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


10/10/2013 9:56:08 AM

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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.



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