break in in full fury! Section 4: domestic PD-1 antibody drugs will be approved soon

On November 13, Sina pharmaceutical was informed that the drug evaluation center (CDE) of the State Food and Drug Administration had finished the technical evaluation of its registration application for PD-1 "tirizumab", and had submitted it to the State Food and Drug Administration for approval on November 13, and the conclusion of the technical evaluation of varieties was "production approval" This means that the approval of tirizumab has entered a substantial stage Prior to that, Junshi biological "trepril mAb", "Cinda biological" sindili mAb "and Hengrui pharmaceutical" carrizumab "were approved for marketing successively, as well as two imported products, namely, Bristol Myers Squibb" nevulizumab "(drug o) and mosadong" pabolizumab "(drug K), which have taken the lead, with several indications respectively, as shown in the table below Table 1 five PD-1 antibodies and Baiji "tirelizumab" approved for marketing in China As the sixth anti-PD-1 antibody to be approved for market in China, "tirelizumab" does not occupy the first mover advantage, but it is more innovative and better than other domestic products of the same kind in clinical performance The data showed that the objective response rate of tirelizumab in nct3209973 was 85.7%, in which the complete response rate was 61.40%, and the response rate at 9 months was 84%, which was much higher than the clinical manifestations of nevulizumab and pabolizumab At present, there are PD-1 mAbs that can be better or best in the world On November 1, in an interview with the domestic media, WuXiaoBin, general manager and President of Baiji Shenzhou China, said that for PD-1, it's not marathon but 100m race Whether the product can succeed or not depends on the difference and characteristics In Hodgkin's lymphoma, the cure rate of drugs O and K was only 20%, while that of tirelizumab was as high as 60% It is reported that "tirelizumab" has also submitted an application for indications for the treatment of locally advanced or metastatic urothelial carcinoma (UC) which has been previously treated in China, and is expected to be approved by the market in 2020 In addition, Wang Lai, senior vice president of Baiji Shenzhou and head of global research, clinical operation and biostatistics and Asia Pacific clinical development, said, "tirelizumab" currently has 15 registered clinical trials, 11 of which are phase III clinical trials, including a phase III clinical study for patients with second-line or third-line non-small cell lung cancer (NSCLC) and a phase I clinical study for HCC Three stage clinical study of patients, one stage clinical study of patients with second-line esophageal squamous cell carcinoma (ESCC), one stage clinical study of patients with first-line gastric cancer (GC), one stage clinical study of patients with first-line esophageal squamous cell carcinoma (ESCC), etc Picture from Baiji Shenzhou financial report