BEIJING, April 20 Lotus Pharmaceuticals,Inc. (OTC Bulletin Board: LTUS) ("Lotus" or the "Company"), a growingdeveloper, manufacturer and seller of medicine and drugs in the People'sRepublic of China (the "PRC") reported that its asthma drug Laevo-Bambuterowill receive the China's State Food & Drug Administration's (SFDA) Fast TrackApproval to enter clinical trials. The SFDA's Drug Review and EvaluationCenter told the Company during recent consultations at the end of theCompany's IND (Investigative New Drug Application) that formal approval wouldbe granted by the Beijing office of the SFDA.
Laevo-Bambutero has completed the SFDA special review process underCategory Two of the four categories of drugs that can receive speedierapproval for IND, clinical trials and new drug production. SFDA issues specialreview and fast-track approval procedures for new drugs in 2009, under thefollowing four categories of drugs:
CEO, Dr. Zhongyi Liu, commented, "Millions of people are suffering fromasthma worldwide, and 30-40 millions of asthma patients are estimated in China.It took ten years to develop Laevo-Bambutero, and we own its patent rightsuntil 2022. We believe it is highly effective and has few side effects. Wehope to accelerate the new tablet introduction to market andcommercialization."
China's pharmaceutical industry has undergone the transformation from ageneric-dominated model to the one that promotes drug innovation. The SFDA'sAmended Measures effective in October of 2007 are intended to increase drugsafety, tighten appraisal and approval processes while encouraging innovation.Given the SFDA's strict implementation of the Amended Measures, the Companybelieves that product pipeline pending SFDA approval status should onlyinclude Isosorbide Mononitrate-Sustained Release Tablets for cardiovasculardisease, Gliclazide-Controlled Release Tablets for Type 2 diabetes andLaevo-Bambutero for asthma.
About Lotus Pharmaceuticals, Inc. (http://www.lotuspharma.com )
Lotus Pharmaceuticals, Inc. is a growing developer and producer of drugsand a licensed national seller of pharmaceutical items in the PRC. Lotusoperates its business through its two controlled entities: Liang FangPharmaceutical, Ltd. and En Ze Jia Shi Pharmaceutical, Ltd. Lotus' currentdrug development is focused on the treatment of cerebro-cardiovascular disease,asthma, and diabetes. Liang Fang sells drugs directly and indirectly throughits national sales channels to hospitals, clinics and drugs stores in 30provinces of the PRC.
Safe Harbor Statement
This press release contains "forward-looking statements" within themeaning of the "safe-harbor" provisions of the Private Securities LitigationReform Act of 1995. Forward-looking statements include, without limitation,any statement that may predict, forecast, indicate, or imply future results,performance or achievements, and may contain the words "estimate," "project,""intent," "forecast," "anticipate," "plan," "planning," "expect," "believe,""will likely," "should," "could," "would," "may," or words or expressions ofsimilar meaning. Such statements are not guarantees of future performance andcould cause the actual results of the Company to differ materially from theresults expressed or implied by such statements, including, but not limited to,changes from anticipated levels of sales, future national or regional economicand competitive and regulatory conditions, changes in relationships withcustomers, access to capital, increased costs, difficulties in developing andmarketing new products, marketing existing products, customer acceptance ofexisting and new products, the time to get new drugs approved by the StateFood and Drug Administration and other factors. Additional informationregarding risks can be found in the Company's Annual Report on Form 10K andits other filings with the SEC. Accordingly, although the Company believesthat the expectations reflected in such forward-looking statements arereasonable, there can be no assurance that such expectations will prove to becorrect. The Company has no obligation to update the forward-lookinginformation contained in this press release.1) New active pharmaceutical ingredients (APIs) extracted from plants, animals or minerals, and newly discovered traditional Chinese medicines (TCM), along with their preparations, and products that are not sold in the domestic market; 2) Drugs, and their APIs, preparations, and biological products, have not been approved in the domestic and overseas market; 3) New drugs with superior efficacy for AIDS, malignant tumors and other rare diseases; and 4) New drugs for diseases for which there is no existing effective treatment.
SOURCE Lotus Pharmaceuticals, Inc.