Xuan Fei Ning (dirozalkib) / Sihuan Pharmaceutical - LARVOL DELTA

Expert consensus on iruplinalkib for the treatment of ALK-positive non-small cell lung cancer (2026 edition) (PubMed, Zhonghua Zhong Liu Za Zhi) - "Currently, the China National Medical Products Administration (NMPA) has approved ten ALK-TKIs, including crizotinib, ceritinib, alectinib, ensartinib, brigatinib, lorlatinib, iruplinalkib, envonalkib, dirozalkib and conteltinib. This consensus provides systematic and comprehensive update of clinical research data on iruplinalkib published before June 25, 2026, based on the 2024 edition. It covers common clinical issues and provides corresponding recommendations for the use of iruplinalkib in the treatment of ALK-positive NSCLC."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Dirozalkib in patients with advanced ALK-positive non-small cell lung cancer (NSCLC): Results from a phase 2 study (AACR 2026) - P2 | "Cohort A enrolled pts with ALK inhibitor-naïve, Cohort B included pts previously treated with only crizotinib, and Cohort C included pts previously treated with other ALK inhibitors ± crizotinib. Both ctDNA testing results and clinical data demonstrated the promising efficacy of dirozalkib in patients with advanced ALK-positive NSCLC."

Clinical • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Dirozalkib versus crizotinib in advanced ALK-positive non-small cell lung cancer (NSCLC): Results from the multicenter, randomized, open-label phase 3 trial (AACR 2026) - P3 | "Dirozalkib demonstrated significant improvement in PFS compared with crizotinib for ALK-positive advanced NSCLC. Notably, it showed robust intracranial antitumor activity and durable treatment responses in pts with brain metastases at baseline. *mITT: eight pts were excluded from ITT population due to unavailable information regarding the regulatory approval status of the NGS kits used for ALK rearrangement testing at baseline."

Clinical • Metastases • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Sihuan’s Xuanzhu Unit Posts Strong Phase III Lung Cancer Data for ALK Inhibitor Dirozalkib (The Globe and Mail) - "The multicenter, randomized trial compared dirozalkib with crizotinib in 275 patients, assessing progression-free survival as the primary endpoint along with key response and safety measures. The study showed dirozalkib more than doubled median progression-free survival versus crizotinib, significantly improving objective response, duration of response and disease control while delivering strong intracranial tumor responses and markedly lower brain progression risk."

P2 data • Non Small Cell Lung Cancer

Preclinical characterization and first-in-human, phase I trial of the novel ALK inhibitor dirozalkib in advanced non-small cell lung cancer. (PubMed, Eur J Cancer) - P1 | "Dirozalkib exhibited favorable safety, antitumor activity and pharmacokinetics in patients with advanced ALK-rearranged NSCLC. The recommended phase II dose was 500 mg/day."

First-in-human • Journal • P1 data • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • ROS1

Presence of drug-drug interactions between esomeprazole and an ALK tyrosine kinase inhibitor (Dirozalkib). (PubMed, Cancer Chemother Pharmacol) - No abstract available

Journal

THE INNOVATIVE DRUG…OBTAINED DRUG REGISTRATION APPROVAL FROM NMPA (HKEXnews) - "Sihuan Pharmaceutical Holdings Group...is pleased to announce that...Dirozalkib Tablets (formerly known as 'Dexitinib', XZP-3621, brand name: Xuan Fei Ning)...has obtained a drug registration approval from the National Medical Products Administration (the 'NMPA') for the treatment of ALK-positive advanced non-small cell lung cancer ('NSCLC')."

China approval • Non Small Cell Lung Cancer

A Phase I Study of XZP-3621 in Chinese Patients With ALK or ROS1 Rearrangement Non-small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=114 | Completed | Sponsor: Xuanzhu Biopharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • ROS1

Food Effect and Mass Balance Study of XZP-3621 Tablets (clinicaltrials.gov) - P1 | N=34 | Completed | Sponsor: Xuanzhu Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion

ANNOUNCEMENT OF INTERIM RESULTS FOR THE SIX MONTHS ENDED 30 JUNE 2024 (HKEXnews) - "In January 2024, Bireociclib passed the registration on-site inspection and GMP compliance inspection, and the review of the NMPA is progressing smoothly...In April 2024, the NDA of 'Dexitinib Tablets' (code: XZP-3621), a Class 1 innovative drug independently developed by Xuanzhu Biopharm, was accepted by the Center for Drug Evaluation (CDE), NMPA. It is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC)."

China filing • Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of the Absorption, Metabolism and Excretion of [14C]XZP-3621 in Human (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Xuanzhu Biopharmaceutical Co., Ltd.

New P1 trial

Drug-drug Interaction Study of XZP-3621 Tablet (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: Xuanzhu Biopharmaceutical Co., Ltd.

New P1 trial

A Study of XZP-3621 in Chinese Patients With ALK Positive NSCLC (clinicaltrials.gov) - P2 | N=190 | Not yet recruiting | Sponsor: Xuanzhu Biopharmaceutical Co., Ltd.

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study to Evaluate and Compare the Efficacy and Safety of XZP-3621 Versus Crizotinib (clinicaltrials.gov) - P3; N=238; Not yet recruiting; Sponsor: Xuanzhu Biopharmaceutical Co., Ltd.

New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor