Phase IV Multi-center Clinical Study Of Kutai Concludes In Nanjing

Main Category: Pain / Anesthetics
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 25 Mar 2009 - 2:00 PDT

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Sinobiopharma, Inc. (OTC Bulletin Board: SNBP) is pleased to announce that its patented version of Cisatracurium besylate, a pre-surgical skeletal muscle relaxant marketed as Kutai in China, has successfully concluded its Phase IV Clinical Study.

The multi-center Phase IV Clinical Study investigated the safety and effectiveness of Kutai's use at room temperature. The after-market study, supported by the National Multi-center Clinical plan, was concluded successfully on September 2, 2008.

Kutai is a non-depolarizing skeletal muscle relaxant for intravenous administration. Compared to other neuromuscular blocking agents, it is intermediate in its onset and duration of action.

More than 30 clinical experts from seven participating medical centers within China gathered in Nanjing for a conference to review the results of the Phase IV of the Kutai Multi-center clinical study project.

Ms. Xinming Wu, Chief anesthetist of No.1 Hospital of Chinese Peking University Anesthesia Department, presided over the conference and delivered a summary report of the Phase IV project. Xuejun Chen, Sinobiopharma's vice president of sales was also in attendance and expressed Sinobiopharma's thanks to the participating experts for their commitment to research on Kutai.

Sinobiopharma has established a highly specialized professional team of clinical trial monitors as part of the project to keep close surveillance on the patients. The manager of Sinobiopharma's Clinical Research Department, Mr. Lei Wang, reported on the Phase IV project clinical monitoring outcomes.

The experts' consensus was that the Phase IV study established Kutai as safe and effective for room temperature storage. The year-long clinical research project showed no significant differences between Kutai and imported Cisatracurium besylate, and no significant differences for Kutai safety and effectiveness when stored at either room temperature or a lower temperature.

All the participating parties followed the study design and promote inter-communication to ensure compliance with Good Clinical Practice (GCP).

About Sinobiopharma

Sinobiopharma, Inc. is a fully integrated and highly innovative biotechnology company engaged in the research and development, manufacture and marketing of biopharmaceutical products in China, the world's fastest growing pharmaceutical market. Known as Dong Ying (Jiangsu) Pharmaceutical Co. Ltd. in China, the Company's current therapeutic focus is on anesthesia-assisted agents and cardiovascular drugs.

FORWARD LOOKING STATEMENTS

This news release may include "forward-looking statements" regarding Sinobiopharma, Inc., and its subsidiaries, business and project plans. Such forward looking statements are within the meaning of Section 27A of the Securities Act of 1933, as amended, and section 21E of the United States Securities and Exchange Act of 1934, as amended, and are intended to be covered by the safe harbor created by such sections. Where Sinobiopharma, Inc. expresses or implies an expectation or belief as to future events or results, such expectation or belief is believed to have a reasonable basis. However, forward-looking statements are subject to risks, uncertainties and other factors, which could cause actual results to differ materially from future results expressed, projected or implied by such forward-looking statements. Sinobiopharma, Inc. does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

Sinobiopharma, Inc.
http://www.sinobiopharma.com

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