AstraZeneca's PD-L1 Inhibitor Durvalumab (Imfinzi) Receives CDE Acceptance for New Indication in China

On September 8, the CDE website showed that AstraZeneca's durvalumab (Imfinzi) new indication marketing application was accepted. This is the fourth indication of durvalumab for marketing application in China.

Durvalumab is a humanized PD-L1 monoclonal antibody that blocks the binding of PD-L1 to PD-1 and CD80, thereby preventing tumor immune escape and lifting the suppression of immune responses.

Currently, Durvalumab has been approved for 5 indications globally, covering non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, urothelial carcinoma, and biliary tract cancer. Among them, the two indications for non-small cell lung cancer and small cell lung cancer have been approved in China. In March this year, the marketing application of Durvalumab combined with chemotherapy for first-line treatment of locally advanced or metastatic biliary tract cancer has been accepted by the CDE.

As part of the overall development plan, durvalumab is currently being explored as monotherapy or in combination with other anticancer agents for the treatment potential in small cell lung cancer, non-small cell lung cancer, bladder cancer, various gastrointestinal (GI) cancers, ovarian cancer, endometrial cancer, and other solid tumors.

According to AstraZeneca's financial report, the revenue of Durvalumab in the first half of this year was 1.976 billion US dollars, increasing by 57%.

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