Bristol Myers Squibb Submits NDA for Ipilimumab Injection (YERVOY), the First CTLA-4 Inhibitor, in China

Original: winter

On December 26, the marketing application for "ipilimumab injection" (YERVOY) submitted by Bristol-Myers Squibb (BMS) was accepted by the Center for Drug Evaluation (Acceptance Number: JXSS1900071). YERVOY is the first CTLA-4 monoclonal antibody approved by the U.S. FDA worldwide for the treatment of melanoma.

Ipilimumab (YERVOY) is a monoclonal antibody targeting cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). It was approved by the FDA in April 2011 for the treatment of unresectable or metastatic melanoma. Subsequently, it received additional FDA approvals for new indications in advanced renal cell carcinoma and metastatic colorectal cancer.

According to the Insight Global New Drug Database (https://db.dxy.cn/v5/globalnewdrug), YERVOY is being developed for 28 indications, among which the application for marketing approval for non-small cell lung cancer has already been submitted.

According to the Insight database, Bristol-Myers Squibb (BMS) has conducted 13 clinical trials in China, covering multiple indications such as melanoma, small cell lung cancer, non-small cell lung cancer, pleural mesothelioma, and urothelial carcinoma. In addition to monotherapy and combination with chemotherapy, most regimens involve combination with the PD-1 monoclonal antibody nivolumab. Among these, Phase III clinical trials for small cell lung cancer and non-small cell lung cancer have been completed, and patient enrollment for advanced melanoma was completed in 2017.

Original Title: Bristol-Myers Squibb’s “Ipilimumab Injection” Submitted for Marketing Approval in China