China Sky One Expands Pipeline With Eight New Tests in Clinical Trials

China Sky One Medical (CSKI.OB) will begin clinical tests of eight new diagnostic products next month. The tests, which will begin in August, are slated for completion before the end of this year.

The products include:

Rapid diagnosis kit for urine microalbumin;

Urine test for determining the ovulation cycle;

Rapid detection of prealbumin;

Rapid detection kit for APO B;

Rapid detection kit for APO A1;

Rapid detection kit for magnesium ion;

Semi-quantitative test for uterine cancer; and

Semi-quantitative test of calcium ion.

The uterine cancer test is classified as a Class-III medical instrument, while the others are Class-II instruments. For the Class-II tests, the clinical trials must involve a minimum of 2 provincial hospitals and 200 patients. The Class-III trial will enroll at least 1000 patients in 3 or more provincial hospitals, and it will seek approval from the China State Food and Drug Administration. The Class-II approvals will come from the Heilongjiang Food and Drug Administration.

Earlier this year, China Sky One Medical launched an AMI diagnostic kit, a human urinary albumin Elisa kit and an early pregnancy diagnostic kit. In May, the company estimated it will produce $5.5 million of profits on revenues of $14 million in its fiscal second quarter. According to Yanqing Liu, CEO and President of China Sky One, diagnostic kits currently represent a market of between 3 billion RMB and 4 billion RMB ($380 million to $512 million) in China, and the numbers are expected to increase 20% annually.

China Sky One Medical is a Nevada corporation that operates through three subsidiaries: American California Pharmaceutical Group, Inc., Harbin Tian Di Ren Medical Science and Technology Company, and Harbin First Bio-Engineering Company Limited. The company specializes in over-the-counter healthcare products.

Disclosure: none.