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Agenix set to file clinical trial application for Hepatitis B drug in China

Last updated: 04:00 27 Mar 2013 GMT, First published: 03:00 27 Mar 2013 GMT

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Agenix (ASX: AGX) has reaffirmed it is on track to file a clinical trial application for its proprietary Hepatitis B drug candidate, AGX-1009, with China's State Food and Drug Administration (SFDA).

The company said in its recent half yearly report that filing of the clinical trial application is now scheduled for the June quarter of 2013.

Agenix is planning to undertake clinical trials in patients with chronic hepatitis B who develop resistance to current approved therapies.

The company Agenix is working closely with its strategic partners in China via a joint Australian-China drug development model that will enable it to do the trials with much lower study costs and faster patient recruitment than is possible in developed markets.

Agenix and partner Institute of Medicinal Biotechnology (IMB) of the Chinese Academy of Medical Sciences are confident the clinical trial application will meet SFDA requirements.

China is forecast to become the second largest pharmaceutical market in coming years.

AGX-1009 is based on a proven active compound successfully used in Gilead’s Viread which is widely used in Europe and the U.S.

The drug will be positioned as a low-cost, once-a-day therapy for millions of chronic hepatitis B patients in China.

AGX-1009 is patented at a chemical level in China to 2026 and international patent applications have been filed for its method of manufacture.

China has plans to support the development of innovative new drugs like AGX-1009 by spending US$1 trillion on healthcare in 2020.

Some generic drugs will be given priority in the approval process, particularly drugs that are in short supply, lack a branded competitor or that are used to treat rare diseases.

The recently announced plan allows producers of new drugs to provide a draft version of their application when applying for registration and called for drug specifications to be clarified during the period between registration and mass production.

Agenix plans to advance AGX-1009 into phase one trials in the first half of 2014.


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