Hengrui Pharma: Resubmitted Camrelizumab Injection Combination Therapy Application Accepted by FDA

Deep News02-03 21:22

Hengrui Pharma recently announced that the company has received a "Notification Letter" from the U.S. Food and Drug Administration (FDA) confirming that its resubmitted Biologics License Application for the combination therapy of Camrelizumab for Injection and Apatinib Mesylate Tablets as a first-line treatment for patients with unresectable or metastatic hepatocellular carcinoma has been accepted for review by the FDA. The announcement mentioned that several PD-1 monoclonal antibodies have been approved for marketing overseas, including Pembrolizumab (Merck & Co., brand name Keytruda), Nivolumab (Bristol Myers Squibb, brand name Opdivo), Cemiplimab (Regeneron Pharmaceuticals, brand name Libtayo), and Dostarlimab (GSK, brand name Jemperli). Multiple similar products have also been approved for marketing in China. According to a query of the EvaluatePharma database, the total global sales of anti-PD-1 antibodies in 2024 reached approximately $41.546 billion. As of now, the cumulative R&D investment in projects related to Camrelizumab for Injection amounts to approximately 31,974 million yuan (unaudited).

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