Maike Pharmaceutical-B announced that in the critical phase III clinical trial of MT1013, the company's core product, all enrolled participants have completed the study and treatment and follow-up procedures stipulated in all trial plans, and have left the group. The trial was a multicenter, randomized, double-blind, double-blind simulation study comparing MT1013 with cinacalcet in CKD-SHPT patients undergoing maintenance hemodialysis. A total of 435 patients were enrolled. As of the announcement date, according to existing safety monitoring data, no new major safety risk signals had been detected, and the overall drop off situation of the subjects was basically in line with expectations during the test design phase. The test has yet to be revealed, and the relevant data is still awaiting verification and final statistical analysis. Follow-up work includes data cleaning, database locking, decontamination, and statistical analysis.

Zhitongcaijing · 2d ago
Maike Pharmaceutical-B announced that in the critical phase III clinical trial of MT1013, the company's core product, all enrolled participants have completed the study and treatment and follow-up procedures stipulated in all trial plans, and have left the group. The trial was a multicenter, randomized, double-blind, double-blind simulation study comparing MT1013 with cinacalcet in CKD-SHPT patients undergoing maintenance hemodialysis. A total of 435 patients were enrolled. As of the announcement date, according to existing safety monitoring data, no new major safety risk signals had been detected, and the overall drop off situation of the subjects was basically in line with expectations during the test design phase. The test has yet to be revealed, and the relevant data is still awaiting verification and final statistical analysis. Follow-up work includes data cleaning, database locking, decontamination, and statistical analysis.