I put together information out of a CC and the latest 424B3 filing that relates to China. It's in the form of an interview. I made it that way because it is easier to read and is more concise than the filing. If you want to check the context just refer to the page number below each paragraph. You should refer to the 424B3 filing to see all of the risks related to each subject mentioned here.
How does an American company obtain regulatory approval in China?
In China, regulatory approval for a product is granted only for products manufactured in China and only to the Chinese manufacturer of such product. As a result, for us to maintain control of our products in China, we plan to manufacture our products in China through a joint venture involving BTBP.
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Who is BTBP?
BTBP is a biotech company that manufactures multiple vaccines for both viral and bacterial infections. The National Vaccine & Serum Institute of the Peoples' Republic of China currently owns approximately 66% of BTBP's outstanding shares.
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How are you planning to penetrate the Chinese market?
We believe that the key to our penetration of the Chinese market will hinge on the success of the Beijing Calypte Joint Venture with Marr Technologies Limited in obtaining regulatory approval for and manufacturing and marketing our rapid HIV test products in China.
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What are the details of this agreement?
In November, 2003, we became the 51% owner of a joint venture, Beijing Calypte Biomedical Technology Ltd. (the "Beijing Calypte Joint Venture"), created to market existing and potential new products in the People's Republic of China ("China"). The remaining 49% of the joint venture is owned by Marr Technologies Limited, an affiliate of Marr Technologies BV ("Marr"), our largest stockholder, with a security ownership of approximately 27% of our outstanding stock as of December 16, 2004.
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What progress have you made in China to begin regulatory approval of your products?
On December 1, 2004, we announced that we had commenced a clinical trial program for our rapid HIV-1/2 test platform and our HIV-1 Western blot supplemental tests in The People's Republic of China. The trial will evaluate the sensitivity and specificity of our three rapid HIV-1/2 Antibody Tests; Blood, Oral Fluid and Urine. The trial will also evaluate the Company's HIV-1 Western Blot supplemental tests in Blood and Urine. We plan to test approximately 1,500 patients using no less than 7 locations that will perform the rapid HIV ½ tests and using at least 3 laboratories that will perform the HIV-1 Western Blot supplemental tests. We expect to complete the data collection by the end of this year and have a full statistical analysis available approximately two weeks after the last patient has been enrolled. We will release the performance results when the trials have been completed and certified by our Chinese contractor. Our objective is to file the required regulatory applications with the Chinese FDA (SFDA) in early 2005.
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How and where did you manufacture the product for the clinical trials?
… BTBP has made facilities available to us to manufacture the rapid test products required for clinical trials in China.
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I put together information out of a CC and the latest 424B3 filing that relates to China. It's in the form of an interview. I made it that way because it is easier to read and is more concise than the filing. If you want to check the context just refer to the page number below each paragraph. You should refer to the 424B3 filing to see all of the risks related to each subject mentioned here.
What details can you give us in terms of your full scale manufacturing plant in China?
CC 10/28/2004 (Dr. George)
“…We have already started to select our staff; we will start the training in advance of the time when we get approval. Once we have completed the clinical trials in China, you know, once we see what the results of this clinical trials are we’re going to know that approval is either going to be coming or it’s not going to be coming, cause we know what we have to achieve, in terms of performance. So, again this is all planed to be done concurrently with everything coming together before the time when we have the ability to start selling in China. If we can get the process done earlier, we might consider some exportation from that facility.”
What are your prospects for sales in China?
Early indications, based on meetings with Chinese authorities in which both we and representatives of our joint venture partner participated, lead us to expect that there is great potential for revenues from the sale of rapid HIV tests in China.
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What is the size of the market there?
From the CC 10/28/2004 (Dr George)
“… You know, the size of that market is really mind boggling. Because, China has such a – they have a significant and a serious problem with the spread of HIV in their population and China has now recognized the seriousness of that threat to their population and have recognized that if it is not addressed very quickly ant appropriately that it could actually begin to affect the economic growth that they have experienced in the last few years. Just to put it a little bit in perspective; sex workers in China; there are approximately 30 million of them that are known registered sex workers. The Chinese government tests those people every quarter. So, if you just do the math; four times 30 million that’s 120 million tests per year, just for that one small segment of the Chinese population. China has recently made the offer to their people, that, they will give a free AIDS test to anyone who request it. There are 1.3 billion people in China. I don’t mean to suggest that all 1.3 billion people are lined up for an HIV test, but someone who is administering that program in China and at the CDC, he said, about 600 million tests this year in the program and remember people who need testing for HIV don’t test one time. It’s a recurring need because people, being what they are, find out they’re negative and they see that as encouragement to continue to behave in the old ways. I think you get a sense, it’s a huge market. I think we have some good products for that market.”
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