China Sky One Adds Breast Lesion Drug to Product Portfolio

China Sky One Medical (CSKI) has bought a proprietary breast lesion drug from Harbin Medical University for 10 million RMB ($1.5 million). The drug, which China Sky One and Harbin developed jointly, has completed its Phase I trial. In the more than 10,000 patients enrolled in the test, the drug was 100% effective with an 89% curability rate.

China Sky One said that final SFDA approval for the drug is about two to three years in the future. The company estimates the drug will generate 1 billion RMB ($146 million) in revenue during its first five years of production.

The drug seeks to treat lobular hyperplasia, a type of mastitis that may lead to breast cancer. China Sky One put the potential China market for the drug at 36 million women in China, noting that the condition is a currently unmet need.

The majority of China Sky One’s portfolio is comprised of OTC products, many of them based on traditional Chinese Medicines. The breast lesion drug, therefore, represents a departure from its established business plan.

Disclosure: none.