XUANZHUBIO-B (02575) announced that the Group presented results from the Phase III DIAMOND-2 clinical study of Diraok as a first-line treatment for anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) in an oral presentation at the 2026 American Association for Cancer Research Annual Meeting, held from April 17 to April 22, 2026. The DIAMOND-2 study (NCT05204628) is a multicenter, randomized, open-label Phase III clinical trial conducted in China, using crizotinib as a control, designed to head-to-head evaluate the efficacy and safety of Diraok compared to crizotinib in patients with previously untreated ALK-positive advanced NSCLC. The study enrolled a total of 275 subjects, who were randomized in a 1:1 ratio to receive either Diraok (500mg, once daily) or crizotinib (250mg, twice daily). The primary endpoint was investigator-assessed progression-free survival (PFS), with secondary endpoints including objective response rate (ORR), duration of response (DoR), intracranial objective response rate (IC-ORR), and safety. Data presented at the 2026 AACR showed that Diraok demonstrated statistically significant and clinically meaningful efficacy advantages in the first-line treatment of ALK-positive advanced NSCLC. In the modified intention-to-treat (mITT) population, the investigator-assessed median PFS (mPFS) reached 31.3 months, significantly superior to the control group's 12.9 months, representing a 53% reduction in the risk of disease progression (HR=0.47, P<0.0001). Furthermore, the Diraok group achieved an ORR of 88.5%, a median DoR (mDoR) of 32.10 months, and a disease control rate (DCR) of 95.4%, with both depth and durability of tumor response significantly better than the control group. In patients with measurable intracranial lesions at baseline, Diraok showed prominent intracranial anti-tumor activity, with an IC-ORR as high as 91.7% compared to only 11.1% in the control group. Diraok also significantly prolonged intracranial progression-free survival, reducing the risk of intracranial disease progression by 55% (HR=0.45, P=0.0003). Regarding safety, Diraok was generally well-tolerated, with adverse events primarily consisting of Grade 1-2 gastrointestinal reactions. The proportion of patients who discontinued treatment due to Diraok-related adverse events was only 1.5%, indicating a more favorable clinical safety profile.