Company: HMDCF
Filing Date: 2025-03-19
Form Type: 20-F
Source: 0001410578-25-000377
Chunk: 379

Company: HUTCHMED (China) Ltd
Filing Date: 2025-03-19
Form: 20-F
Item: Item 4
Chunk 379
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 important in frontline settings.
Another benefit of this new modality is to further optimize the anti-tumor activity of a small molecule, which may otherwise be limited by a narrow therapeutic window. Through a reduction of on-target/off-tumor toxicity, our platform is designed to deliver highly potent concentrations of small molecule inhibitors to target sites. This has potential to confer efficacy in a broad array of indications with high unmet needs and enable long-term usage. More generally, our ATTC platform has the potential to incorporate high molecular weight drug payloads such as proteolysis targeting chimeras (“PROTACs”) and protein-protein inhibitors (“PPIs”). 
Pre-clinical data suggests robust anti-tumor activity, durable response with our ATTC candidates when compared to monoclonal antibodies either alone and given in combination with targeted small molecule therapy in a variety of tumor types. IND-enabling work is ongoing and first global clinical trials, including in China, are expected to initiate in late 2025. Beyond these clinical stage candidates and ATTC candidates, we continue to research and discover new types of drug candidates, including those that address cancer-related apoptosis, cell signaling, epigenetics and protein translation and other novel technologies. The following picture contrasts the difference between the traditional ADC and the pioneering ATTC.
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Manufacturing
We have a drug product manufacturing facility in Suzhou which manufactures both clinical and commercial supplies for fruquintinib and surufatinib. Our new drug product facility in Shanghai is expected to increase our novel drug product manufacturing capacity by over five times. All our clinical supplies have completed technology transfer and are now being produced by our Shanghai factory. Our commercial supplies have also gradually migrated to this new facility, with significant production cost savings.
A commercial batch of savolitinib, which previously relied on a third-party manufacturer, was manufactured in the Shanghai factory in late 2024. This marked the first approval and delivery of commercial production from the Shanghai factory. We plan to complete site application and submission for surufatinib and fruquintinib in the second half of 2025, paving the way for their commercial production at the Shanghai factory.
We have established the FRUZAQLA® supply chain for the global markets including U.S., E.U. and Japan. Two drug product sites for supplying fruquintinib to the U.S. market have been qualified: our own facility in Suzhou and a second site in Switzerland. Both sites have already successfully delivered commercial batches for product launches