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China Sky One Medical (NSDQ: CSKI) announced its development-stage innovative cancer drug, Antroquinonol (Hocena) capsules, has been recognized as a Breakthrough Drug by China’s Ministry of Science and Technology (MoST). The designation qualifies Antroquinonol for accelerated approvals as well as financial and technical support of its development.

Because of the speeded-up approval process, China Sky One expects to begin human trials of Antroquinonol within a year and receive SFDA marketing approval of the drug within three years, an extremely short time-line for a cancer drug.

China Sky One acquired the China rights to Antroquinonol in May 2009 from Taiwan Golden Biotechnology Corporation. The compound is extracted from Antrodia Cinnamomea Chang & Chou, a medicinal fungus found inside a tree native to Taiwan, Cinnamonum kanehirae.

As a TCM, the drug has been used to eliminate toxins, protect the liver, improve the immune system, fight allergies, and reduce blood fat. Its use as a cancer treatment was not immediately apparent because the TCM dosage of the drug is too weak to be effective against cancer. Using a more sophisticated extraction technique, Golden Biotechnology isolated pure Antroquinonol, which it has patented in 60 countries.

In laboratory tests, the stronger version of Antroquinonol has been found effective against liver and lung cancer. The FDA has approved initial clinical trials of the drug in the US. China Sky One and Taiwan Golden Biotechnology are developing the drug jointly.

Antroquinonol is a departure for China Sky One, which produces a large portfolio of OTC products, many of them delivered topically. However, China Sky One is clearly interested in the sector, as it has two other patented cancer drugs in development with other entities.

The company points out that Antroquinonol capsules are the first product in Heilongjiang Province to be granted Breakthrough status.

MoST, together with the Ministry of Health, established the Breakthrough Drug program to encourage development of drugs that treat cancer, AIDS and cardio- and cerebro-vascular diseases.

Disclosure: none.

Source: China Sky One's Cancer Drug Wins 'Breakthrough' Status