Betta Pharmaceuticals discloses clinical research progress on ensartinib for postoperative adjuvant indications
August 25, 2025
Source: drugdu
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Betta PharmaceuticalsOn the morning of August 25th, the company announced that in April 2022, the National Medical Products Administration (NMPA) approved the clinical trial of Ensartinib Hydrochloride Capsules (Bemena®, hereinafter referred to as "Ensartinib") for the adjuvant treatment of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) after surgery. Recently, an interim analysis of the clinical trial, as assessed by the Independent Data Monitoring Committee (IDMC), demonstrated positive results, meeting the study's pre-specified primary endpoint and demonstrating statistically significant and clinically important benefits. Detailed data from this study will be presented at a major international academic conference this year. The company's team is actively preparing application materials and aiming to submit the NDA for this new indication as soon as possible.
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