China Sky One Medical wins SFDA approval for calcium folinate injection

China Sky One Medical has obtained production approval from the State Food and Drug Administration in China for calcium folinate injection.

The company said that another two new traditional Chinese medicines, Paeonol gel and Mei Lu gel, were approved by the State Food and Drug Administration (SFDA) to enter into clinical trials. All three are prescription drugs.

Calcium folinate injection is a solution for injection intended as an auxiliary therapy for sprue, malnutrition, pregnancy- or infancy-related megaloblastic anemia, and colonic and rectal cancer. It will be available to consumers around June 2009.

Paeonol gel is a type of anti-allergic, anti-pyretic and anti-itch medicine that can be used for the treatment of eczema, dermatitis and other kinds of skin diseases caused by insect bites. Mei Lu gel is used to treat Acne vulgaris and to relieve itching. It can also be used to cure other skin diseases, including eczema and dermatitis solaris, and repel insects. Clinical trials for the two gels will last approximately six months, and management expects to receive final SFDA approvals in 2010.

Yan-Qing Liu, chairman and CEO of China Sky One Medical, said: We are very pleased to achieve such great progress in developing new drugs. All of these products have been developed to meet customers’ needs. We expect them to perform well and to create value for consumers and shareholders alike.