State Food and Drug Administration Grants Approval for Clinical Studies to Sihuan Pharmaceutical's Innovative Drug -- Benapenem

  State Food and Drug Administration Grants Approval for Clinical Studies to
             Sihuan Pharmaceutical's Innovative Drug -- Benapenem

Phase I of clinical trial set to begin in first half of 2013

Blockbuster product to strengthen sustainable development of Sihuan
Pharmaceutical

PR Newswire

HONG KONG, Jan. 22, 2013

HONG KONG, Jan.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, announced that the active
pharmaceutical ingredients of and injection form of Benapenem, being a
Category 1.1 new drug developed by the KBP BioSciences Pharmaceutical
Technical Co., Ltd.(" KBP BioSciences"), a wholly-owned subsidiary of the
Company, received the Approval for Clinical Studies (2012L02703, 2012L02697)
from the State Food and Drug Administration. Phase I of clinical studies are
set to begin in the first half of this year. The drug has been patented in
China and the United States. It is the third Category 1 innovative drug for
which the Company has received Approval for Clinical Studies.

Benapenum is a carbapenem drug, being a class of broad spectrum β-lactam
antibiotics which are widely used to treat multiple drug resistance ("MDR") in
hospitals. Pre-clinical researches have shown that Benapenem has potent in
vitro and in vivo activities, a good safety profile, and a long half-life
compatible with a once daily dosing. Its efficacy is significantly better than
similar drugs such as Meropenem, which requires three doses per day and higher
amounts per dose. In addition, as compared to another similar drug-
ertapenem, benapenem has excellent chemical stability, a simple production
process and convenient storage conditions, making it to achieve
cost-efficiency, which in turn lowers drug costs and benefit the patients.

According to the statistics from MENET in 2012, the anti-infective drug market
remains the largest drug market in China, currently exceeding RMB 84 billion.
Carbapenem drugs, a class of broad-spectrum antibiotics, have been
well-received by physicians and patients for its high anti-drug resistancy. In
the first half of 2012, only six of 13 categories of antibiotics, including
Carbapenem drugs, achieved growth in drug spending at hospitals as compared to
the previous year. The growth in spending demonstrates Carbapenem's advantages
in anti-drug resistancy and treatment, translating into promising market
prospects for Benapenum.

Dr. Che Fengsheng, Chairman and CEO of Sihuan Pharmaceutical, said, "We
believe that Benapenum, an innovative drug with competitive advantages such as
a wide variety of clinical applications and cost efficient production, has
immense market potential. Once approved for marketing, the drug will provide
physicians a better option for clinical treatment, which will in turn benefit
patients."

"As we strive to enhance Sihuan Pharmaceutical's research and development
capabilities, we have been investing more resources in R&D over the years.
With the aim of further enhancing our innovative drug capabilities in order to
achieve faster and better results, we have further centralised our R&D
resources by restructuring KBP BioSciences which became a wholly-owned
subsidiary of the Group in 2012. The development of a sustained quality
product pipeline enables us to drive further growth in the prescription drug
market, thereby creating optimal value for the company and our shareholders,"
added Dr. Che.

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
vascular diseases.

SOURCE Sihuan Pharmaceutical Holdings Group Ltd.

Website: http://www.sihuanpharm.com/index.php?l=en
Contact: Angela Kung, +852-2894-6374 / +852-6017-7030,
angela.kung@hkstrategies.com; Vivienne Leung, +852-2894-6262 / +852-9167-9871,
vivienne.leung@hkstrategies.com
 
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