Sihuan Pharmaceutical Holdings Group Ltd. is pleased to announce that, Xuanzhu Biopharmaceutical Co., Ltd. (軒竹生物科技有限公司) (“Xuanzhu Biopharm”) of the Group has obtained approval for the commencement of phase III clinical trials from the Center for Drug Evaluation of the National Medical Products Administration (“NMPA”) in relation to Xuanzhu Biopharm’s new drug XZP-3621, which specific indication is ALK-positive advanced non-small cell lung cancer (NSCLC), marking the first product of Xuanzhu Biopharm in the NSCLC area entering into key development stage.
XZP-3621 is a next generation dual inhibitor of ALK/ROS1 for the treatment of NSCLC. Xuanzhu Biopharm expects to initiate phase III clinical trial for the first-line treatment of patients with ALK-positive advanced NSCLC in the near future. Clinical study results have shown that XZP-3621 has curative effects on both the initial treatment of ALK inhibitors and the treated ALK-rearranged advanced NSCLC patients; that XZP-3621 has better safety and a higher safety window compared to that of first and second generation ALK inhibitors. Preclinical research results show that: in vitro, XZP-3621 has excellent activity against multiple drug-resistant sites of the first/second generation ALK inhibitors; in vivo, pharmacodynamic model show that the efficacy is better than marketed drugs. XZP-3621 is expected to be the Best-in-class among the next generation ALK inhibitors.
Lung cancer is the world’s second most common malignant tumor with the highest mortality rate. According to the GLOBOCAN analysis report of global tumor epidemiology statistics in 2020, the number of new cases of lung cancer worldwide reached 2.207 million, second only to breast cancer; the number of deaths reached 1.796 million, ranking the first among all cancer types. In China, lung cancer is not only the malignant tumor with the highest incidence rate, but also the highest mortality rate. In 2020, it was estimated that the number of new cases of lung cancer in China will reach 816,000, accounting for 17.9% of all new cancers, and with number of deaths of 715,000, accounting for 23.8% of the total cancer deaths. NSCLC accounts for 85% of all lung cancers. 3%~5% of NSCLC patients have ALK mutations, and 1%~2% have ROS1 mutations. According to IQVIA data, in 2020, the total domestic ALK inhibitor (crizotinib, alectinib, ceritinib) market is approximately RMB1.828 billion.
Dr. Che Fengsheng, Chairman and Executive Director of Sihuan Pharmaceutical Holdings Group said: " New drug XZP-3621 was self-developed by Xuanzhu Biopharm, has successfully obtained approval for the conduction of phase III clinical trials from NMPA, which will further enrich the research and development pipeline for innovative drugs of the subsidiary. It is beneficial for the future market sales and competition of such drug, and will bring positive impacts to the operation results of the Group.”