Zhejiang Kanglaite pharmaceutical co., ltd. is a subsidiary company of Zhejiang Kanglaite Group, established in 1995. It is not only designated as high-tech enterprise that is situated outside the high-tech developing zone in Zhejiang province by Zhejiang Scientific Committee, but also a “National Key High-tech Enterprise” chosen by the State Science and Technology Committee. It has been continuously honored as an excellent industrial and commercial enterprise in Zhejiang province for 3 years. Kanglaite is listed at the mainstay industry enterprise in Zhejiang province and Hangzhou city, nominated as “Charitable Enterprise” by Hangzhou Municipal Government, and “Credit AAA Grade” chosen by industrial and Commercial Bank Hangzhou Branch. The general economic benefit is among the best of the same line in Zhejiang and industrial enterprise in Hangzhou, and listed at “the Honor Roll of a Big Taxpayer (a wealthy and influential Taxpayer)” in Zhejiang province.
In 1998, the enterprise has invested 200 million yuan in building a top-ranking modernized fund of Traditional Chinese Medicine production in Hangzhou Xiasha Developing Zone (national level), now is in possession of a emulsion product line and a soft capsule product line which have passed the GMP authentication of SFDA. Currently, there are over five hundred staffs, among whom over fifty persons are in the management level, and 78 percent specialized technicians graduated from college and several Doctors and Masters of pharmaceutics. The administration has established 10 departments, 3 workshop and more than 30 representative offices all over the country. The purpose of enterprise is: “developing Chinese traditional medicines and promote national pharmaceutical industry, devoting oneself to the cause of human health”; “helping the mass people and salvaging their tribulations” and “obtaining from society, devoting ourselves to society”. The enterprise's heading patent product “Kanglaite Injection”, a novel double-effectible broad-spectrum anti-cancerous agent, is produced from the natural and effective active substance which is extracted from traditional Chinese medicine through the world advanced extracting methods. As a new-type emulsion both for intravenous and intra-arterial infusion, it can not only effectively kill cancer cells and prevent cancer sells from transferring, but also remarkably improve the overall immunity of the human body and protect the normal cells. The clinical experiment confirms that it has the significant therapeutic effect on lung cancer, liver cancer, colon cancer, gastric cancer, malignant lymphoma and leukemia, esophageal carcinoma, pancreatic cancer. Its curative effect is similar to that of chemotherapeutic agents. Combined with chemotherapy and radiotherapy, it has the remarkable synergistic and additive effect and reducing toxicity effect. In addition, it can provide high-energy nutrition, and relieve the pain. Up to now, Kanglaite Injection is still an ideal oncology clinical comprehensive drug both at home and abroad. It has been used in over 3000 large and medium hospitals at home and abroad, and has successfully applied to over 300,000 cancer patients, markedly improved patients' living quality and extended survival time, part of patients was cured. KLT study project was successively listed at “Grade A Project” by the State New-Medicine Research and Development Fund, “Torch Program” by the Science and Technology Department (originally State Science Commission), “Double-Quickening Project” by the State Economic and Trade Committee, “Key Project” in the Seventh Five-year Plan, the Eighth Five-year Plan and the Ninth Five-year supported by the Ministry of Public Health and the State Administration for Traditional Chinese Medicine. Kanglaite Injection was the first permitted production for intravenous and intra-arterial infusion since the new drug evaluation system was applied in 1985, and was the State New Medicine Type Ⅱ, the first time successfully developed in the history of Zhejiang province. KLT was successively listed at “State Basic Drug”, “State Basic Medical Safety Drug Product”, “State Key New Product”, “State Protected Traditional Chinese Medicinal Product”. Kanglaite Injection is a hi-tech product with intellectual property exclusively owned by China, has applied for patent in many countries, and obtained the patent certificates in China, USA, Russia, EC, Japan, Korea and South-Eastern Asia. Many famous experts of pharmaceutical circle offered the high praises to the successful project. Kanglaite Injection has won “the Second Prize of the State Scientific and Technological Progress” by the State Department, “the First Prize of the Scientific and Technological Progress” by the State Administration for Traditional Chinese Medicine, “the Third Prize of the State Technological Creation” by the State Science and Technology Ministry, “the Second Prize of the State New Medicine Creation” by the State Administration for Medicine. And it has won the first prize of State Science Commission and China Patent Office for many times; also it has been listed at a “A key Promotion Project of the State Scientific Achievement in the Ninth Five-year Plan” by State Science Commission, “Promotion Project of the Scientific Achievement in the Traditional Chinese Medicine” by the State Administration for Traditional Chinese Medicine. Today, the enterprise is performing the Secondary Development. On March 9 2001, FDA of the United States formally approved the IND application of Kanglaite injection. It marked a major breakthrough made by our country, thereby the Traditional Chinese Medicine, as a prescription drug, will conduct its clinical trial in the United States. We have made a substantial first step towards the world and won honor for our motherland and TCM. Up to now, the phase Ⅰ clinical study of KLT in USA came to an end as scheduled and achieved good efficacy as expected, thanks to these, the phase Ⅲ study will be conducted directly in the near future. On January 28 2002, the Health Ministry of Russian Federation formally approved the clinical trial of KLT injection in Russia. The clinical observation of all the cases have been completed with obvious curative effects, the results of the study have been affirmed by the Pharmacology Committee of Russia. The Health Ministry of Russia has issued a drug registration certificate to KLT injection, and Kanglaite has come into the market formally in Russia.