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The National Institute for the Control of Pharmaceutical and Biological Products has reported that the Company's flawed rabies vaccines contained nucleic acid, which as a prescription drug has been legally produced by more than twenty manufacturers in China and widely used in the Chinese market. However, it has not yet been approved as an ingredient to be added in human rabies vaccine in China. Although tests on animals demonstrated that the nucleic acid did enhance the effectiveness of the human rabies vaccine, it had to undergo clinical trials before it could be used as an adjuvant in human rabies vaccines. Dalian JGAD was found falling afoul of such regulatory rules. Among 360,200 doses of the flawed rabies vaccines in China, a total of 323,200 have been recovered by the manufacturer, Dalian JGAD. The rest of the rabies vaccines were not used and had been held for recall. To date, there has been no report of vaccine related illness received by Chinese National Center for Adverse Drug Reaction Monitoring.
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Furthermore, the China State Food and Drug Administration ("SFDA") has confiscated all the flawed products and profits from the sales of the flawed rabies vaccines. The SFDA will also assess a punitive fine of 145 Million Chinese Yuan. Dalian JGAD has been suspended from production and sales of vaccines since the recall. The production permit of Dalian JGAD was also revoked. Additionally, the key officers involved have been forbidden from engaging in any production activities within the pharmaceutical industry for a period of ten years. Two senior executives and one purchasing agent of Dalian JGAD have been detained by local authorities.
Safe Harbor Statement
The Statements contained in this press release are being made on the basis of the Company's review of the situation to date. Furthermore, the information contained herein may change as the governmental investigation is ongoing. Additionally, statements made in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties that may cause actual results to differ materially from those set forth in these statements. The economic, competitive, governmental, technological and other factors identified in the Company's previous filings with the Securities and Exchange Commission may cause actual results or events to differ materially from those described in the forward looking statements in this press release.
SOURCE China Bio-Immunity Corporation
