Betta Pharmaceuticals(300558.SZ): Publication of clinical research results on postoperative adjuvant therapy with Anlotinib

Betta Pharmaceuticals (300558.SZ) announced today that the full text of the research on the postoperative adjuvant treatment of ALK-positive non-small cell lung cancer (NSCLC) with the company's independently developed Enasidenib hydrochloride capsules (trade name: Bemurina, referred to as "Enasidenib") has been published online in the prestigious international medical journal "New England Journal of Medicine" (impact factor: 84.5). The publication of the ELEVATE study signifies the international recognition of the clinical value of Enasidenib in the field of postoperative adjuvant treatment, providing high-level evidence for postoperative adjuvant treatment for NSCLC patients. The ELEVATE study involved a total of 56 domestic medical centers and is currently a multicenter, randomized, double-blind phase III registration study in the field of postoperative adjuvant treatment for ALK-positive lung cancer in stages IB-IIIB. The study included subjects aged 18 years and above who had undergone complete resection (R0) and were pathologically confirmed to have ALK-positive NSCLC in stages IB, II, IIIA, and IIIB (only T3N2M0) by central laboratory confirmation, with disease staging according to the 8th edition of the American Joint Committee on Cancer (AJCC)/International Union Against Cancer (UICC) lung cancer staging criteria; subjects were allowed to receive postoperative adjuvant chemotherapy for NSCLC. The study results showed that as of June 26, 2025, in patients with stage II-IIIB, both groups had a median follow-up time of 24.0 months. The DFS HR was 0.20 (95% CI: 0.11-0.38; p <0.0001); the 2-year DFS rate was 86.4% in the Enasidenib group and 53.5% in the placebo group. In the ITT population, the DFS HR was 0.20 (95% CI: 0.10-0.37; p <0.0001); the 2-year DFS rate was 87.3% in the Enasidenib group and 57.2% in the placebo group. The DFS benefit trend favoring Enasidenib was consistent across all subgroups. A benefit in CNS-DFS was observed in the ITT population (HR 0.22; 95% CI: 0.08-0.60). OS is currently not mature. The safety profile was consistent with the known safety of Enasidenib.