
On July 17, the CDE website showed that Bristol-Myers Squibb has submitted another new indication application for Nivolumab Injection in China, which has been accepted. Nivolumab is a PD-1 inhibitor that has previously been approved for 9 indications in China. Based on publicly available information, the new indication for this drug's current marketing application is speculated to be hepatocellular carcinoma.
Screenshot source: CDE official website
Nivolumab (Nivolumab) was first approved in July 2014, becoming the world's first approved PD-1 inhibitor. In China, nivolumab has previously been approved for 9 indications, covering non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma, gastric or gastroesophageal junction adenocarcinoma, non-epithelioid malignant pleural mesothelioma, advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma, esophageal squamous cell carcinoma, urothelial carcinoma, and multiple cancer types.According to public information, the new indication of Nivolumab submitted in China this time is speculated to be for liver cancer. According to the Insight database, Bristol-Myers Squibb has conducted multiple studies on Nivolumab for the treatment of hepatocellular carcinoma in mainland China, including:
Globally, since its initial approval in 2014, the number of approved indications for Nivolumab has continued to increase.To date, the drug has been approved for marketing in dozens of countries and regions worldwide, with indications covering lung cancer, head and neck cancer, gastric cancer, esophageal cancer, liver cancer, renal cancer, colorectal cancer, urothelial carcinoma, melanoma, Hodgkin's lymphoma, pleural tumors, and other cancers.Type。
Since its launch, the sales of Nivolumab have been on the rise, with global sales reaching $8.249 billion in 2022. In 2023, it maintained an upward trend, reaching $9.009 billion, remaining one of the main sources of revenue for Bristol-Myers Squibb.
Nivolumab Sales (2014 - 2023)
Image Source: Insight Database Web Version
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