China Sky One Medical, Inc., one of the leading producers and distributors for external-Chinese medicine in China, has announced that the Human Urinary Albumin Elisa (Nachrichten) Kit has passed the final stages of national inspection and received the new drug certificate. The State Food and Drug Administration (SFDA) classifies this medical testing device as a drug, therefore it must pass stringent testing guidelines in order to receive the new drug certificate. The kit will be distributed through hospitals, health check-up centers and sales agents.

'The approval process for all new drugs in China is a very complicated process,' stated Dr. Liu Yan-Qing, Chief Executive Officer and President of China Sky One Medical, Inc. 'The Chinese government controls and inspects all drugs extremely carefully and very few new drugs receive approvals each year. The Human Urinary Albumin Elisa Kit is a revolutionary new product for consumers in China and our Company is the only one who has adopted this new testing method.'

Human Urinary Albumin Elisa Kit is used for early diagnosis of nephropathy, or kidney problems. According to the China Medical Newspaper, nephropathy does not manifest obvious symptoms, but causes irreversible impairments to the kidney. There are billions of people who suffer from diabetes, hypertension, cardiovascular disease and nephritis all over the world. This diagnostic kit was created by CSKI to inform users of any major changes their kidneys may be experiencing.

Albumin in urine is the most sensitive indicator to monitor conditions of disease, including primary nephropathy, hypertensive nephropathy and diabetic nephropathy. Doctors will provide treatment to patients by monitoring the changes of albumin in urine. Currently the most popular testing method internationally for nephropathy is radiation turbidimetry. Unfortunately, this method is very costly for patients and requires expensive medical devices. CSKI adopted an enzyme linked immune method to prepare the Human Urinary Albumin Elisa Kit which is easy to use and relatively inexpensive to manufacture. The sensitivity of the Human Urinary Albumin Elisa Kit believes to be higher than the existing radiation turbidimetry method.

According to the latest data from the Ministry of Health states, China has the largest number of diabetes patients in the world, currently at 50 million people and the number of new patients is quickly increasing by 1.5 to 2.0 million each year. More than 60% of patients are unaware of their disease until the middle or late stage of diagnosis when the disease appears on organs such as the heart, eye, kidney etc. With the rise of living standards in China, early health physical examination has become more and more popular. Therefore, the Company believes the demand for the Human Urinary Albumin Elisa Kit will be substantial, because the kit is cost effective and an accurate tool for early disease detection.

In order for a drug to pass national inspection and granted a certificate of approval, the Company must complete the following procedures. First, the Company submits an application for the drug to the Heilongjiang Provincial Food and Drug Administration (PFDA). Then the Provincial Drug Inspection Institute takes multiple samples of the drug and sends them to the National Biology Products Inspection Institute (NBPI) for testing. During this testing time, the PFDA will also do field observation by taking drug samples and sending them to both the National Food and Drug Administration (NFDA) and the Examination and Appraisal Center for additional testing. Subsequent to receiving the test report from the NBPI, if the sample is approved by the Examination and Appraisal Center, a certificate will be granted to The Company to begin manufacturing and selling the product.

Source:佚名