Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 495

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 4
Chunk 495
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 partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement of profits, or civil or criminal investigations and penalties brought by FDA and the U.S. Department of Justice (“DOJ”), or other governmental entities. Drugs are also subject to other federal, state and local statutes and regulations.
Our drug candidates must be approved by the FDA through the NDA process before they may be legally marketed in the United States. The process required by the FDA before a drug may be marketed in the United States generally involves the following:

●   completion of extensive pre-clinical studies, sometimes referred to as pre-clinical laboratory tests, pre-clinical animal studies and formulation studies all performed in compliance with applicable regulations, including the FDA’s good laboratory practice regulations;
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●   submission to the FDA of an IND application which must become effective before human clinical trials may begin and must be updated annually;
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●   IRB approval before each clinical trial may be initiated;
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●   performance of adequate and well-controlled human clinical trials in accordance with study protocols, the applicable GCPs and other clinical trial-related regulations, to establish the safety and efficacy of the proposed drug product for its proposed indication;
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●   preparation and submission to the FDA of an NDA;
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●   a determination by the FDA within 60 days of its receipt of an NDA whether the NDA is acceptable for filing; if the FDA determines that the NDA is not sufficiently complete to permit substantive review, it may request additional information and decline to accept the application for filing until the information is provided;
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●   in-depth review of the NDA by FDA, which may include review by a scientific advisory committee;
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●   satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the active pharmaceutical ingredient and finished drug product are produced to assess compliance with the FDA’s cGMP;
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●   potential FDA audit of the pre-clinical and/or clinical trial sites that generated the data in support of the NDA;
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●   payment of user fees and FDA review and approval of the NDA prior to any commercial marketing or sale of the drug in the United States; and
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●   compliance with any post-approval requirements, such as REMS and post-approval studies required by FDA.
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Pre-clinical Studies