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Ensartinib hydrochloride is a potent and highly selective next-generation ALK inhibitor with independent intellectual property rights, and it is developed jointly by Betta Pharmaceuticals Co., Ltd. and its subsidiary Xcovey Holding, Inc. (Xcovery). Ensartinib hydrochloride is another product following the EGFR-TKI in Betta’s lung cancer pipeline.

In December, 2018, Betta submitted the new drug application (NDA) of ensartinib hydrochloride.

In February, 2019, ensartinib hydrochloride was granted the priority review by the National Medical Products Association (NMPA).

On January 1^st, 2020, the China phase II clinical results were published on the Lancet Respiratory Medicine (Yang, Y., et al., The Lancet Respiratory Medicine 8 (1) p45-53), which has an impact factor (IF) of 22.992. Dr. Ross Camidge, an international oncology expert and professor in the University of Colorado cancer center, commented that ensartinib had a clear efficacy and a good safety profile, and it could be the treatment of choice after crizotinib resistance, or a further first-line treatment of choice. 

In November 2020, Ensartinib Hydrochloride was approved for marketing in China.

In September 2021, the global first-line eXalt 3 study results of Enasidenib Hydrochloride were published in JAMA Oncology Journal.

In March 2022, Ensartinib Hydrochloride was approved for first-line treatment.

In December 2024, the U.S. marketing approval Ensartinib Hydrochloride was granted by the FDA, making it the first globally-marketed small-molecule innovative lung cancer targeted drug under the leadership of a Chinese company.