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Guizhou Tongjitang Seeks FDA’s approval for XianLingGuBao
Guizhou
Tongjitang Pharmaceutical Company Limited (Tongjitang) has kicked
off the registration procedure with FDA for its core product “XianLingGuBao”. The company intended to invest US$10 million with
a view to bringing it to market in 3 to 5 years. Hopefully it will become a FDA-approved
Chinese medicine product launched into the
international market.
According
to the joint announcement by Synarc and the Tongjitang, XianLingGuBao can
effectively regulate the bone metabolism and raise bone density. Clinical tests demonstrate that it can
significantly inhibit bone resorption by upto 25% after 6 months of medication.
The test also indicated that treating postmenopausal
osteoporosis
with XianLingGuBao
for 6 months could increase the overall vertebral bone density
by 2.1%, 3.1% for the first vertebrate, and the density of hip bones remained
stable.
The research was conducted by local and overseas osteoporosis
experts for one year on large samples using a double-blind, randomized method of testing. Biochemical tests were carried out by a
biochemical research institute in France while all the biostatistics data were
compiled by University of California, indicating that the efficacy of Chinese
medicine in treating osteoporosis has been confirmed by international authorities. It was also the first evidence-based
clinical study on the efficacy and safety of traditional Chinese medicine
conducted according to international standard and FDA requirements with proven
results.
The major ingredients of Xianling Gubao include Yinyanghuo, Xuduan, Buguzhi,
Dihuang, Dansen and Zhimu. Total
sales in China has reached RMB500 million to date. With FDA recognition and the unique characteristics of
Chinese medicine, its future launch into the international market is expected
to be very promising.
Synarc is a world-leading research institute in medical
image-analysis, subject-recruitment, and biochemical marker. Its services
are currently used in more than 200 clinical trials around the world.
Sources: Ynet.com
Menet
Tianjin
Daily
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