OPERATIONS REVIEW
ONCOLOGY/IMMUNOLOGY
HUTCHMED discovers, develops, manufactures and markets targeted therapies and immunotherapies for the treatment of cancer and immunological diseases through a fully integrated team of approximately 890 scientists and staff, and an in-house oncology commercial organization of approximately 740 staff, based in Shanghai, Suzhou, Beijing and Hong Kong in China and New Jersey in the US.
Out of our 13 drug candidates in various stages of clinical trials, four medicines, fruquintinib, surufatinib, savolitinib and tazemetostat, have been approved in mainland China. Fruquintinib has also been approved in or launched in more than 30 countries, including the US, EU and Japan as of July 2025. Savolitinib has completed an overseas Phase II study and an ongoing Phase III study will potentially support global filings if data proves satisfactory. Our fifth medicine, sovleplenib, has been accepted for review by the NMPA in China, pending approval. Beyond these drug candidates, our novel discovery and early-stage development is focused on progressing drug candidates from our ATTC next-generation technology platform, which currently has several molecules in the pre-clinical stage.
RESEARCH & DEVELOPMENT
With US, EU and Japan approvals of fruquintinib in November 2023, June 2024 and September 2024, respectively, we now possess a track record of discovery, clinical development and regulatory submissions of an innovative medicine launched globally. Our strategy is aimed at accelerating our path to establish a long-term sustainable business, by prioritizing late-stage and registrational studies in China and partnering outside of China. HUTCHMED intends to continue to run early phase development programs for selected drug candidates internationally where we believe we can differentiate from a global perspective.
HUTCHMED plans to accelerate innovation through artificial intelligence (AI) integration, with a focus on key R&D stages to improve return on investment (ROI) and iterative learning. In the near term, we plan to expedite the identification of high-potential drug candidates and reduce late-stage pre-clinical attrition. In the medium-term, we target faster patient recruitment through better screening and clinical trial design, leading to R&D efficiency gain with an integrated AI platform.
Antibody-Targeted Therapy Conjugate Technology Platform
In January 2025, HUTCHMED announced its next-generation in-house technology platform in antibody-targeted therapy conjugates, or ATTCs. For over three years, we have invested significant resources into this new platform, which should provide multiple drug candidates in the future. Compared to traditional cytotoxin-based antibody-drug conjugates, the traditional toxin-based payload is replaced with a targeted small molecule. Thus, unlike traditional antibody-drug conjugates, ATTCs have potential to be administered in combination with chemotherapy or other targeted agents, which is particularly important in frontline settings.
Another benefit of such design is to further optimize the strength of the small-molecule drug, which may otherwise be limited by a narrow therapeutic window. Through a reduction of off-tumor or off-target 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 to date suggests robust anti-tumor activity and durable response with our ATTC candidates, compared to monoclonal antibodies 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.
Below is a summary update of the clinical trial progress of our investigational drug candidates. For more details about each trial, please refer to recent scientific publications.