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» 23/07/2009 [Company watch]
China Aoxing Pharmaceutical Corp. Receives Renewal of GMP Certification for Capsule Dosage Form of Pharmaceutical Products
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»21/04/2010 [Company watch]
Lotus Pharmaceuticals\' Innovative Drug to Receive SFDA Fast Track Approval

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.

 

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;

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.


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