China Sky One Resumes Flurry of Product Development Activity

China Sky One Medical, Inc. (NSDQ: CSKI) was granted production approval from the SFDA to market calcium folinate injection, an auxiliary therapy for sprue (a disease of the small intestine), malnutrition, pregnancy- or infancy-related megaloblastic anemia, and colonic and rectal cancer. China Sky One anticipates the new product will be available in June 2009. Although China Sky One has traditionally focused on externally applied OTC products, it has been moving toward prescription drugs, some of which are injected.

At the same time, the company said the SFDA granted approval to begin clinical trials of two TCMs: Paeonol gel and Mei Lu gel. The two TCMs are both dermatological prescription drugs.

Paeonol gel is an anti-allergic, anti-pyretic and anti-itch medicine used for the treatment of eczema, dermatitis and skin diseases caused by insect bites. It can also be used for allergic rhinitis and prevention of colds. Mei Lu gel treats Acne vulgaris and relieves itching. It also treats eczema and dermatitis solaris, and it repels insects.

China Sky One expects the clinical trials for the two gels will take about six months to complete, with final SFDA approvals following in 2010.

China Sky One ended calendar 2008 with an unbelievable flurry of new product approvals and corporate developments. It has been less newsy during the early months of 2009, but now seems to have emerged from hibernation, a period of quiet that lasted only two months.

Disclosure: none.