Sihuan Pharmaceutical Secures SFDA Approval for Anaprazole Sodium Category 1.1
New Drug Clinical Studies
Further consolidates the diversified product lines to drive sustainable growth
HONG KONG, July 17, 2013
HONG KONG, July 17, 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 Anaprazole
Sodium, a Category 1.1 new drug received the Approval for Clinical Studies
from the State Food and Drug Administration ("SFDA") of the People's Republic
of China. Anaprazole Sodium is the fifth Category 1 innovative drug in respect
of which the Company has received approval for Clinical Studies, applications
for patents have been made in China, the United States, Japan and Europe.
Anaprazole Sodium is a new generation of proton pump inhibitors ("PPIs") which
treats ulcers quickly and efficiently by inhibiting gastric acid secretion and
eradicating Helicobacter pylori. Preclinical studies have shown that the new
drug covalently binds to proton pump, thus providing substantially stronger
and longer inhibitory effects when compared to other PPI drugs, traditional
H2-receptor antagonists and antacids currently available in the market.
Therefore, it can effectively treat various gastric acid diseases.
According to MENET figures, PPIs, with a sales of RMB21.9 billion as at the
end of 2012, is the best-selling drug category for treating gastrointestinal
ulcers. By inhibiting H+-K+exchange conducted by the proton pump located on
the membrane of parietal cell lining stomach wall, PPIs blocks the last step
in the synthesis of gastric acid and inhibits the secretion of gastric acid.
Preclinical data showed that Anaprazole Sodium is safer and possess the
properties of rapid onset, stronger and longer duration of acid inhibition.
Its metabolism is achieved through various enzymes, with minimal or no
drug-drug interactions as well as less side-effects on gastrointestinal,
cardiovascular and respiratory systems than drugs currently available in the
market. In addition, its single isomer regiment provides additional quality
and predictability. The above advantages will provide a favourable market
potential for Anaprazole Sodium.
Gastrointestinal ulcers and gastric motility disorders are common in China and
have a significant patient base. With the fast-paced living environment,
accelerated urbanisation and the persistently high stress level in China, the
incidence rates of such diseases have been increasing each year. The overall
incidences of digestive disease afflict 10%-20% of the total population, and
the recurrence rate of gastrointestinal ulcers is above 75%. According to
MENET figures, the size of the market has exceeded RMB$27.0 billion as at the
end of 2012. This brings promising market potential and prospects.
Dr. Che Fengsheng, Chairman and CEO of Sihuan Pharmaceutical, said, "Further
to getting clinical trial approval for Benapenem and Imigliptin Hydrochloride,
the Company has once again succeeded in having clinical approval for
Anaprazole Sodium, another innovative drug, demonstrating the continuous
enhancement of its R&D capabilities. Anaprazole Sodium will offer physicians
and patients better treatment options after its launch, and will vigorously
drive the development of the Company in the field of digestive system. This
follows the launch of Roxatidine, an exclusive first-to-market generic drug
this year. This will further consolidate the diversified product lines of the
Company and drive its sustainable growth. Looking into the future, we will
continue to bring our strong research and development capabilities into full
play by developing more innovative drugs, so as to further inject new momentum
into the Company's development. "
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
Company 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: Angela Kung, (852) 2894 6374 / 6017 7030,
firstname.lastname@example.org; or Crystal Yip, (852) 2894 6211 / 9720 6445,
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