PK Hengrui! New indication of Merck's PD-1 monoclonal antibody Keytruda esophageal cancer is about to be approved in China

• Recently, the marketing application (JXSS1900044) of Merck's PD-1 monoclonal antibody pabolizumab (Trade Name: Keytruda, commonly known as "the K drug") in NMPA has been changed to "under approval", with a high probability Approved this month. The indication is a second-line treatment for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have failed in previous first-line systemic treatment. If successfully approved, it will be the 5th indication for K drug approved in China.
• On the same day, Hengrui's PD-1 monoclonal antibody Carrizumab's marketing application(CXSS1900034, 35) for new indication was also changed to "under approval", respectively second-line medicine for advanced esophageal squamous cell carcinoma, combined with pemetrexed and carboplatin for the first-line treatment of advanced or metastatic non-squamous cell non-small cell lung cancer.
• In July of 2019, the FDA approved K drug for the first-line treatment of locally advanced or metastatic esophageal squamous cell carcinoma with positive PD-L1 expression (CPS ≥ 10), which became the world's first approved PD-L 1 mAb.
• There are 6 PD-1 monoclonal antibodies approved in China at the moment, including 2 imported ones, and 4 Chinese produced ones. Among these, only Sintilimab was successfully included into the 2019 National Medical Insurance. Among the 6 monoclonal antibodies, the K drug shares the highest sales, marked ten-billion dollars of sales for the first time in 2019, O drugs ranked second, and 2019 sales have just exceeded 8 billion dollars. Among the 4 Chinese PD-1 monoclonal antibodies, Tislelizumab was not approved for marketing in 2019 due to the late approval. Sales of Toripalimab and Sintilimab in 2019 are 774 million RMB and 1.016 billion RMB respectively. It is estimated that sales of Camrelizumab in 2019 will be one billion RMB.

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