Heng Rui

Heng Rui: Fast start PD-1 + Apatinib International Multicenter Phase III Hepatocellular Carcinoma; Domestic PD-1 review completed

At present, the SHR-1210 review has been completed. Who will be the third domestically produced PD-1 remains to be seen uuuuuuuuuuuuu

And Hengrui: Official launch of PD-1 + Apatinib International Multicenter Phase III Hepatocellular Carcinoma!

Heng Rui announced on December 22 last year that:

Recently, Jiangsu Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as "Hengrui Pharmaceutical" or "Company") communicated with the Food and Drug Administration of the United States (hereinafter referred to as "FDA") on the international multicenter phase III clinical trial of the company's anti-PD-1 antibody SHR-1210 combined with Apatinib mesylate for the first-line treatment of hepatocellular carcinoma, which will be carried out simultaneously in the United States, Europe and China. 。 The review team led by Dr. Patricia Keegan of the FDA oncology department and the Head of Hengrui Medical Science reached agreement on the overall design of phase III clinical trial program, patient selection, primary endpoint, secondary endpoint, efficacy evaluation, statistical analysis method and related details. The FDA agreed to the upcoming phase III clinical trial and to set the details in the progression-free survival period. When the result reaches the preset statistical standard, the production will be declared in advance.

It also discloses that the sales of Apatinib Mesylate are about 1.3 billion RMB. Up to now, the company has invested about 345 million yuan in R&D expenditure on related projects.