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SFDA grants approval for clinical studies to benapenem
Sihuan Pharmaceutical Holdings Group Ltd., a 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, 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 cost-efficient, thus lowering drug costs and benefiting 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 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 resistance 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 centralized 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.

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