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Sihuan Pharmaceutical Secures SFDA Approval for Anaprazole Sodium Category 1.1 New Drug Clinical Studies
Date:7/17/2013

HONG KONG, July 17, 2013 /PRNewswire/ -- Sihuan Pharmaceutical Holdings Group Ltd. (HKEx: 0460) ("Sihuan Pharmaceutical" or the "Company"), a leading pharmaceutical company with the largest cardio-cerebral vascular ("CCV") drug franchise in China's prescription market, today announced that Anaprazole Sodium, a Category 1.1 new drug received the Approval for Clinical Studies from the State Food and Drug Administration ("SFDA") of the People's Republic of China. Anaprazole Sodium is the fifth Category 1 innovative drug in respect of which the Company has received approval for Clinical Studies, applications for patents have been made in China, the United States, Japan and Europe. 

Anaprazole Sodium is a new generation of proton pump inhibitors ("PPIs") which treats ulcers quickly and efficiently 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.

According to MENET figures, PPIs, with a sales of RMB21.9 billion as at the end of 2012, is the best-selling drug category for treating gastrointestinal ulcers. By inhibiting H+-K+exchange conducted by the proton pump located on the membrane of parietal cell lining stomach wall, PPIs blocks the last step in the synthesis of gastric acid and inhibits the secretion of gastric acid.

Preclinical data showed that Anaprazole Sodium is safer and possess the properties of rapid onset, stronger and longer duration of acid inhibition. Its metabolism is achieved through various enzymes, with minimal or
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SOURCE Sihuan Pharmaceutical Holdings Group Ltd.
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