Fuhong Henlius submits an application for new indications of anti-PD-1 monoclonal antibody

Text|Pharmaceutical Mission Hills

On September 16, the Center for Drug Evaluation (CDE) of the National Food and Drug Administration of China announced that Fuhong Henlius had submitted a new indication application for the anti-PD-1 monoclonal antibody slulimumab injection and was accepted

Screenshot source: CDE official website

Slulimumab (HLX10) is an innovative anti-PD-1 monoclonal antibody developed by Fuhong Henlius.

At present, slulimumab is carrying out a number of clinical studies of single drugs and combination therapies around the world, including slulimumab + chemotherapy, slulimumab + HLX04 (recombinant anti-VEGF humanized monoclonal antibody injection) , Slulimumab + HLX07 (EGFR inhibitor) and other combined programs

According to the official website of Fuhong Hanliu, slulimumab combined with chemotherapy drugs is expected to be used for metastatic squamous esophageal epithelial cancer (ESCC), squamous non-small cell lung cancer, extensive-stage small cell lung cancer (ES-SCLC), and new gastric cancer.

According to the performance report of Henlius in the first half of 2021, the first-line global multi-center phase 3 clinical trial of slulimumab combined with chemotherapy (carboplatin-albumin paclitaxel) in the treatment of locally advanced or metastatic squamous non-small cell lung cancer has been completed The subjects were recruited into the group, and Henlius plans to submit an NDA to the NMPA for this indication in the second half of 2021

Reference materials:

[1] Drug Evaluation Center of China National Medical Products Administration.