KangLaiTe USA is a privately held biotechnology company developing a treatment for solid tumor cancers and for cancer-associated anorexia-cachexia syndrome (CACS). The company has US$25MM in funding from its parent company, Zhejiang Kanglaite Group Ltd.

The lead product under development, Kanglaite Injection, was approved by the Chinese Ministry of Health for the treatment of patients with advanced non-small cell lung cancer (NSCLC) and hepatocellular cancer in 1997 and in Russia for treatment of patients with advanced NSCLC in 2003.

Kanglaite Injection is a  sterile microemulsion for intravenous administration. The active pharmaceutical ingredient is a partially purified extract from coix seeds (Coix lacryma-jobi), and as such is considered a botanical drug product under US FDA regulations (ref FDA Guidance for Industry, Botanical Drug Products, June, 2004 http://www.fda.gov/cder/guidance/4592fnl.pdf). KangLaiTe USA holds an exclusive, royalty-free license to the product for all markets in the Americas.

The company holds an open IND for the drug with the US FDA for all indications related to treatment of cancer. A Phase 1 PK/dosing study has been completed under this IND. Principal investigators have been selected and protocols under the current IND are being finalized for Phase 2 clinical studies in NSCLC, pancreatic cancer, and CACS

The company is collaborating with researchers at Johns Hopkins University to investigate the efficacy and mechanism of action of the product in animal and in vitro models. Data from these studies have confirmed that Kanglaite Injection has a cytostatic effect on tumor cells and interferes with specific biochemical pathways previously shown to be involved in the development of various types of cancer.

KangLaiTe USA is located in Alameda, California, close to Oakland International Airport.