Hengrui Medicine has announced that its combination therapy, known as "Shuang Ai," has received another complete response letter (CRL) from the U.S. Food and Drug Administration (FDA). This marks the third delay in approval for the injectable camrelizumab combined with apatinib mesylate, intended for the first-line treatment of unresectable or metastatic hepatocellular carcinoma. The company stated that the CRL does not raise concerns about the product's clinical data, safety, or efficacy, and they remain confident in its long-term potential for liver cancer treatment. AI
RANK_REASON Regulatory action on a drug product.
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