Is acotinib/acalabrutinib officially launched in China and when will it be launched?

Acalabrutinib (Acalabrutinib), as a new generation Bruton's tyrosine kinase (BTK) inhibitor, has attracted widespread attention in the global field of hematological tumors since it was approved overseas. The drug is mainly used in the treatment of chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL) and other diseases. For a long time, most domestic patients have relied on ibrutinib for the choice of BTK inhibitors, and the introduction of acotinib has undoubtedly provided clinicians with a more precise and better-tolerated treatment option.

According to public information, acotinib has been officially approved by the National Medical Products Administration (NMPA) in China on August 29, 2023. The trade name is "Kangkeqi". The approval at this time not only means that domestic patients can finally directly use this internationally recognized new targeted drug, but also marks that China is accelerating the introduction of new drugs for hematological tumors.

Compared with the first generationBTK inhibitors, acotinib has an optimized molecular structure and can more selectively inhibit the BTK signaling pathway and reduce inhibition of other kinases, thus reducing the incidence of some adverse reactions. This feature makes its potential in long-term medication and combination therapy more prominent. In fact, since its approval in Europe and the United States, it has accumulated relatively sufficient clinical application experience, and its approval in the Chinese market is based on the support of a large amount of overseas real-world evidence and research data.

It is worth noting that the launch of acotinib is not only a change in drug supply, but also means the diversification of treatment options for patient groups. Especially for patients who need alternatives due to tolerance issues with ibrutinib, the arrival of acotinib provides new hope. Overall,the official approval in August 2023 has opened a new chapter for the treatment of hematological tumors in China.

Reference materials:https://www.calquence.com/