CFDA Accepts Sihuan Pharmaceutical's Application for Clinical Trial Approval for Self-Developed Innovative Oncology Drug

 CFDA Accepts Sihuan Pharmaceutical's Application for Clinical Trial Approval
            for Self-Developed Innovative Oncology Drug Pirotinib

To further consolidate diversified product lines to drive sustainable growth

PR Newswire

HONG KONG, Oct. 10, 2013

HONG KONG, Oct. 10,2013 /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 application it
had submitted for Clinical Trial Approval of Pirotinib, a Category 1.1
Innovative Drug developed by the Company's innovative drug research and
development ("R&D") team, was accepted by the China Food and Drug
Administration ("CFDA") (IND filing numbers 1300995 and 1300996). Sihuan
Pharmaceutical's first self-developed oncology drug, Pirotinib, is another
milestone in the Company's development of innovative drugs as it signifies the
Company's capability to tap the oncology products market.

Pirotinib is a second generation (pan-HER) inhibitor for the treatment of lung
cancer and breast cancer. Its preclinical studies demonstrate that the drug
has unique profiles in pharmacology, pharmacokinetics and toxicology, and
features a developable property. The Company's scientific research team is
currently evaluating the possibility of filing an application for FDA approval
in the United States. In addition, the Group, having submitted applications
for international patent rights for Pirotinib, has entered the evaluation
process in China, the United States, Japan and Europe.

Dr. Che Fengsheng, Chairman and CEO of Sihuan Pharmaceutical, said, "According
to statistics from MENET, the oncology drug market is one of the largest drug
markets in China with a market scale exceeding RMB 66.7 billion at the end of
2012. Lung cancer is the top tumour disease in China, while breast cancer
ranks sixth, with mortality rate increasing in recent years. Pirotinib, as a
unique innovative drug designed to cure lung cancer and breast cancer
featuring competitive rates of efficacy, has strong market potential. It may
also provide physicians and patients better treatment options and will drive
the development of the Company in the field of oncology, which will further
consolidate the Company's diversified product lines and drive its sustainable
growth."

About Sihuan Pharmaceutical Holdings Group Ltd.

Founded in 2001, Sihuan Pharmaceutical Holdings Group Ltd. is a leading
Chinese pharmaceutical corporation and the largest cardio-cerebral vascular
drug franchise in China's prescription drug market by market share. The
Company also became the third largest pharmaceutical company in terms of
hospital purchase in the Chinese prescription drug market in the first half of
2013. The success of the Group can be attributed to its differentiated and
proven sales and marketing model, extensive nationwide distribution network,
young and diversified product portfolio, and strong R&D capabilities. The
company's current products encompass the top five medical therapeutic areas in
China: cardio-cerebral vascular system, central nervous system, metabolism,
oncology and anti-infectives. Their major products such as Kelinao, Oudimei,
Yuanzhijiu, Yeoduojia, GM1 and Chuanqing are widely used in the treatment of
various cardio-cerebral vascular diseases.

SOURCE Sihuan Pharmaceutical Holdings Group Ltd.

Contact: Hill+Knowlton Strategies Asia, Angela Kung, +852-2894-6374 /
+852-6017-7030, angela.kung@hkstrategies.com; Agnes Suen, +852-2894-6258 /
+852-9050-5406, agnes.suen@hkstrategies.com
 
Press spacebar to pause and continue. Press esc to stop.