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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 no drug-drug interactions as well as less side-effects on gastrointestinal, cardiovascular and respiratory systems than drugs currently available in the market. In addition, its single isomer regiment provides additional quality and predictability. The above advantages will provide a favourable market potential for Anaprazole Sodium. 

Gastrointestinal ulcers and gastric motility disorders are common in China and have a significant patient base. With the fast-paced living environment, accelerated urbanisation and the persistently high stress level in China, the incidence rates of such diseases have been increasing each year. The overall incidences of digestive disease afflict 10%-20% of the total population, and the recurrence rate of gastrointestinal ulcers is above 75%. According to MENET figures, the size of the market has exceeded RMB$27.0 billion as at the end of 2012. This brings promising market potential and prospects.

Dr. Che Fengsheng, Chairman and CEO of Sihuan Pharmaceutical, said, "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. "

About Sihuan Pharmaceutical Holdings Group Ltd.

Founded in 2001, Sihuan Pharmaceutical Holdings Group Ltd. is a leading pharmaceutical company and the largest cardio-cerebral vascular drug franchise in China's prescription drug market by market share. The success of the Company can be attributed to its differentiated and proven sales and marketing model, diversified portfolio of market leading drugs, extensive nationwide distribution network, and strong research and development capabilities. Sihuan Pharmaceutical major products such as Kelinao, Anjieli, Chuanqing, Qu'Ao, GM1 and Oudimei are widely used in the treatment of various cardio-cerebral vascular diseases.


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SOURCE Sihuan Pharmaceutical Holdings Group Ltd.
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