AsiaGlo Ventures Interna-tional
May 2015
Joe Kim , Korea E-mail: [email protected] Phone : 82-10-2334-0780
AsiaGLOBest solution provider
AsiaGLOBest solution provider
MissionTo provide best clinical research services to sponsors by Satisfying the sponsor with
quality, time and cost and by Complying with regulatory and ethical standards.
Company OverviewAsiaGLO has focused on the development of new and innovative products/technologies by our customers, in a responsive, reliable and compliant manner.AsiaGLO is growing by professionals in the Healthcare and Pharmaceutical industry. And our teams are providing flawless outcome with professionalism. Our compliance to regulatory requirements, our dedication to high quality and punctuality will be everlasting.On these basis, AsiaGLO is also certified by KFDA Inspection.
Services- Bioavailability and Bioequivalence /Phase I and Pharmacokinetic Studies (Dose Response, Steady State, Food Effect, DDI, Pharmacoscintigraphic Imaging).- Bioanalytical Services- PK/PD Analysis and Statistical Analysis- Regulatory Affairs
AsiaGLO’s BE lab capability in
Korea
AsiaGLOBest solution provider
Connection with clinical services BioAnalytical Services
Pharmacokinetics and Statistics
AsiaGLOBest solution provider
Quality Assurance
Regulatory Affairs
Our Regulatory Affairs (RA) team is comprised of experts in drug development, approvals and manufacturing and can consult about a diverse range of services including:
-Regulatory Dossier preparation (NDA/ANDA) and submission
-Compliance audits of CROs, Manufacturing and Clinical Research Sites
-Regulatory Affairs support for post submission query resolution and responses to facilitate successful approvals.
Our QA and RA team is committed to ensuring strict compliance to regulatory standards. And our dedication to high quality, accurate results guarrantees the prompt and successful approval of our customers innovative products.
AsiaGLOBest solution provider
glimepiride biphenyl-dimethyl-dicarboxylate etodolac mirtazapine
doxycycline cefixime eperisone baclofen
diclofenac cefdinir omeprazole valsartan
lansoprazole sibutramine oxycodone cimetropium
losartan simvastatin zonisamide acetyl-L-carnitine
levofloxacin anastrozole Thioctic acid azelastine
rebamipide acebrophiline carvedilol tiropramide
enalapril aceclofenac clarithromycin tamsulosin
amlodipine maleate acetaminophen talniflumate phlorogulucinol
morniflumate donepezil HCl felodipine finasteride
montelukast lercanidipine fluconazole loxoprofen
tianeptine pregabalin dutasteride olanzapine
metformin Omega-3 acid ethyl ester olmesartan hydroclorothiazide
Validated Analytic Method
AGVI-001(Entelon) approval (Oct. 2015)Modified drug of Norvatis/Hanlim’s Entelon tablet.
Vitis vinifera extract of the European Grape Seed Extract(GSE)
in the treatment of veno-lymphatic insufficiency and diabetic retinopathy.
Osteoarthritis in 2017
Competitor : Entelon of Aventis/Hanlim Pharm.Aventis(Korean Licensee:Hanim) is only supplier in the world and sold
USD50Mil. in Korea last year and conduct the clinical study in Korea to develop
new indication (Osteoarthritis) .
It was launched in France, Russia and some European countries only because of
the limited clinical studies and used as the health supplements widely.
But Hanlim and AsiaGLO conducted the regular clinical studies for the
registration and AsiaGLO succesfully developed new pharmaceutical grade
GSE with European supplier with less side effects.
Now, we are ready to go to the Global Market!
AsiaGLOBest solution provider
AsiaGLOBest solution provider
diabetic retinopathyWhat is diabetic retinopathy?Diabetic retinopathy is the most common diabetic eye disease and a leading cause of blindness In adults. It is caused by changes in the blood vessels of the retina.In some people with diabetic retinopathy, blood vessels may swell and leak fluid. In other people, abnormal new blood vessels grow on the surface of the retina. The retina is the light-sensitive tissue at the back of the eye. A healthy retina is necessary for good vision.If you have diabetic retinopathy, at first you may not notice changes to your vision. But over time, diabetic retinopathy can get worse and cause vision loss. Diabetic retinopathy usually affects both eyes.
There are 3 drugs. Eylea is new and longer lasting and is likely to be the best for the moment, Avastin is the cheapest and almost certainly just as good as Lucen-tis which is in popular use. The procedure is discussed. The drugs reduce macular oedema and proliferation (blood vessel growth) in diabetic retinopathy, but their effect usually wears off. To keep good sight in the long term, the diabetes and blood pressure (BP) must be controlled: the drugs are very useful for use whilst patients are trying to control their diabetes and BPBut, Entelon is only drug to prevent and treat diabetic retinopathy at the moment.
How is diabetic retinopathy treated?
AsiaGLOBest solution provider
AsiaGLOBest solution provider
lymphedema
What is Lymphedema?
There are around 2.5Mil. patients in US because of the Breast surgery and no drug and
no cure. (Incidence : 20% of the breast cancer patients /uterine cervical cancer patients)
Lymphedema is an abnormal collection of high-protein fluid just beneath the skin. This swelling, or edema, occurs most commonly in the arm or leg, but it also may occur in other parts of the body including the breast or trunk, head and neck, or genitals. Lymphedema usually develops when lymph vessels are damaged or lymph nodes are removed (secondary lymphedema) but can also be present when lymphatic vessels are missing or impaired due to a hereditary condition (pri-mary lymphedema).
How is diabetic retinopathy treated?
After the breast cencer therapy
AsiaGLOBest solution provider
Osteoarthritis
Osteoarthritis is a joint disease that mostly affects cartilage. Cartilage is the slippery tissue that covers the ends of bones in a joint. Healthy cartilage allows bones to glide over each other. It also helps absorb shock of movement. In osteoarthritis, the top layer of cartilage breaks down and wears away. This allows bones under the cartilage to rub together. The rubbing causes pain, swelling, and loss of motion of the joint. Over time, the joint may lose its normal shape. Also, bone spurs may grow on the edges of the joint. Bits of bone or cartilage can break off and float inside the joint space, which causes more pain and damage.People with osteoarthritis often have joint pain and reduced motion. Unlike some other forms of arthritis, osteoarthritis affects only joints and not internal organs. Rheumatoid arthritis - the second most common form of arthritis - affects other parts of the body besides the joints. Osteoarthritis is the most common type of arthritis.estimated the global osteoarthritis therapeutics market to be valued at $5bn in 2009. It is expected to grow to $5.5bn with a compound annual growth rate (CAGR) of 1.5% by 2016. This growth is primarily attributed to the increase in ag-ing population resulting high incidence and prevalence of the disease and also pipeline product launch such as SMC021 and PF-4383119. Globally, the US re-mains the largest market for osteoarthritis therapeutics, and was valued at $2.6bn in 2009. It is forecast to grow at a CAGR of 1.6% over the next seven years to reach $2.87bn by 2016.
Market