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CMS 024, with the common name of Tyroserleutide, is the lead
compound developed by CMS through 6 years' study and is hoped
to be the first tripeptide treatment for unresectable primary
liver carcinoma in the world. Through clinical trials, CMS 024
has been proved effective, safe and well-tolerated. In addition,
CMS 024 was granted "Orphan Drug" status by US FDA
and financially supported by the National "863" Program
and the 10th Five-year Plan.
During the period from October 2003 to April 2005, CMS 024 completed
Phase I, Phase IIa and Phase IIb clinical trials successively.
On 9 June 2005, CMS submitted new drug application to SFDA for
marketing approval. At present, CMS 024 has been through the
technical examination, and is waiting for final administrative
approval.
Results of clinical trials confirm that CMS 024 can significantly
suppress tumour growth and prolong patients' survival, with
mild side effects and toxicity. Therefore, there will be a large
potential market for CMS 024 in China.
With patent applications in the USA, Europe, Japan and some
other major countries, and "Orphan Drug" designation
by the US FDA, CMS expects to cooperate with other international
agencies to develop the global market of CMS 024 by out-licensing
its patent right. |
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