SIHUAN PHARM (00460) announced that Lovalac tablets (formerly known as "Daxitinib," XZP-3621, trade name: Xuanfeining®), a Class 1 innovative ALK inhibitor drug independently developed by its non-wholly owned subsidiary Xuanzhu Biotechnology Co., Ltd., has received marketing approval from China's National Medical Products Administration (NMPA) for the treatment of anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

This product represents Xuanzhu Biotechnology's third Class 1 innovative drug to receive marketing approval and its second Class 1 innovative oncology drug, marking a continued breakthrough in the company's oncology research and development from breast cancer to lung cancer targeted therapies.

Lovalac demonstrates four core advantages: (1) Rapid onset: Through unique molecular structure design, Lovalac significantly enhances drug bioavailability, enabling rapid inhibition of tumor progression and securing critical treatment windows for patients. (2) Exceptional tumor suppression strength: In pivotal Phase III clinical trials, Lovalac demonstrated significant superiority over marketed first- and second-generation ALK inhibitors in treating ALK-positive advanced NSCLC patients, showing potent inhibitory activity against resistance mutations including G1202R and I1171N. (3) Durable response: Patient benefit duration is significantly extended, establishing a foundation for long-term disease stability. (4) Significant survival benefit: Truly achieving the goal of "chronic disease management."

Additionally, Lovalac successfully addresses clinical challenges, achieving dual breakthroughs in brain metastasis control and safety. Its high efficiency in penetrating the blood-brain barrier effectively addresses deficiencies in central nervous system protection found in existing therapies.

In terms of safety, Lovalac demonstrates significant advantages, with adverse reactions primarily manifested as digestive tract reactions such as diarrhea and vomiting, mostly Grade 1-2, which can be alleviated or resolved through symptomatic treatment and/or dose adjustment. Furthermore, risks of pleural effusion and hepatotoxicity are significantly reduced, substantially improving patients' long-term medication compliance.