Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 26

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 1
Chunk 26
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 acceptance of these data is subject to certain conditions imposed by the FDA. For example, the clinical trial must be well designed and conducted by qualified investigators in accordance with current good clinical practices (“ GCPs”), including review and approval by an independent ethics committee and receipt of informed consent from trial patients. The trial population must also adequately represent the U. S. population, and the data must be applicable to the U. S. population and U. S. medical practice in ways that the FDA deems clinically meaningful. Generally, the patient population for any clinical trial conducted outside of the United States must be representative of the population for which we intend to seek approval in the United States. In addition, while these clinical trials are subject to applicable local laws, FDA acceptance of the data will be dependent upon its determination that the trials also comply with all applicable U. S. laws and regulations. There can be no assurance that the FDA will accept data from trials conducted outside of the U. S. If the FDA does not accept the data from our clinical trials conducted outside the United States, it would likely result in the need for additional clinical trials, which would be costly and time-consuming and delay or permanently halt our ability to develop and market these or other drug candidates in the United States. In April 2022, we received a Complete Response Letter from the FDA regarding the NDA for surufatinib for the treatment of pNETs and non-pancreatic NETs. The FDA determined that the data package submitted in the application, based on two successful Phase III trials in China and one bridging study in the U. S., were not sufficient to support approval in the U. S. The Complete Response Letter indicated that a multi-regional clinical trial would be required for U. S. approval. We subsequently withdrew our submissions to the FDA and the EMA for surufatinib.

In addition, there are risks inherent in conducting clinical trials in jurisdictions outside the United States including:

  regulatory and administrative requirements of the jurisdiction where the trial is conducted that could burden or limit our ability to conduct our clinical trials;  

  foreign exchange fluctuations;  
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  manufacturing, customs, shipment and storage requirements;  

  cultural differences in medical practice and clinical research; and  

  the risk that patient populations in such trials are not considered representative as compared to patient populations in the United States and other markets.  

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If we are unable to obtain and/or maintain priority review by the NMPA, fast