Novartis Breakthrough Drug Asciminib Gains China Approval Bringing Hope to Over 75 Countries

On May 14, Novartis achieved a major regulatory milestone as asciminib tablets were officially approved by China’s NMPA for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP).

This decision adds China to the growing list of over 75 countries, including the United States, Japan, and EU nations, where the therapy has already received market authorization. What sets asciminib apart is its revolutionary STAMP (Specifically Targeting the ABL Myristoyl Pocket) mechanism, a first-in-class and only-in-class approach that enables high specificity and reduces unwanted side effects. Instead of binding to the ATP pocket like traditional TKIs, asciminib interacts with a distinct allosteric site on the BCR-ABL protein, altering its conformation and enhancing patient tolerability.

Approved initially in October 2021 by the U.S. FDA under an accelerated pathway, asciminib has rapidly expanded its reach across major global markets. In October 2024, the FDA further extended its approval to include first-line use, solidifying its role as a frontline therapy.

China’s greenlight for this drug marks a significant advancement for patients with TKI resistance or intolerance. With six existing BCR-ABL inhibitors already approved in China, asciminib enters a crowded but critical landscape, offering a novel and more tolerable option.

This approval strengthens Novartis’ position in oncology innovation and provides new hope for thousands of patients who previously had limited options.