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non-small cell lung cancerKanglaite Intellectual Properties

Kanglaite’s intellectual property is protected by issued patents and pending patent applications. This includes U.S. patents and applications as well as foreign counterparts in over 10 countries including China, the European Union (EU), Russia, Japan, Korea and Indonesia. Issued claims cover chemical component, process technology and methods of use. More information about specific IP matters can be obtained via the U.S. Patent & Trademark Office or by contacting Kanglaite-USA at info@kltusa.com.

Kanglaite Injection (KLTi)

KLTi is a sterile microemulsion for intravenous administration. The active pharmaceutical ingredient is a partially purified extract from coix seeds (Coix lacryma-jobi, family Cramineae), and as such is considered a botanical drug product under U.S. Food & Drug Administration (FDA) regulations (ref FDA Guidance for Industry, Botanical Drug Products, June, 2004).

The plant has a history of use in traditional Chinese medicine, including use as an anti-inflammatory agent. As a botanical drug, KLTi is approved in China for treatment of patients with advanced non-small cell lung cancer (NSCLC) and advanced hepatocellular cancer. KLTi is also approved in Russia for treatment of patients with advanced NSCLC.

The extract employed in KLTi was developed by Dr. Dapeng Li, M.D., Ph.D., the founder of Zhejiang Kanglaite Group Co. Preclinical and clinical research conducted in China with this extract has shown an anti-tumor effect, as well as mitigation of weight loss and other symptoms of cachexia and anorexia in cancer patients.

KangLaiTe USA has completed a phase II clinical trial for KLTi in advanced pancreatic cancer patients in the US in 2014 with very promising data. The study was conducted under Investigational New Drug Application 113,855.

Kanglaite Gel Cap (KLTc)

KangLaiTe USA has also completed a phase II clinical trial for the oral dose form Kanglaite soft gel cap (KLTc) in prostate cancer patients in the US. The study was conducted under Investigational New Drug Application 110,502 and data from the study are being analyzed at the moment. Originally approved in China in 2003 for the treatment of patients with advanced non-small cell lung cancer, KLTc is used today in that country primarily in palliative care of patients with advanced cancer.

The investigational product is a gelatin capsule containing purified coix seed oil, the active pharmaceutical ingredient of the injectable product. It is provided as a translucent yellow gelatin capsule.