Sihuan’s First-to-market Generic Drug Roxatidine Receives Certificate and Approval for Production

2012-10-31 09:30:15  Copyfrom: Sihuan Pharmaceutical Holdings Group Ltd.

HONG KONG, 31 October 2012 – 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, is pleased to announce that Roxatidine Acetate Hydrochloride for Injection (“Roxatidine”), Sihuan Pharmaceutical’s first-to-market generic drug, received a new drug certificate and approval for production. The Company plans to launch the drug to the market in or before the first quarter of next year. 


Sihuan Pharmaceutical is the first pharmaceutical company to successfully register and develop Roxatidine in China, and has four years of administrative protection for the drug. Roxatidine is a 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 1995, is mainly used for gastrointestinal ulcers and bleeding and pre-anesthesia application. It is one of the few drugs prescribed in hospitals to treat inpatients suffering from gastrointestinal bleeding. Currently, Roxatidine is widely used in various countries, including Korea, Germany, Italy, the Netherlands, Greece and South Africa.   


Dr. Che Fengsheng, Chairman and CEO of Sihuan Pharmaceutical, said, “Roxatidine has a high clinical value. Based on the hospital retail price, the market size of the same type of drug has already reached RMB$1 billion. Leveraging our strong marketing capabilities and nationwide sales and distribution network, we believe that the official launch and manufacturing of Roxatidine will not only optimize our product mix, but will also strengthen our competitiveness and help us develop the market for therapeutic drugs for the digestive system. Looking forward, we will continue to invest in research and development in order to strengthen our leading position in the CCV drug market. Meanwhile, we will seize opportunities in other therapeutic areas to further boost the continued development of Sihuan, thereby creating lucrative returns for the Company and its shareholders.


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 in China, the incidence rates of such diseases have been increasing each year. The overall incidences of digestive diseases afflict 10% - 20% of the total population, and the recurrence rates are high. As at the end of 2011, the size of the market has reached RMB$25 billion, bringing promising market potential and prospects. 

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