BEIJING, April 21 /PRNewswire-Asia-FirstCall/ -- Lotus Pharmaceuticals, Inc. (OTC Bulletin Board: LTUS) ("Lotus" or the "Company"), a growing developer, manufacturer and seller of medicine and drugs in the People's Republic of China (the "PRC") reported that its asthma drug Laevo-Bambutero will receive the China's State Food & Drug Administration's (SFDA) Fast Track Approval to enter clinical trials. The SFDA's Drug Review and Evaluation Center told the Company during recent consultations at the end of the Company's IND (Investigative New Drug Application) that formal approval would be granted by the Beijing office of the SFDA.
Laevo-Bambutero has completed the SFDA special review process under Category Two of the four categories of drugs that can receive speedier approval for IND, clinical trials and new drug production. SFDA issues special review and fast-track approval procedures for new drugs in 2009, under the following four categories of drugs:
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.
CEO, Dr. Zhongyi Liu, commented, "Millions of people are suffering from asthma 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 rights until 2022. We believe it is highly effective and has few side effects. We hope to accelerate the new tablet introduction to market and commercialization."
China's pharmaceutical industry has undergone the transformation from a generic-dominated model to the one that promotes drug innovation. The SFDA's Amended Measures effective in October of 2007 are intended to increase drug safety, tighten appraisal and approval processes while encouraging innovation. Given the SFDA's strict implementation of the Amended Measures, the Company believes that product pipeline pending SFDA approval status should only include Isosorbide Mononitrate-Sustained Release Tablets for cardiovascular disease, Gliclazide-Controlled Release Tablets for Type 2 diabetes and Laevo-Bambutero for asthma.
About Lotus Pharmaceuticals, Inc. (http://www.lotuspharma.com )
Lotus Pharmaceuticals, Inc. is a growing developer and producer of drugs and a licensed national seller of pharmaceutical items in the PRC. Lotus operates its business through its two controlled entities: Liang Fang Pharmaceutical, Ltd. and En Ze Jia Shi Pharmaceutical, Ltd. Lotus' current drug development is focused on the treatment of cerebro-cardiovascular disease, asthma, and diabetes. Liang Fang sells drugs directly and indirectly through its national sales channels to hospitals, clinics and drugs stores in 30 provinces of the PRC.
Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of the "safe-harbor" provisions of the Private Securities Litigation Reform 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 of similar meaning. Such statements are not guarantees of future performance and could cause the actual results of the Company to differ materially from the results expressed or implied by such statements, including, but not limited to, changes from anticipated levels of sales, future national or regional economic and competitive and regulatory conditions, changes in relationships with customers, access to capital, increased costs, difficulties in developing and marketing new products, marketing existing products, customer acceptance of existing and new products, the time to get new drugs approved by the State Food and Drug Administration and other factors. Additional information regarding risks can be found in the Company's Annual Report on Form 10K and its other filings with the SEC. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company has no obligation to update the forward-looking information contained in this press release.
For more information, please contact:
Lotus Pharmaceuticals, Inc.
Yan ZENG, CFO
Tel: +86-10-6389-9868
Email: zy@lotuspharma.com
