The 6th domestically produced PD-1 will be approved soon

Finishingrainbow

Today, Sina Pharmaceuticals inquired on the official website of the State Food and Drug Administration and found that the recombinant fully human anti-PD-1 monoclonal antibody developed by Yuheng Pharmaceutical/WuXing Biologics-Sepalizumab injection (GLS-010 injection), used For the treatment of patients with relapsed or refractory classic Hodgkin’s lymphoma (r/r cHL) above the second-line level, it has entered the “under review” status and is expected to be approved by the NMPA in the near future.

GLS-010 injection is the first fully human anti-PD-1 single screened by the genetically modified animal platform that was developed by WuXi Biologics, led by Beijing Cancer Hospital and participated by a number of domestic clinical scientific research institutions to complete the clinical trial application.

Data show that the Phase II (NCT03655483) trial study of GLS-010 injection for the treatment of Chinese patients with relapsed or refractory cHL included a total of 85 patients with relapsed or refractory cHL who had previously received at least 2 types of systemic chemotherapy.

Trial data showed that as of August 2, 2019, at a median follow-up of 6.

In addition, GLS-010 injection was certified as a breakthrough therapy by CDE in March this year for the treatment of recurrence or metastasis, PD-L1 positive (CPS≥1) cervical cancer that has progressed after receiving first-line or more platinum-containing standard chemotherapy.

It is worth mentioning that as early as 2017, Yuheng Pharmaceutical and WuXi Biologics reached a cooperation agreement with an overseas company, Arcus Biosciences, to exclusively license the company's international rights and interests in the PD-1 antibody GLS-010

Reference source: official website of the State Food and Drug Administration, Medical Cube Info, corporate press release