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Rng View

Domestic bisphosphonate drugs getting better - Bisphosphonates, drugs - the pharmaceutical industry

In the global clinical treatment of osteoporosis drugs, bisphosphonate drugs share reached 75%, but at home, bisphosphonate drugs market share of about 23% to 25% lower than the activity of calcium and vitamin D3 preparation 44% to 47%. In addition, calcitonin drugs and hormone replacement therapy drugs, also in the domestic treatment of osteoporosis drugs family place. In this issue, this edition will be followed by analysis of bisphosphonate drugs, calcitonin drugs and hormone replacement therapy drugs to market performance. Diphosphonic acid drugs in the last 20 years the rapid development of drug resistance to metabolic bone diseases, have become first-line treatment of osteoporosis therapy and the treatment of hypercalcemia of standard drugs. In accordance with the structure of side chain composition of view, the diphosphonic acid drugs have gone through three generations of products are now available from the earliest first-generation products?? Etidronate for the development of third generation?? Zoledronic acid salt and Eben alendronate. Foreign varieties have been matured for 10 clinical, have also launched a national research and development of such drugs, at present, etidronate, sodium chloride phosphine Qu, alendronate, pamidronate has been State issued a new drug certificate and production licenses, the product used in clinical treatment of the listing. National sample of hospitals from the major cities in the amount of view diphosphonic acid drugs, pamidronate about 40%, 28% of alendronate sodium, sodium chloride 19.5% QU phosphine, etidronate 12.7 %. The third generation of diphosphonic acids is still in the product development stage drugs. Extensive clinical application showed that bisphosphonates on bone metabolic diseases with better efficacy, but in physics, chemistry, biology and toxicology varies, now has introduced new varieties of its better efficacy and safety of , in addition to the above-mentioned species, the Sanofi-Aventis of tiludronate, Egypt, Boehringer Mannheim Corporation and the Japanese mountains of the Alendronate within the development of the British card approved bisphosphonates are marketed abroad.

It is understood that, from 2005 to 2010 Bisphosphonates anti-osteoporosis have three varieties in the U.S. patent expired, respectively, pamidronate (2005), Pyridostigmine disodium ( 2006), alendronate (2007), for domestic enterprises, research, and grasp this opportunity will be the key to training the relevant market. Pamidronate: a good trend Pamidronate inhibited bone resorption than chlorine 10 times stronger flexor alendronate, etidronate than 100 times, the original research and drug development by the Swiss company Ciba-Geigy, 1987, the brand name in Argentina Aminomux listed; in the UK in 1989, trade name Aredia (A up); in October 1991 received FDA approval for the treatment of malignant hypercalcemia complicated, Pei Jishi disease, osteolytic metastasis, and idiopathic osteoporosis. Pamidronate in the United States patent expires in July 2005 deadline, the current world-wide patent application was only more than 10 domestic-related patent application no. April 30, 1997, China has authorized Novartis pamidronate injection and the hydrate and administrative protection. 1996, Shanghai Medical Engineering Institute, Nanjing Institute of Pharmacology and Biomedical Engineering, Hefei were successfully developed, issued by the Ministry of Health drug pamidronate Type II certification. The small batch production and clinical trial study, in December 1998, Shenzhen Neptunus Pharmaceutical has made the country Yaozhun Zi (1998) X-446, X-447 symbol of raw materials and injection drugs, in March 1999 Zhejiang Aotuo Kang Pharmaceutical Group has made material and injection drug production licenses. 2006, SFDA has been examined and approved 13 domestic production of the species. In addition, pamidronate into China since 2000 muscle - bone drugs hospital sales of the top 10, currently in China market dominant inhibitor of bone resorption. Recent years, pamidronate in the country are strong, and among the best in the same species, occupying two-phosphonic acid drug market, the major share. 2005, the domestic pharmaceutical wholesale market area of pamidronate as 34.81 million yuan, a decline compared to last year. In clinic, many patients with advanced cancer bone metastasis, causing the solubility of bone destruction, while patients with multiple myeloma osteolytic rapidly, and therefore, "Ah up" is to improve the life of cancer patients One of the quality of drugs and promoted the progress of this market. In 1999, "A reach" of the global sales of 500 million U.S. dollars, an increase of 55.6% in 2000, surpasses the previous year by 34% to over 663.2 million U.S. dollars, in 2001 the sale of pamidronate results for the 752 million U.S. dollars, ranked the world best-selling drugs in the first 70. With pamidronate patent period draws near, new products Novartis zoledronic acid has quickly replaced its position, occupied the high-end market, a Novartis drug in this class backbone.

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