By Fineline Cube 
Xuanzhu Biopharmaceutical Co., Ltd., a subsidiary of China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460), announced on August 22, 2025, that it had received marketing approval from China’s National Medical Products Administration (NMPA) for its self-developed Class 1 innovative drug, XZP-3621 (Dirozalkid) tablets. The drug is indicated for treating patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
Significant Milestone
XZP-3621 marks Xuanzhu’s second approved Class 1 innovative oncology drug, reflecting the company’s expansion from breast cancer to lung cancer therapies. This milestone underscores Xuanzhu’s commitment to its dual-engine strategy of “independent R&D + global presence.”
Pipeline and Impact
Xuanzhu is advancing over 10 clinical pipelines, including small and large molecule drugs, bispecific antibodies, and ADCs. The approval of XZP-3621 offers a groundbreaking treatment option for ALK-positive NSCLC patients in China, highlighting the company’s contribution to addressing unmet medical needs.-Fineline Info & Tech