Has mivamutide injection been officially launched in the country?

As ofJune 2025,Mifamurtide injection (Mifamurtide) has not been officially approved for marketing by the China State Food and Drug Administration. This drug has been approved by the European Union for the adjuvant treatment of osteosarcoma after surgery as early as 2009. The trade name is "Mepact" and is commercially promoted by Takeda in the European market. Its indication is postoperative immune consolidation therapy for patients with high-grade osteosarcoma without distant metastasis. Although it is widely used in adolescents and young adults in Europe, it has not yet been formally approved for marketing by the U.S. Food and Drug Administration (FDA), mainly because survival data did not fully meet regulatory requirements at the time.

For the Chinese market, there is currently no public registration information for the launch of mivamut peptide, and it has not been included in the national medical insurance or innovative drug negotiation catalog. At present, this drug is not included as a routine recommended drug in domestic clinical guidelines or authoritative consensus documents in the field of bone tumors. This means that domestic patients are temporarily unable to obtain treatment with this drug through regular hospitals. Nonetheless, as the country has gradually accelerated the review and approval process for overseas orphan drugs and tumor immunotherapy drugs in recent years, the possibility of Mifamurtide entering the Chinese market in the future cannot be ruled out.

At present, if domestic patients want to use this drug, they often need to use overseas channels, Hong Kong prescriptions, or participate in international multi-center clinical trials. However, relevant paths need to be treated with caution, especially to ensure that the drug source is legal, storage and transportation are stable, and that professional doctors conduct efficacy and risk assessments. While waiting for its official introduction, patients should continue to rely on existing standard treatments, including surgery and multi-drug combination chemotherapy, and pay attention to the latest announcements and industry trends from NMPA in order to learn about drug launch news as soon as possible.

Reference materials:https://en.wikipedia.org/wiki/Mifamurtide