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| 1. |
How do you turn a Chinese Medicine into a Western medicine? |
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That depends on the original Chinese medicine but the main feature is to ensure the product passes through the appropriate regulatory framework, for example the FDA, to gain marketing approval in Western markets. For our botanical products, this entails additional clinical trials and ensuring manufacturing complies with international standards.
In June 2004 the FDA issued guidelines in relation to botanical products which we believe will allow botanical drugs to be developed quickly and more cheaply than conventional synthetic pharmaceuticals. The new guidelines recognise a history of use in humans as proof of safety and supports by-passing Phase I and direct entry into Phase II clinical trials.
For our synthetic and semi-synthetic drugs we first have to identify exactly which components of the TCM are active, via our screening technologies, and then develop new candidates based on that research. These then enter the regulatory process as for any new pharmaceutical. |
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| 2. |
Can you explain how you choose which TCM to begin working on? |
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We look for medicines which have a history of use in China within our core therapeutic areas of oncology and auto-immune diseases. |
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| 3. |
Can you give us more details on the trials of your lead products? When can we expect to hear about progress? |
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It is always difficult to put exact timings on clinical trials and that has to be borne in mind but we would expect our Phase I/IIa US trial for HMPL-002 in head and neck cancer to complete in 2009. Our US Phase IIb in Crohn's disease is expected to complete in 2008. |
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| 4. |
Have you already entered into partnering discussions for your lead products? What types of company are you targeting? |
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It is too early to make any comment on the details of our partnering programme beyond restating our broad strategy is to seek to out-licence our products at once they have reached late development, typically prior to Phase III. |
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| 5. |
How much does Chi-Med invest in its R&D each year? |
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We anticipate investing approximately $10 million per year over the next 3 years. |
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