China

Kanglaite Injection represents the successful realization of one scientist's vision. Trained in both western pharmacology and traditional Chinese medicine, Dr. Dapeng Li identified and isolated the active pharmaceutical ingredient from a well-respected traditional remedy. Under his direction, the drug substance was then developed into a western-style pharmaceutical and successfully marketed in China and Russia.

Dr Li’s isolate, an extract of the coix seed, was demonstrated to limit growth of implanted tumors in several xenograft models. A microemulsion of this extract suitable for intravenous use was also developed, and was found to be associated with both tumor regression and symptomatic relief in cancer patients. Zhejiang Kanglaite Group obtained authorization from the Chinese Ministry of Health to market the emulsion in 1997. The approved indications in China are: treatment of patients with advanced non-small cell lung cancer (NSCLC) or hepatocellular carcinoma, either alone or as an adjunct to chemotherapy or radiation therapy, and palliation of patients with advanced cancer of any type. Zhejiang Kanglaite Group likewise developed and obtained regulatory approval in China for an oral version of the proprietary extract in a gelcap form that may provide a second generation product in the US. In 2003 Zhejiang Kanglaite Group obtained marketing authorization for Kanglaite Injection in Russia.

In 2005, Zhejiang Kanglaite Group integrated an improved extraction process for the botanical raw material into its production procedures, and opened a modern drug substance (active pharmaceutical ingredient; API) extraction and purification facility near Hangzhou. The API facility provides drug substance to an equally modern drug product facility for manufacture of the finished pharmaceutical product. Both the API facility and the accompanying drug product manufacturing facilities are designed based on US and European models. Modern processing equipment was largely obtained from and installed and validated by European and US suppliers.

United States

In 2001, a US subsidiary of Zhejiang Kanglaite Group was established in Salt Lake City. Under a US IND, a rising-dose pharmacokinetics and safety study in sixteen (16) patients with advanced solid tumors was conducted at the Huntsman Cancer Institute. Results of the study were presented at the American Society for Clinical Oncology (ASCO) conference in 2003. The US patients were given daily doses of Kanglaite Injection ranging from 50 to 250% of the usual dose administered in China. Dosing cycles (21 days of treatment with 7 days between treatment) were repeated up to six consecutive times without reaching a maximum tolerated dose.

The US subsidiary, KangLaiTe USA, relocated to the San Francisco Bay area in 2007.  Phase 2 studies in non-small lung cancer, pancreatic cancer, cancer-associated cachexia anorexia syndrome, and prostate cancer are planned.