Two anti-PD-L1 McAbs are to be included in the breakthrough treatment

February 01, 2021

On January 28, 2021, CDE announced the list of two breakthrough treatment varieties to be included.

Source: CDE website

1. Zhaoke anti-PD-L1 monoclonal antibody is to be included in breakthrough treatment

Zhaoke PD-L1 monoclonal antibody zkab 001, a subsidiary of Li's Pharmaceutical factory, was recognized by CDE as a breakthrough therapy. Its indication is recurrent and metastatic cervical cancer that has failed or not tolerated the first-line platinum containing regimen. Zkab001 is a PD-L1 monoclonal antibody introduced by Li's pharmaceutical company from Sorrento company of the United States. At present, eight clinical trials have been carried out. The clinical indications include osteosarcoma, esophageal squamous cell carcinoma, cervical cancer, urothelial carcinoma, small cell lung cancer and melanoma. The indications of osteosarcoma are the fastest growing, and have progressed to stage III clinical stage.

2. Cornerstone anti-PD-L1 monoclonal antibody to be included in breakthrough treatment

The recombinant anti-PD-L1 human monoclonal antibody injection, a class 1 biological new drug of cornerstone pharmaceutical, is proposed to be included in the breakthrough treatment. The proposed indication is relapsed or refractory extranodal natural killer cell / T-cell lymphoma (R / R enktl). According to public information, this recombinant anti-PD-L1 human monoclonal antibody injection, code named cs1001 (shuglizumab), has been approved by the US FDA as a breakthrough therapy in October 2020 for the monotherapy of adult R / R enktl.

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