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Sihuan Pharmaceutical Announces 2013 Interim Results
Date:8/26/2013

e Group has received Approval for Clinical Trials for a total of five Category 1 innovative drugs from the China State Food and Drug Administration ("CFDA"), including, Benapene, Imigliptin Dihydrochloride and Anaprazole Sodium. In addition, L-Phencynonate Hydrochloride, a Category 1 innovative drug, and Cinepazide Mesilate, a Category 4 exclusive new drug are progressing as planned. The collaborative development project with NeuroVive, innovative CCV drugs CicloMulsion and Neurostat, are in progress as planned towards clinical trials. CicloMulsion is filing application for Approval for Clinical Trials in China.

For the aspect of generic drugs, after gaining production licenses for Roxatidine, a first-to-market exclusive generic drug, and Nalmefene Hydrochloride Injection, a Category 3.1 generic drug, the products successfully passed final inspections and were officially launched. Development of other Category 3.1 generic drugs in the pipeline such as Levetiracetam injection, Lacosamide, and Aprepitant are also in progress as planned. Including these three drug development projects, the Group has a total of 17 Category 3.1 first-to-market generic drug projects under development. In addition, production license applications were filed for two other generic drugs during the Period and approvals from CFDA are expected to be issued by the end of 2013.

Production and Quality ManagementIn compliance with the new Good Manufacturing Practice ("GMP") standards, upgrades of the Company's production bases in Beijing, Jilin and Liaoning are approaching completion. The Group plans to apply for new GMP standard certification in September 2013. The Company's Active Pharmacentical Ingredients production facility, Langfang Gaobo Jingband established cooperation with the largest Canadian-owned pharmaceutical company Apotex Inc. during the Period. More importantly, the
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SOURCE Sihuan Pharmaceutical Holdings Group Ltd.
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