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

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