Milestones:
2014: KangLaiTe-USA completed its phase II clinical study in pancreatic cancer patients in the US and an end of phase II meeting was held with FDA in November. A phase III study in pancreatic cancer patients was proposed to FDA at the meeting.
2013: Interim results from KangLaiTe-USA’s Phase II pancreatic cancer study were published in conjunction with the American Society of Clinical Oncology annual meeting in May: www.ASCO.org and www.JCO.org.
2012: Interim results from KangLaiTe-USA’s Phase II pancreatic cancer trial showed improved progression free and overall survival for patients receiving Kanglaite Injection (KLTi) plus gemcitabine. KangLaiTe-USA presented trial results at the Multinational Association of Supportive Care in Cancer Annual Conference in Boston on June 28, 2012.
2011: KangLaiTe-USA initiated a Phase II prostate cancer study for Kanglaite Gel Caps (KLTc) in the U.S.
2011: KangLaiTe concluded its Phase II pancreatic cancer study for KLTi in China and published the results in conjunction with the American Society of Clinical Oncology annual meeting and the Journal of Clinical Oncology.
2008: KangLaiTe-USA initiated a Phase II Pancreatic Cancer study for KLTi in the U.S.
2007: Dr. Edward Gabrielson at the Johns Hopkins University and Dr. Dapeng Li of KangLaiTe published a paper in Cancer Biology & Therapy describing the mechanism of action of KLTi.
2006: KangLaiTe initiated a Phase II pancreatic cancer trial for KLTi in China to compare KLTi plus gemcitabine with gemcitabine alone.
2003: KangLaiTe presented results of the Phase I study for KLTi at the American Society for Clinical Oncology.
KangLaiTe obtained marketing authorization for KLTi in Russia and the Russian Ministry of Health issued a registration certificate in December.
KangLaiTe-USA conducted its Phase I safety study for KLTi at the Huntsman Cancer Institute at the University of Utah.
KangLaiTe obtained marketing authorization for KLTi in Russia and the Russian Ministry of Health issued a registration certificate in December.
KangLaiTe-USA conducted its Phase I safety study for KLTi at the Huntsman Cancer Institute at the University of Utah.
2002: KangLaiTe opened a modern drug substance extraction and purification facility near Hangzhou, China.
2001: The U.S. Food and Drug Administration approved KLTi the initiation of clinical study in the U.S.
2001: Kanglaite Gel Capsule (KLTc), an oral version of the proprietary extract, obtained regulatory approval in China.
2000: Zhejiang Kanglaite Group Co., Ltd. established a U.S. subsidiary called KangLaiTe-USA.
1995: The Hangzhou Kanglaite Industrial Co., Ltd was renamed Zhejiang Kanglaite Pharmaceutical Co., Ltd. The Chinese Ministry of Health approved KLTi for the treatment of patients with non-small cell lung cancer and primary hepatic cancer.
1993: Dr. Dapeng Li established Hangzhou Kanglaite Industrial Co., Ltd. in China.
1985-1992: Dr. Dapeng Li, renowned Chinese pharmacologist, identified and isolated the active pharmaceutical ingredient in coix seed, and eventually developed it into an intravenous medicine he called Kanglaite Injection (KLTi), which is associated with tumor regression and symptomatic relief in cancer patients.