Sihuan Pharmaceutical Holdings Group Ltd is pleased to announce that XZP-5955 tablet (“XZP-5955”), a self-developed Category 1 new drug by the Group’s subsidiary Xuanzhu Biopharmaceutical Co., Ltd.* (軒竹生物科技有限公司 ) (“Xuanzhu Biopharm”), has received the notice for drug clinical trial approvals (No.: 2021LP00801; 2021LP00802; 2021LP00803) on 31 May 2021, becoming another innovative drug of the Group approved for clinical trial after XZP-5610 which was granted clinical trial approval in January 2021.
XZP-5955 shows high activity against a variety of TRK and ROS1 resistant mutations including TRKA-G595R, TRKA-G667C, TRKC-G623R and ROS1-G2032R. In a BaF3 LMNA-TRKA G595R xenograft model, XZP-5955 demonstrates dose dependent inhibition of tumor growth and leads to significant tumor regression or even complete tumor free.
The high brain penetration rate of XZP-5955 indicates a good therapeutic effect for patients with brain tumors or brain metastases with NTRK or ROS1 gene fusion and mutations. Pre-clinical data also show that XZP-5955 has higher safety window than similar products which indicates a better drug safety profile. Clinical experts in the industry believe that the pre-clinical research data of the drug show certain advantages and are looking forward to obtaining better efficacy and safety data in clinical trials, in order to provide a new choice for clinical doctors and patients.
Dr. Che Fengsheng, Chairman and Executive Director of Sihuan Pharmaceutical Holdings Group said: "XZP-5955 was self-developed by Xuanzhu Biopharm, has successfully obtained approval for the conduction of clinical trials from NMPA, which will further enrich the research and development pipeline for innovative drugs of the subsidiary. The therapeutic indications of the product include certain types of lung cancer, gastric cancer,sarcoma and other various solid tumors, and it has the opportunity to play its potential clinical value in both adults and children. It is expected to become the core product of the second-generation of NTRK and ROS1 inhibitors with global intellectual property rights and has positive impact on the operation results of the Group.”