HONG KONG, March 11, 2012 /PRNewswire-Asia/ -- Sihuan Pharmaceutical Holdings Group Ltd. (HKEx: 0460) ("Sihuan Pharmaceutical" or the "Company"), a leading pharmaceutical company and the largest cardio-cerebral vascular drug franchise in China by market share, announced today that its application to register Tylerdipine Hydrochloride, the Company's first international and innovative anti-hypertensive drug developed by its in-house research and development ("R&D") team, has been officially accepted by the Chinese State Food and Drug Administration ("SFDA") (Acceptance No.: CXHL1100774 and CXHL1100775). The application acceptance is an important step and significant achievement for the Company and comes on top of its approval to conduct clinical trials for its internally developed anti-infective drug Apapenem Carbapenems earlier this year.
Tylerdipine Hydrochloride, a class 1.1 chemical drug which is an innovative patented calcium channel blocker for the treatment of hypertension, features a novel molecular structure and independent intellectual property right. As the Company's first international and innovative drug to apply for both domestic and overseas registration, the Company aims to apply for Investigational New Drug ("IND") with the U.S. Food and Drug Administration ("FDA") in 2012. The drug is expected to receive permission for clinical trial in China by the end of 2013.
Results from pre-clinical studies have shown that Tylerdipine Hydrochloride is a superior agent in blocking L-type and T-type calcium channels. The Company believes Tylerdipine Hydrochloride can effectively curb hypertension in clinical practice while offering protection to important organs such as the heart and kidneys. Meanwhile, it would significantly reduce the cost of treating hypertension, presenting high value in clinical practice. More importantly, Tylerdipine Hydrochloride is more effective than the current anti-hypertension drugs, based on certain pr