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.
SOURCE Sihuan Pharmaceutical Holdings Group Ltd.
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