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Inclusion in National Reimbursement Drug List

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HUTCHMED Announces Continued Inclusion of ELUNATE® (fruquintinib) and SULANDA® (surufatinib) in the National Reimbursement Drug List in China at Current Terms

Hong Kong, Shanghai & Florham Park, NJ - Wednesday, December 13, 2023: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM, HKEX:13) today announces that under the 2023 simple renewal mechanism of the China National Healthcare Security Administration ("NHSA"), on January 1, 2024 the updated National Reimbursement Drug List ("NRDL") will continue to include ELUNATE® (fruquintinib) and SULANDA® (surufatinib) at the same terms as the current two-year agreement.

Mr Hong Chen, Senior Vice President and Chief Commercial Officer (China) of HUTCHMED, said: "The NRDL has made it possible for our innovative medicines to quickly reach more patients in need across China. In the past few years, we have seen an array of new measures adopted by the NHSA, including the NRDL negotiation, the bidding process for non-exclusive medicines and simplified renewal rules for already listed medicines. Those new measures provided a solid foundation for the sustainable development of the innovative pharmaceutical industry and continuous improvement of patients' access to innovative medicines, allowing patients to truly benefit from healthcare innovations."

ELUNATE® was first included in the NRDL on January 1, 2020, for the treatment of metastatic colorectal cancer ("CRC"). CRC was the third most diagnosed form of cancer by incidence in China in 2020, with an estimated 555,000 new cases each year.[1]

SULANDA® was first included in the NRDL on January 1, 2022, for the treatment of non-pancreatic and pancreatic neuroendocrine tumors ("NETs"). In China, there were an estimated 71,300 newly diagnosed NET patients in 2020, with potentially up to 300,000 patients living with the disease.[2]

About the NRDL

The government in China has placed great importance on improving the affordability of drug treatments for the public. As of 2022, 1.35 billion people in China had basic medical insurance coverage, representing around 95% of the entire population. The NRDL is updated every year, and inclusion on the list is subject to renewal every two years. The NHSA annually convenes a broad network of experts in medicine, pharmacology, pharmacoeconomics and actuarial valuation to identify innovative medicines to consider for NRDL inclusion. Reimburse-ment of Category B medicines, including novel oncology medicines, requires varying degrees of copayment from patients, depending on their province or type of NHSA insurance scheme enrollment.

About Fruquintinib

Fruquintinib is a selective oral inhibitor of vascular endothelial growth factor receptors ("VEGFR")-1, -2 and -3. VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for high drug exposure, sustained target inhibition, and flexibility for the potential use as part of combination therapy. Fruquintinib has demonstrated a manageable safety profile and is being investigated in combinations with other anti-cancer therapies.

Fruquintinib is marketed in China by HUTCHMED under the brand name ELUNATE® following its approval in September 2018, in partnership with Eli Lilly and Company. Fruquintinib is marketed in the United States by its partner Takeda under the brand name FRUZAQLA™, following its approval in November 2023.

About Surufatinib

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFR and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body's immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects. It is marketed in China by HUTCHMED under the brand name SULANDA®.

Medical Information

[1] The Global Cancer Observatory. Accessed November 23, 2023.

[2] According to Frost & Sullivan. Report on file.

Cleaned text: letterheads, contacts and legal notices removed. View the original announcement ↗ · Company filings. Not investment advice.

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