Baiji Shenzhou PD-1 monoclonal antibody baizean ® Gain the seventh indication

Yiouda health on March 11, today, Baiji Shenzhou announced its independently developed PD-1 monoclonal antibody baizean ® (generic name: tirelizumab injection) added new indications for the treatment of adult patients with advanced solid tumors with unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene deficiency (dmmr). This approval is based on the results of a single arm, multicenter, open phase 2 clinical trial, rationale 209. The purpose of this test is to evaluate baizean ® Efficacy and safety of monotherapy in previously treated patients with locally advanced unresectable or metastatic MSI-H or dmmr solid tumors. The results show that baizean ® It has significant antitumor activity and survival benefit, and each tumor type shows a consistent trend of effectiveness results. With the approval of the new indication, baizean ® Seven indications have been obtained. Previously, baizean ® It has been approved by nmpa for the treatment of recurrent or refractory classical Hodgkin's lymphoma (CHL), locally advanced or metastatic urothelial carcinoma (UC), first-line advanced squamous NSCLC, first-line advanced non squamous NSCLC, second-line or third-line locally advanced or metastatic NSCLC, and hepatocellular carcinoma (HCC) after at least one systemic treatment. It is reported that baizean ® New indications for the treatment of locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) and first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) have also been accepted by nmpa and are currently under review.