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China Medical Announces the Receipt of SFDA Approval for Two of its FISH Probes
Jan 22, 09 01:00AM
China Medical Technologies Announces the Receipt of SFDA Approval for Two of its FISH Probes and the Approval for the Hi-Tech Enterprise Status for its PRC Subsidiaries
BEIJING, Jan. 22 /PRNewswire-Asia-FirstCall/ -- China Medical Technologies, Inc. (the "Company") (Nasdaq: CMED), a leading China-based medical device company that develops, manufactures and markets advanced in-vitro diagnostic products, today announced that the Company has received approval for its Prenatal FISH Probe and Cervical Cancer FISH Probe from the State Food and Drug Administration (the "SFDA") in the People's Republic of China (the "PRC").
The Prenatal FISH Probe is a detection kit for the analysis of trisomies 13, 18 and 21 and sex chromosome aneusomies (X and Y). Prenatal screening of trisomy 21 (Down Syndrome) is becoming more prevalent in China and the Prenatal FISH Probe can provide a quicker and more efficient confirmative approach to the prenatal screening results. The Cervical Cancer FISH Probe is designed to detect the amplification of the TERC gene in human cervical tissue, which has been demonstrated to be associated with the severity of cervical disorders. Detection of the TERC amplification as a biomarker can provide better assessments of cervical disorders for clinical diagnosis.
The Company's PRC subsidiaries have received approval for the hi-tech enterprise status from Beijing government authorities. With this status, the subsidiaries are entitled to a preferential income tax rate of 15% which is lower than the statutory income tax rate of 25%. The status is valid for three years and will be renewed after evaluation by relevant government authorities every three years.
"We are pleased to receive SFDA approval for two of our FISH probes and achieve the hi-tech enterprise status under new stringent criteria," said Mr. Xiaodong Wu, Chairman and CEO of the Company. "With the SFDA approval, our hospital customers in different provinces can apply for the inclusion of the two FISH Probes in the reimbursement menu of respective provincial medical insurance programs which we believe will result in increased usage of the probes in the future. The hi-tech enterprise status demonstrates the government's recognition of our achievements in developing and manufacturing advanced innovative products. Furthermore, the PRC government announced yesterday that an estimated amount of RMB850 billion will be spent in the next three years on healthcare reform initiatives, with a significant portion in medical insurance programs. We believe the IVD industry in China will strongly benefit from these initiatives. As such, we have strong confidence in the Company's future prospects despite the challenging market environment."
About China Medical Technologies, Inc.
China Medical Technologies is a leading China-based medical device company that develops, manufactures and markets advanced in-vitro diagnostic (IVD) products using Enhanced Chemiluminescence (ECLIA) technology, Fluorescent in situ Hybridization (FISH) technology and Surface Plasmon Resonance (SPR) technology to detect and monitor various diseases and disorders. For more information, please visit http://www.chinameditech.com .
Safe Harbor Statement
This press release contains forward-looking statements. These statements constitute "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar statements. Such statements involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Further information regarding these and other risks is included in the Company's filings with the U.S. Securities and Exchange Commission, including its annual report on Form 20-F. The Company does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law.