Has filgotinib entered the domestic market?

Filgotinib(Filgotinib) is a targeted small molecule drug with an innovative mechanism. The drug mainly achieves anti-inflammatory and immune regulation effects by inhibiting the Janus kinase (JAK) signaling pathway and blocking the excessive activation of inflammation-related genes. Although filgotinib has become one of the important options for the treatment of moderate to severe rheumatoid arthritis, ulcerative colitis and other immune diseases in the European and American markets, it has not yet been officially approved for marketing in mainland China.

According to overseas data, filgotinib has been sold in many countries under the trade name of “Jyseleca”. However, it is still in the drug registration or review stage in China and has not yet been listed in the National Medical Products Administration (NMPA) drug catalog. Since it has not yet been officially launched in China, filgotinib has not yet been included in the national medical insurance directory, and patients are temporarily unable to obtain reimbursement through medical insurance channels. At present, if they need to use this drug, some patients will purchase the European or Japanese version of the original drug through cross-border medical or overseas pharmacy channels.

Figotinib in overseas markets usually comes in two specifications, namely100mg and 200mg tablets, with 28 or 30 tablets per box. The selling price varies depending on the country and exchange rate, and is approximately between RMB 10,000 and RMB 20,000. It is worth noting that although purchasing drugs overseas is feasible in some areas, use in China must be done under the guidance of a doctor to prevent drug interactions and risks caused by improper dosage.

The reason why filgotinib has not yet entered the Chinese market is mainly related to the regulatory approval cycle and drug safety assessment. During the approval process, European and American drug regulatory agencies strictly evaluated the risks of JAK inhibitor drugs (including thrombosis, cardiovascular events, infections, etc.), and Chinese regulatory authorities are also paying attention to their long-term safety and scope of indications. As the clinical value of JAK inhibitors in the field of autoimmunity continues to be verified, filgotinib is expected to be introduced into the Chinese market in the future to enrich treatment options for patients with chronic inflammatory diseases.

Reference materials:https://go.drugbank.com/drugs/DB14845