| 作者 |
 [分享]Tongjitang's Osteoperosis Drug Likely to Win FDA Approval |
 |
renjing
头衔: 海归上士
加入时间: 2005/04/12
文章: 12
海归分: 1690
|
|
|
作者：renjing 在 海归商务 发贴, 来自【海归网】 http://www.haiguinet.com
Tongjitang's Osteoperosis Drug Likely to Win FDA Approval
posted on: October 31, 2007
Tongjitang Pharmaceuticals announced its mainstay traditional Chinese medicine for osteoporosis, Xianling Gubao, was effective in a two-year trial.
The randomized, double-blind, multi-center study demonstrated that Xianling Gubao prevented bone resorption and increased bone density. The trial was conducted in patients with post-menopausal osteoporosis.
Bone resorption is the process by which osteoclasts break down bone and release the minerals, causing a transfer of calcium from bone fluid to the blood.
After six months of use, Xianling Gubao was found to inhibit bone resorption by 25% and increase the bone density of the spine (the lumbar vertebrae L1) by up to 3.1%. Without Xianling Gubao, the density loss in bone can be as much as 2%. Bone density in the hip was also maintained.
A secondary finding of the study was that calcium and vitamin D supplements do not by themselves improve bone density.
Tongjitang will use the data from the test, which was gathered entirely in China, as a basis for its request for FDA approval of Xianling Gubao in the US. Tongjitang began the trial in late 2005. At the time, the company expected to be granted FDA approval in 2006. Now, Tongjitang is budgeting more than $10 million and a time period of three to five years before the FDA makes a ruling.
The trial was conducted by Synarc, which is headquartered in the US, but with operations spread throughout the world, including Beijing. Synarc specializes in clinical trials that involve radiology and biochemical biomarkers.
It is noteworthy that Synarc co-founder, Chairman Emeritus and osteoporosis authority, Harry K. Genant, serves on Tongjitang’s board as an independent director.
FDA approval would open a huge market for Xianling Gubao, as the west would welcome a TCM drug for osteoporosis. At present, the drug is marketed only in China. In August, Xianling Gubao was given “Trade Secret Status” by China, guaranteeing Tongjitang marketing exclusivity for five years.
As a company, Tongjitang remains heavily dependent upon Xianling Gubao, which is sold as both a prescription and OTC drug. In China, the modernized formulation of a TCM compound is approved by the SFDA for osteoporosis, osteoarthritis, ischemic necrosis and bone fracture. It produced sales of 375 million RMB ($48 million) in 2006, an amount that comprised 77% of Tongjitang’s total revenues.
作者：renjing 在 海归商务 发贴, 来自【海归网】 http://www.haiguinet.com
|
|
|
| 返回顶端 |
|
 |
|
-
 [分享]Tongjitang's Osteoperosis Drug Likely to Win FDA Approval -- renjing - (2483 Byte) 2007-11-03 周六, 16:58 (1126 reads)
|
|
|
|
您不能在本论坛发表新主题, 不能回复主题, 不能编辑自己的文章, 不能删除自己的文章, 不能发表投票, 您 不可以 发表活动帖子在本论坛, 不能添加附件不能下载文件, |
|
|
