China Biopharmaceuticals Holdings, Inc., a leading Chinese pharmaceutical company focused on the development, manufacturing and marketing of innovative drugs in China, announced the completion of all required clinical trials for Desloratadine tablets for seasonal allergic rhinitis, also known as hay fever.
The trials were conducted in six hospitals throughout China. The trial results have been sent to the Chinese State Food and Drug Administration (SFDA) for manufacturing and marketing approval. The Company anticipates an approval response from the SFDA in the second half of 2007.
Desloratadine is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis. It is also indicated for the symptomatic relief of pruritus and the reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria. In China, 30% of the population has suffered from an allergy at least once. The $1.5 billion allergy drug market in China continues to grow at a rate of 15% per year.
CHBP President and Chief Operating Officer Lufan An said, "We are pleased to have completed all the required clinical trials for Desloratadine for the SFDA's review. We hope to have the SFDA's approval to manufacture and market this drug by the end of 2007. If we are granted production approval, CHBP will be one of only four pharmaceutical companies producing Desloratadine tablets in China through 2010. This is the latest accomplishment of our R&D team which has submitted 15 drug applications to the SFDA during this calendar year."
China Biopharmaceuticals Holdings, Inc (CHBP) is a research driven pharmaceutical company dedicated to the discovery, development, manufacturing and marketing of small and large molecule pharmaceutical products, including medicines, vaccines, and active pharmaceutical ingredients for various categories of diseases.
CHBP's product portfolio includes 260 drugs already approved for manufacturing and marketing by the Chinese State Food and Drug Administration (SFDA). CHBP also has submitted 15 drug applications to the SFDA for its review during the calendar year of 2006. CHBP is a U.S.-listed public company with operating subsidiaries and senior management based in China.
Source:佚名