Sihuan's Roxatidine passes Chinese SFDA on-site inspection

May 25 2012

Sihuan Pharmaceutical Holdings Group Ltd. (HKEx: 0460) ("Sihuan Pharmaceutical" or the "Company"), a leading pharmaceutical company with the largest cardio-cerebral vascular drug franchise ("CCV") in China's prescription market, announced that Roxatidine Acetate Hydrochloride for Injection ("Roxatidine"), Sihuan Pharmaceutical's first-to-market generic drug, recently passed on-site inspection for drug registration conducted by the Chinese State Food and Drug Administration ("SFDA"). Expecting to obtain approval for production in the next three months, the Company plans to launch the drug to the market in the second half of the year, with hospitals as its major target market. It will be manufactured by Beijing Sihuan Pharmaceutical Co., Ltd., a wholly-owned manufacturing subsidiary.

Roxatidine is the fourth generation H2 receptor antagonist. The drug is categorized into two formulations - oral and injectable. The oral form of the drug was first launched in Japan in 1986 and is mainly used for gastric and duodenal ulcers, zollinger-ellison syndrome, reflux esophagitis and gastritis. The injectable form of the drug, which debuted in Japan in, is mainly used for upper gastrointestinal bleeding and pre-anesthesia application. Currently, Roxatidine is widely used in various countries, including Korea, Germany, Italy, the Netherlands, Greece and South Africa.  

Compared with other H2 receptor antagonists, the Roxatidine contains higher selectivity for H2 receptors and features a stronger effect on acid suppression. In addition, it contains a protective mucosal effect that other H2 receptors do not have. Although the Roxatidine has similar therapeutic efficacy to Proton pump inhibitors, it is safer, more stable and more cost-effective. These outstanding advantages are a testament to Roxatidine's clinical value. As a result, Roxatidine has been the first-line drug used for upper gastrointestinal bleeding in the overseas markets.

Gastrointestinal ulcers and bleeding is a common disease in China and has a significant patient base. With the fast-paced living environment, accelerated urbanization and the persistently high stress levels, the incidence rate of such diseases has been increasing each year. Overall incidences of digestive diseases afflict 10% - 20% of the total population and have high recurrence rates. As at the end of 2011, the size of the market has reached RMB$25 billion, bringing promising market potential and prospects.

Dr. Che Fengsheng, Chairman and CEO of Sihuan Pharmaceutical, said, "Capitalising on the characteristics and advantages of Roxatidine, along with Sihuan Pharmaceutical's strong sales and marketing capabilities and nationwide sales network, we believe that this drug will bring its clinical therapeutic value into play with wide clinical use. Building on its leading position in the CCV drug market, Sihuan Pharmaceutical's launch of Roxatidine signifies Sihuan Pharmaceutical's foray into the digestive system therapeutic area. This strategic move is set to further promote the continued development and growth of Sihuan, thereby creating lucrative returns for the Company and its shareholders."