State Food and Drug Administration Grants Approval to Sihuan Pharmaceutical
for Clinical Trial of Innovative Drug -- Pinoxacin Hydrochloride
Phase I of clinical studies set to begin in the first half of 2013
Sihuan Pharmaceutical to further expand therapeutic area coverage
HONG KONG, Feb. 22, 2013
HONG KONG, Feb. 22, 2013 /PRNewswire/ -- 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, today announced that Pinoxacin
Hydrochloride, a Category 1.1 new drug developed by the Company's innovative
drug research and development team, received Approval for Clinical Studies
from the State Food and Drug Administration. Phase I of clinical studies are
set to begin in the first half of this year. It is the fourth Category 1
innovative drug for which the Company has received Approval for Clinical
Pinoxacin Hydrochloride is DPP-4 inhibitor class of oral hypoglycemic agents,
a drug with a brand new structure for treating type II diabetes. It is
clinically used to enhance the function of endogenous insulin for improving
glycemic control, and long-term use can improve islet beta-cells function.
Pre-clinical research has shown that DPP-4 inhibitors have potent in vitro and
in vivo activities, a good selection profile, great stability and controllable
quality, as well as better tolerance, with long-term administration showing a
protective effect on pancreatic beta-cells. In addition, the DPP-4 inhibitor
will not cause serious side effects such as weight gain and hypoglycaemia seen
in traditional diabetes drugs. Pinoxacin Hydrochloride has good
pharmacokinetic characteristics, high oral bioavailability, quick absorption,
rapid onset and a longer duration. A once daily dosage is expected to keep the
patients' symptoms under control. The advantages of Pinoxacin Hydrochloride
have proven the drug's growth potential present in the market.
According to statistics from IMS, in 2011, the size of China's diabetes drug
market was RMB 13.4 billion, one of the largest therapeutic areas in China.
China has an overall diabetes incidence rate of 9.7%, with the number of
patients exceeding 100 million, making China the country with the largest
number of diabetics in the world. Diabetes has also become the world's third
largest therapeutic area after CCV diseases and tumor diseases, and therefore
exhibits promising prospects.
Dr. Che Fengsheng, Chairman and CEO of Sihuan Pharmaceutical, said, "Further
to obtaining clinical approval for Benapenum, a class of new drug, in January,
the Company has again successfully obtained clinical approval for another new
drug. This has proven the Company's strengthened research and development
capabilities and that its continuous investment has started to bear fruit. We
believe Pinoxacin Hydrochloride will provide physicians and patients with
better treatment options after its launch, and will mark an important
milestone for Sihuan Pharmaceutical as it enters into another major
therapeutic area. This will enable the Company to further consolidate its
diversified product lines while driving its 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's prescription drug market 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. Sihuan
Pharmaceutical major products such as Kelinao, Anjieli, Chuanqing, Qu'Ao, GM1
and Oudimei are widely used in the treatment of various cardio-cerebral
SOURCE Sihuan Pharmaceutical Holdings Group Ltd.
Contact: Hill+Knowlton Strategies Asia, Crystal Yip, +852-2894-6211,
+852-9720-6445, email@example.com; or Ada Ho, +852-2894-6262,
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