Next-Generation ALK Inhibitor Dirozalkib Gets Approval in China, Offering New Hope for ALK-Positive Lung Cancer Patients
On August 22, 2025, the National Medical Products Administration (NMPA) officially approved the marketing of dirozalkib tablets, a Class 1 innovative drug independently developed by Xuanzhu Biopharmaceutical. This drug brings a breakthrough treatment option for patients with ALK-positive non-small cell lung cancer.
On August 22, 2025, the official website of the National Medical Products Administration (NMPA) released an announcement, formally approving the marketing of dirozalkib tablets (a Class 1 innovative drug) applied for by Xuanzhu Biotechnology. As a monotherapy, this drug is indicated for patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not received prior treatment with anaplastic lymphoma kinase (ALK) inhibitors, providing a brand-new treatment option for this patient population.
The approval of dirozalkib is based on a multicenter, randomized, open-label phase III clinical trial (NCT05204628), which compared its efficacy and safety with those of crizotinib, an existing ALK inhibitor. Data as of January 8, 2024, showed that dirozalkib exhibited significant antitumor effects: in treatment-naive patients with advanced ALK-positive NSCLC, the objective response rate (ORR) reached 86.9%, higher than the 81.2% of crizotinib; the median progression-free survival (mPFS) had not been reached (at the time of data cutoff), far exceeding crizotinib’s 12.94 months, and it could reduce the risk of disease progression or death by 57.8% (HR=0.422). Particularly in patients with brain metastases, dirozalkib showed more prominent advantages: the intracranial objective response rate (IC-ORR) reached 92.3%, significantly higher than crizotinib’s 11.1%; both the median intracranial duration of response (IC-DoR) and mPFS had not been reached, with a significant reduction in the risk of disease progression (HR=0.317).
As the 9th new drug in China indicated for patients with ALK-positive lung cancer, dirozalkib has stronger activity and higher selectivity for ALK, and can overcome potential drug resistance issues that may arise with crizotinib. Currently, Xuanzhu Biotechnology is also exploring the use of dirozalkib in postoperative adjuvant therapy for patients with ALK-positive NSCLC. It is expected to further expand its clinical applications in the future, bringing hope to more lung cancer patients.