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Four Botanical Small-molecule Products Approved as Drugs by the Ministry of Health, Republic of Georgia
Based on selective metabolite compound drug technology (SMCD), Pegasus developed Dammarane Sapogenins anti-cancer drug of HemoMexI ™ injection; based on a self-microemulsifying drug delivery system (SMEDDS) innovative formulation technology of oral bioavailability enhancement technology (OBET) and high efficient anti-cancer active ingredient, Pegasus developed HemoMex S™ oral soft capsule. After a series of clinical trials at the National Cancer Center of Republic of Georgia in accordance with the strict GCP standard used internationally, they were proven to be safe and effective. On Nov 17, 2008, the two products had past the evaluation of the Ministry of Health, Republic of Georgia and were approved as cancer standard treatment prescription drugs. They can be used alone or in combination with chemotherapy and / or radiotherapy, and can treat leucopenia induced by chemotherapy and / or radiotherapy as well. At the same time, Pegasus' other two oral products, Cardio Guard ™ Soft Capsule (a proprietary high-dose formula, extracted naturally highly purified ginseng saponins, used for coronary heart disease and other cardiovascular diseases), and Lipo-Aid ™ capsule (a natural extract of red yeast rice and ginseng complex proprietary formula, used for regulating dyslipidemia), were approved as non-prescription drugs. The approval of HemoMex I™ injection and HemoMex S™ oral soft capsule as anti-cancer standard prescription drugs in the Republic of Georgia marks an important milestone in the drug development of Pegasus. It's a stepping stone for the drug applications ongoing in the CIS countries, as well as for preparing the drug applications to the U.S. FDA and EMEA of European Union. Pegasus has started new drug application procedures to the FDA and EMEA. Figure 1. Mr. James Jingtao Cao, General Manager, Pegasus Pharmaceuticals Group Inc. (left); Dr. Sherman Shumin Zhao, Clinical Project Manager, Pegasus Pharmaceuticals Group Inc. (right); Dr. Razo Gagua, Professor, General Director of the National Cancer Center, Republic of Georgia (middle). Figure 2. Mr. James Jingtao Cao and Dr. Sherman Shumin Zhao, General Manager and Clinical Project Manager of Pegasus Pharmaceuticals Group Inc. are discussing about clinical trial protocols with medical doctors from the National Cancer Center, Republic of Georgia. Figure 3. One of the patients enrolled in the clinical trial of "PandiMex as Inhibitor of Bone Marrow Suppression Induced by Radio- and Chemotherapy". |




