Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 13

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 1
Chunk 13
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ib, fruquintinib, surufatinib and/or our other drug candidates is unsuccessful or perceived as disappointing, our stock price could decline significantly and the long-term success of the product and our company could be harmed.

All of our drug candidates are still in development. If we are unable to obtain regulatory approval and ultimately commercialize our drug candidates, or if we experience significant delays in doing so, our business will be materially harmed.

All of our drug candidates are still in development, including those that have already received approval for the treatment of certain indications in China and United States. Although we may receive payments from our collaboration partners, including upfront payments and payments for achieving development, regulatory or commercial milestones, for certain of our drug candidates, our ability to generate significant revenue from our drug candidates is dependent on their receipt of additional regulatory approval and successful commercialization, which may never occur. Each of our drug candidates in development will require additional pre-clinical and/or clinical trials, regulatory approval in multiple jurisdictions, and substantial investment in manufacturing and significant efforts before we generate significant revenue from product sales. The success of our drug candidates will depend on several factors, including the following:

  successful completion of additional pre-clinical and/or clinical trials;  

  successful enrollment in, and completion of, additional clinical trials;  

  receipt of additional regulatory approvals from applicable regulatory authorities for planned clinical trials, future clinical trials, drug registrations or post-approval trials;  

  successful completion of all studies required to obtain regulatory approval and/or fulfillment of post-approval requirements in the United States, China, Europe, Japan and other jurisdictions f...  

  adapting our commercial manufacturing capabilities to the specifications for our drug candidates for clinical supply and commercial manufacturing;  

  obtaining and maintaining patent and trade secret protection or regulatory exclusivity for our drug candidates;  

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  launching commercial sales of our drug candidates, if and when approved, whether alone or in collaboration with others;  

  acceptance of the drug candidates, if and when approved, by patients, the medical community and third-party payors;  

  effectively competing with other therapies;  

  obtaining and maintaining healthcare coverage and adequate reimbursement;  

  enforcing and defending intellectual property rights and claims; and  

  maintaining a continued acceptable safety profile of the drug candidates following approval.  

If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize our drug candidates, which would materially harm our business.

Our primary approach