Novartis' ABL1 Allosteric Inhibitor Asciminib (ABL001) Granted Clinical Trial Approval in China, NDA Already Submitted in the U.S.

Today, a public announcement from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) indicates that Novartis's Class 1 new drug, ABL001 tablets, has been granted implicit approval for two clinical trials. The drug is intended for the treatment of adult patients with chronic phase chronic myeloid leukemia (CML). Publicly available information shows that asciminib (ABL001) is an ABL1 allosteric inhibitor. It has previously received Fast Track designation and Breakthrough Therapy designation from the U.S. FDA, and Novartis has submitted a New Drug Application (NDA) for the drug to the agency.

Screenshot source: CDE Official Website