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.