When will Asiminib/Aximinibe be launched? Domestic approved indications

Asciminib, the Chinese trade name is Asciminib hydrochloride tablets and the English brand name is Scemblix, is an innovative targeted therapy drug that was officially approved by the China National Medical Products Administration for marketing in China on May 14, 2025. This approval marks that Chinese patients have ushered in a new treatment option with a more precise mechanism for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) chronic phase (CP). Asnib is an oral targeted drug developed by Novartis. It is the world's first and currently only STAMP inhibitor. Its mechanism of action is different from traditional ATP-competitive BCR-ABL inhibitors.

Compared with the currently widely used first- and second-generation TKIs such as imatinib, dasatinib or nilotinib, asinib targets the novel "myelyl pocket" structural site of ABL kinase, so it can produce better efficacy in patients with partial drug resistance or T315I mutation, especially for CML patients who have failed multiple lines of treatment. It has clinical value. As early as 2021, Asnib was approved for marketing in the United States for the treatment of patients with chronic phase CML who have failed two or more TKI treatments. Now that the drug has officially entered the Chinese market, it is expected to fill some of the treatment gaps.

The domestically approved indications are: for the treatment of newly diagnosed adult patients with Ph+ CML-CP. This is an indication range with important clinical significance. Especially in the current context of increasing resistance to multiple TKIs, the launch of asinib provides a new treatment option for initially treated patients, and may further improve the long-term remission rate and quality of life by optimizing the medication mechanism.

At present, due to the short time on the market in China, the drug has not yet been included in the national medical insurance catalog, and the specific official market retail price has not been announced. But referring to its pricing in overseas markets, its price may be at a relatively high level. However, some overseas versions of generic drugs (such as Indian or Laos versions) have begun to circulate, and the prices are relatively affordable, but the specific selection still needs to be made under the guidance of a doctor.

Reference materials:https://www.novartis.com/our-products/pipeline/asciminib