BeiGene submits application for the fifth indication for Tislelizumab Injection

On June 29, the official website of CDE showed that the PD-1 antibody of BeiGene submitted a new indication application for Tislelizumab injection and was accepted. The new indication marketing application is the fifth application submitted for Tislelizumab in China and the second new indication marketing application submitted within the last week.

After the first approved indication for Hodgkin lymphoma, 4 new adaptations were submitted:

On April 11, 2020, Tislelizumab was approved for the treatment of urothelial carcinoma with locally advanced or metastatic PD-L1 high expression that failed to receive platinum-containing chemotherapy, including neoadjuvant or adjuvant chemotherapy that progressed within 12 months (UC) patients;

On April 21, 2020, the application for marketing of new indications for Tislelizumab for the treatment of patients with first-line advanced squamous non-small cell lung cancer was accepted;

On June 24, 2020, the application for listing of new indications for Tislelizumab for the treatment of first-line advanced non-squamous non-small cell lung cancer patients was accepted;

At the 2020 ASCO annual meeting, two studies of Tislelizumab for gastroesophageal adenocarcinoma and advanced squamous non-small cell lung cancer were unveiled in the form of posters. Among them, the application for marketing of new indications for the treatment of first-line advanced squamous non-small cell lung cancer with tislelizumab had been accepted by NMPA.

About  the Author:    

Xiaoyaowan, a pharmaceutical industry practitioner, a word carrier in the We-media era focusing on changes of the pharma industry.