Tianyin Pharmaceutical Co., Inc. (TPI), a pharmaceutical company that specializes in patented biopharmaceutical medicine, modernized traditional Chinese medicine, branded generics and other pharmaceuticals, announced that TPI has received the China's SFDA's approval for its anti-diabetic drug Gliclazide tablets (80 mg formulation).

Gliclazide is an oral anti-diabetic drug that is used for the control of hyperglycemia in gliclazide-response diabetes mellitus of stable, mild, non-ketosis prone, maturity-onset. It is used when diabetes could not be managed by proper dietary adjustment and exercise or when not suitable for insulin therapy.

TPI is anticipating that its Gliclazide tablets to make its market entry in July this year.

Diabetes Mellitus, or Diabetes, is a group of metabolic diseases that are featured with high blood sugar with lack of insulin, or due to cells do not respond to the insulin that is produced. This high blood sugar causes the classical symptoms: polyuria (frequent urination), polydipsia (increased thirst) and polyphagia (increased hunger). Later complications include vascular disease, peripheral neuropathy, and predisposition to infection. Treatment for Diabetes includes diet, exercise, and drugs that reduce glucose levels, such as insulin and oral antihyperglycemic drugs. Prognosis for Diabetes varies with degree of glucose control. There are two main categories of diabetes -- type 1 and type 2, which can be distinguished by a combination of features.

Gliclazide is an oral anti-diabetic (hypoglycemic) drug which is classified as a sulfonylurea. It has been marketed as Glyloc and Reclide in India and Diamicron in Canada. Gliclazide is used for control of hyperglycemia in gliclazide-responsive diabetes of stable, mild, non-ketosis prone, maturity-onset or adult type. It is used when diabetes cannot be controlled by proper dietary management and exercise or when insulin therapy is not appropriate. Gliclazide binds to sulfonylurea receptors on the surface of the Beta islet cells found in the pancreas. This binding effectively closes the potassium ion channels. This decreases the efflux of potassium from the cell which leads to the depolarization of the cell. This causes voltage dependent calcium ion channels to open increasing the calcium influx. The calcium can then bind to and activate calmodulin which leads to exocystosis of insulin vesiclesleading to insulin release.

Diabetes is one of the most common endocrine disorders in the world. The World Health Organization (WHO) estimates that worldwide, there are currently 220 million people living with diabetes. Diabetes is becoming an important chronic disease in China. In 2010, there were 95 million cases of diabetes in China, of which, 52 million and 43 million were found in rural and urban areas, respectively. By the end of 2020, it is estimated that the prevalence will increase to 117 million. The urbanization rates, obesity and population aging are several major drivers for the increasing type 2 diabetes incidence in China.

Headquartered at Chengdu, China, TPI is a pharmaceutical company that specializes in the development, manufacturing, marketing and sales of patented biopharmaceutical, modernized traditional Chinese medicines, branded generics and other pharmaceuticals. TPI currently manufactures a comprehensive portfolio of 56 products, 23 of which are listed in the highly selective national medicine reimbursement list, 7 are included in the essential drug list of China.