Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 25

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 1
Chunk 25
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 or limit their approval of such drug candidates;  
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  regulatory authorities may require the addition of labeling statements, such as a “ boxed ” warning or a contra-indication;  
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  we may be required to create a medication guide outlining the risks of such side effects for distribution to patients;  
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  we may be required to change the way such drug candidates are distributed or administered, conduct additional clinical trials or change the labeling of the drug candidates;  
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  regulatory authorities may require a Risk Evaluation and Mitigation Strategy ( “ REMS ”), plan to mitigate risks, which could include medication guides, physician communication plans, or elemen...  
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  we may be subject to regulatory investigations and government enforcement actions;  
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  we may decide to remove such drug candidates from the marketplace;  
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  we could be sued and held liable for injury caused to individuals exposed to or taking our drug candidates; and  

  our reputation may suffer.  
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Table of Contents

Any of these events could prevent us from achieving or maintaining market acceptance of the affected drug candidates and could substantially increase the cost of commercializing our drug candidates, if approved, and significantly impact our ability to successfully commercialize our drug candidates and generate revenue.

We and our collaboration partners have conducted and intend to conduct additional clinical trials for certain of our drug candidates at sites outside the United States, and the FDA may not accept data from trials conducted in such locations or may require additional U. S.-based trials.

We and our collaboration partners have conducted, currently are conducting and intend in the future to conduct, clinical trials outside the United States, particularly in China where our Oncology/Immunology operations are headquartered as well as in other jurisdictions such as Australia, Japan, South Korea and various European countries.

Although the FDA may accept data from clinical trials conducted outside the United States,