BEIJING, Nov. 21 /PRNewswire-FirstCall/ -- China Biopharmaceuticals Holdings, Inc. , a leading Chinese pharmaceutical company focused on the development, manufacturing and marketing of innovative drugs in China, today announced the initiation of clinical trials to evaluate the safety and efficacy of Sofalcone for the treatment of digestive ulcers. CHBP is one of only three companies approved by the Chinese State Food and Drug Administration (SFDA) to conduct clinical trials for this drug in China. The trials will be conducted in six hospitals throughout China and are expected to be completed within one year.
Sofalcone is a mucoprotective agent with anti-Helicobacter pylori (H. pylori) activity, indicated for digestive ulcer and gastroenteritis. In preclinical tests, Sofalcone has produced a significant reduction in ulcer size as well as a substantial reduction in the number of H. pylori colonies in H. pylori-infected gnotobiotic mice. The market size of anti-ulcer drugs in China is approximately 12 billion RMB Yuan (or US$1.5 billion), increasing by 10% per year.
CHBP President and Chief Operating Officer Lufan An, stated, “We are pleased to have the authorization from the SFDA to initiate the clinical trials for Sofalcone. This authorization further demonstrates our R&D capabilities and our team’s proven ability to navigate the drug testing and approval process in China. We are excited about the candidates in our product pipeline.”
In a separate release, CHBP also announced today that it has completed and submitted all required trial results for Desloratadine tablets for seasonal allergic rhinitis, also known as hay fever, to the SFDA for manufacturing and marketing approval. CHBP also stated that it anticipates an approval response from the SFDA in the second half of 2007.
About China Biopharmaceuticals Holdings
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. For further information, please visit our website at http://www.cbioinc.com.
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CONTACT: Chris Peng Mao, CEO 86-10-8525-1616 info@cbioinc.com Julie Huang, Financial Dynamics 212-850-5628 chbp@fd.com
China Biopharmaceuticals Holdings, Inc.
CONTACT: Chris Peng Mao, CEO, +86-10-8525-1616, info@cbioinc.com; or JulieHuang of Financial Dynamics, +1-212-850-5628, chbp@fd.com
Web site: http://www.cbioinc.com/
