Lobaplatin for Injection(10mg)/(50mg)
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Hainan Changan International Pharmaceutical Co. Ltd.
Hainan Changan International Pharmaceutical Co., Ltd. (originally named Hainan Tianwang International Pharmaceutical Co., Ltd.), founded in August 19th, 1993, is specialized in the production and sale of pharmaceutical raw materials and preparations and, renamed Hainan Changan International Pharmaceutical Co., Ltd. in January 15th, 2003. Hainan Changan International Pharmaceutical Co., Ltd. is a national high-tech research and development plan (863 plan) project enterprise, national torch plan key high-tech enterprises, national Development and Reform Commission high-tech industrialization demonstration project enterprise, national innovative enterprises pilot units, national biochemical engineering technology research center of biological pharmaceutical industry base. Hainan Changan International Pharmaceutical Co., Ltd. is engaged in research and development, production and marketing of pharmaceutical raw materials and preparations with a registered capital of RMB 81.63 million. The present personnel is 125( of personnel with master degree or above: 2%, personnel with college degree or above: 35%, middle and senior technicians: 26 persons) and personnel in the corresponding type of work and the post office all have qualification certificate. The existing APIs(Lobaplatin), powder for injection, large capacity injection and lyophilized powder for injection of four production lines, all have passed national GMP certification. Since its establishment, the company enjoys a rapid development with continuously comprehensive strengths, enjoying good social reputation and winning many domestic and international honors. As a key high-tech enterprise of national torch plan, the company successively undertakes several technology projects, including three projects of the national torch plan projects, one project of the national high-tech industrialization demonstration projects of Development and Reform Commission, two projects of National New Products Program, one project of national “813” plan, two projects of key science and technology plan projects of Hainan province, 2 projects of key science and technology plan projects of Haikou City, etc. The national, provincial and municipal scientific research projects progress smoothly and have entered the industrialization of production, occupied more than 90% of the proportion in the total industrialoutput value. The company has been awarded a key national high-tech enterprise and the top 50 industrial enterprises in Hainan province for consecutive years. The company is located in the beautiful scenery of the Hainan Province, Haikou National Hi-tech Industrial Development Zone. Currently we mainly produce the following products: Lobaplatin and Lobaplatin for Injection (National Class I new drug, exclusive products), Fructose Sodium Diphosphate for Injection, etc. Fructose Sodium Diphosphate for Injection (" FoDi”: famous trademark in Hainan province ") enjoys the national market share to a certain extent. Sales of the exclusive Lobaplatin for Injection (National Class I new drug, global patent products) rise year by year since it is put into market, and this product has become the main product for company's main profit-growth point. In the process of company’s twenty-year development, the company has always been vigorously supported and cared by governments and leaders at all levels. Over the years, in the preferential policy environment of increasing support for high-tech industry development in Hainan province, it responses the national call and constantly sticks to product technological innovation as its guide, with the development strategy considering patent as its barrier, so as to maintain faster development speed and higher profit of the company in the fierce competition. The company believes in "Healthy life, Changan companies", and its mansion is to reduce human disease pain and improve people's quality of life. Service the state and repay the society.
Lobaplatin is the third generation of platinum antineoplastic drugs, originally researched by the German ASTA company. In 2003, Hainan Chang 'an International Pharmaceutical Co., Ltd. successfully transforms intellectual property rights of Lobaplatin to China, approved for marketing in China in 2005. Lobaplatin has alkylation and it is a generalized alkylating agent. It has definite cytotoxicity for a variety of animal and human tumor cell lines, and its pharmacological effects are similar to those of cis-platinum. Clinically, Lobaplatin for Injection mainly used in the treatment of breast cancer, small cell lung cancer and chronic myeloid leukemia.
The clinical administration features of Lobaplatin for Injection are as bellows:
1, Lactic acid platinum, water solubility, good stability;
2, Anticancer spectrum similar to cis-platinum, anticancer activity quiet similar to cis-platinum and more stronger than carboplatin, and no cross-resistance with other platinum drugs;
3, No obvious nephrotoxicity, ototoxicity and neural toxicity, and gastrointestinal tract toxicity is lighter;
4, Rapid clearance through the kidney, not easily be accumulated in the body, short duration of effect and less toxic side effects.
Lobaplatin is featured by its chemical structure, physical and chemical properties and pharmacokinetics, etc., and thus bears the advantage of "high efficiency, low toxicity and no cross-resistance". Those advantages are gradually validated and revealed in clinical practice.
Further research and development of the treatment in refractory ovarian cancer, malignant coelomic effusion chemotherapy, advanced esophageal cancer, HCC with TACE(Transhepatic Arterial Chem Otherapy and Embolization), etc., are urgently needed for clinical treatment, and they are also have important social and economic value.
Innovative original research of Germany ASTA Medica;
Hainan Changan International Pharmaceuticals Co., Ltd. successfully transforms the intellectual property rights of Lobaplatin to China in September 2003, obtained the exclusive patent : "Naropa platinum trihydrate and its preparation and application".(ZL94106670.3);
Approved the specification of 50mg by SFDA in September 2005 to put into the market(H20050308);
"Research and Development of Lobaplatin" awarded the project fund of the eleventh five-year plan and 863 plan in April 2007(Project number: 2006AA020608);
Approved the specification of 10mg by SFDA in March 2008 to put into the market. (H20050308);
Selected as national health care products in November 2009;
"Secondary Research and Development of Lobaplatin as a Class I Antineoplastic New Drug" obtained special project fund for science and technology major projects in Guizhou province in July 2011. [Project number: Guizhou branch and traditional Chinese medicine (TCM) word (2011)5068]
"Phase IV Clinical Trial of Lobaplatin as a Class I Antineoplastic New Drug" obtained a special project funding for essential innovative drug in science and technology in the state 12th five-year plan in September 2012(Project number: 2013ZX09014-001).