International, Junshi Biology is serious! pd1 filed for listing in Europe

On November 15, 2022, the company announced that it had submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for riprilizumab for:

Triprilizumab in combination with cisplatin and gemcitabine as first-line therapy for patients with locally relapsed or metastatic nasopharyngeal carcinoma (NPC);

Triprilizumab in combination with paclitaxel and cisplatin is the first-line therapy for patients with unresectable locally advanced/relapsed or metastatic esophageal squamous cell carcinoma (ESCC).

This is after China and the United States, the global commercial layout of Riplelimab began to expand to Europe.

Previously, in July 2022, the FDA reaccepted the BLA application for the relapsed or metastatic nasopharyngeal carcinoma indication with a PDUFA date of December 23, 2022. If approved, triprilizumab will become the first and only tumor immunotherapy for the treatment of nasopharyngeal carcinoma in the United States.

On November 11, the Joint Prevention and Control Mechanism Comprehensive Team of The State Council issued the Notice on Further Optimizing the Prevention and Control Measures of the Novel Coronavirus Outbreak in a scientific and precise manner. For important inbound business personnel and sports groups, "point-to-point" transport was made to the closed-loop management area without quarantine (" closed-loop bubble "). Carry out business, training, competition and other activities, during the code management, do not leave the management area. Chinese personnel should be vaccinated against COVID-19 before entering the management area, and quarantine management or health monitoring measures should be taken according to the risk.

This will help Junsil complete the FDA's on-site inspection. The sea is just around the corner.