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, and it is expected to be the first innovative targeted drug for lung cancer which is launched globally by a Chinese company.
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 1st, 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.
Ensartinib hydrochloride is expected be launched soon, and benefits ALK+ NSCLC patients. |
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