HONG KONG, March 11, 2012 /PRNewswire/ --
- Chinese State Food and Drug Administration accepts IND application of the Company's first self-developed innovative anti-hypertensive drug
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 pre-clinical trials such as acute anti-hypertensive trials and chronic administration anti-hypertensive trials. In pre-clinical pharmacokinetic/pharmacodynamic ("PK /PD") studies, Tylerdipine Hydrochloride reported long-term efficacy. Its safety has also been ensured in animal testing.
According to the METNET and National Health Services Survey, over 200 million Chinese suffer hypertension, a number that grows by more than 3 million each year. Overall treatment costs exceed RMB40.0 billion per year which included over RMB30.1 billion for anti-hypertensive drugs in 2011 (according to IMS data), constituting a huge market with enormous potential. Calcium channel blockers are the best-selling type of anti-hypertension drugs. Tylerdipine Hydrochloride differentiates itself from other Calcium channel blockers by its higher efficacy and ability to treat hypertension while protecting important organs such as the heart and kidneys, a function unseen in similar products. The Company expects that once registered, this product would be its first international innovative drugs and become a flagship product in the anti-hypertension therapeutic area and further contribute to Sihuan's leading position in the CCV market.
Dr. Che Fengsheng, Chairman and CEO of Sihuan Pharmaceutical, said, "We are pleased to announce the recent acceptance of our application for Tylerdipine Hydrochloride by the SFDA and believe it, in addition to the success we have had with Apapenem Carbapenems, represents a significant achievement for our R&D team. R&D is an important contributor as we further expand and optimize our product portfolio. We continue to invest in the development of innovative and first-in-market drugs and explore other growth sectors. One particular interest is in the field of biopharmaceuticals, represented by therapeutic antibodies, a key focus area of China's 12th Five-Year Plan. The Company has established a world-class R&D team in biopharmaceuticals, targeting to develop new antibody drugs for the treatment of cancers and auto-immune diseases. Leveraging our proven high-end biomedical R&D and production capabilities, we will continue to enrich our product pipeline by establishing our own in-house technological platforms in the emerging biotechnology fields. We are determined to expand our R&D capability to ensure Sihuan Pharmaceutical's sustainable growth."
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 by market share. The success of the Group 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. The company currently sells 87 products encompassing the top five medical therapeutic areas in China: cardiovascular system, anti-infective, metabolism, oncology and nervous system. Their major products such as Kelinao, Anjieli, Chuanqing, Qu'Ao and Aogan are widely used in the treatment of various cardio-cerebral vascular diseases.
