Hutchmed Confirms Orpathys Retained in China’s National Reimbursement Drug List at Existing Terms

Hutchmed (China) Limited, a forward-thinking biopharmaceutical firm in the commercial phase, has declared the continuation of Orpathys (savolitinib) in the updated National Reimbursement Drug List (NRDL), following the renewal agreement with China’s National Healthcare Security Administration (NHSA). Scheduled to come into effect on January 1, 2025, the list will retain Orpathys under the terms of the currently active two-year contract.

Orpathys is a powerful and highly specific oral MET tyrosine kinase inhibitor (TKI). It received conditional approval in China in June 2021 to treat specific individuals with non-small cell lung cancer (NSCLC) showing MET exon 14 skipping mutations. With China housing over one-third of the global lung cancer population, among NSCLC patients, about 2-3% are affected by tumours with MET exon 14 skipping mutations.

The inclusion of Orpathys into the NRDL was initially on March 1, 2023. China’s government emphasizes enhancing the public accessibility of drug therapies. By the end of 2023, basic medical insurance covered 1.33 billion people in China, equating to roughly 95% of the populace. The NRDL undergoes annual updates, and its listing status is renewed biennially. NHSA organizes an extensive group of specialists from various fields, like medicine, pharmacology, pharmacoeconomics, and actuarial sciences, who contribute to evaluating innovative treatments for NRDL entries. Patients must make co-payments of varying degrees for Category B medicines, which include new oncology drugs, contingent on their province or NHSA insurance scheme.

Orpathys (savolitinib) is a powerful oral MET TKI with shown efficacy in advanced solid tumors. It obstructs unusual MET receptor tyrosine kinase pathway activations caused by mutations (like exon 14 skipping mutations or others), gene amplifications, or protein overexpression.

Developed collaboratively by Hutchmed and AstraZeneca and commercialized by AstraZeneca, Orpathys is authorized in China for treating NSCLC patients with MET exon 14 skipping mutations who have either progressed after prior systemic treatments or cannot undergo chemotherapy. It stands as the first approved selective MET inhibitor in China and the inaugural one on the NRDL. Orpathys is under clinical trials for several cancer types, such as lung, kidney, and stomach cancer, both independently and in combination with other drugs.

Hutchmed is a pioneering, commercial-stage biopharmaceutical entity focused on finding, globally developing, and commercializing targeted therapies and immunotherapies for treating cancer and immune diseases.