The re-submission of the biopharmaceutical licensing application for Camrelizumab for injection was accepted by FDA.
2026-11-04 17:00:10
According to CoinMeta, Hengrui Medicine announced that the company has received a "Confirmation Letter" from the US Food and Drug Administration (hereinafter referred to as "FDA"). The company's resubmitted biologic product licensing application for Camrelizumab for injection in combination with Apatinib Mesylate Tablets for the first-line treatment of unresectable or metastatic hepatocellular carcinoma has been accepted by the FDA. Under the Prescription Drug User Fee Act, the FDA's target review date for Camrelizumab for injection is April 9, 2027. To date, the cumulative R&D investment in the Camrelizumab for injection project is approximately 3.533 billion yuan (unaudited).
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Source:Jin10 Data
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