications for patents have already been made in China, the US, Japan and Europe.
Anaprazole Sodium is a new generation of proton pump inhibitors (PPIs) which treats ulcers by inhibiting gastric acid secretion and eradicating Helicobacter pylori. Preclinical studies have shown that the new drug covalently binds to proton pump, thus providing substantially stronger and longer inhibitory effects when compared to other PPI drugs, traditional H2-receptor antagonists and antacids currently available in the market. Therefore, it can effectively treat various gastric acid diseases.
Dr Che Fengsheng, chairman and CEO, Sihuan Pharmaceutical, said that, "Further to getting clinical trial approval for Benapenem and Imigliptin Hydrochloride, the Company has once again succeeded in having clinical approval for Anaprazole Sodium, another innovative drug, demonstrating the continuous enhancement of its R&D capabilities. Anaprazole Sodium will offer physicians and patients better treatment options after its launch, and will vigorously drive the development of the company in the field of digestive system."
"This follows the launch of Roxatidine, an exclusive first-to-market generic drug this year. This will further consolidate the diversified product lines of the Company and drive its sustainable growth. Looking into the future, we will continue to bring our strong research and development capabilities into full play by developing more innovative drugs, so as to further inject new momentum into the company's development," he added.