Jiangsu Hengrui Pharmaceuticals (01276) received a complete reply letter regarding the injection of Carerizumab.
Hengrui Pharmaceutical (01276) announced that Jiangsu Hengrui Pharmaceutical Co., Ltd. (referred to as "the Company") recently received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application for camrelizumab in combination with apatinib mesylate tablets for the first-line treatment of unresectable or metastatic hepatocellular carcinoma patients.
Jiangsu Hengrui Pharmaceuticals (01276) announced recently that they have received a Complete Response Letter (CRL) from the Food and Drug Administration (FDA) regarding their Biologics License Application for the use of camrelizumab in combination with apatinib mesylate tablets for first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma. The feedback from the FDA mainly relates to observations during a CGMP inspection of the apatinib production facility in April 2026. The company has carefully evaluated the feedback and is taking steps to implement necessary improvements. The related facility had passed an inspection by the European Union in 2025. The CRL does not raise concerns about the clinical trial data, safety, or efficacy of the product. The company will be closely communicating with the FDA and partner Elevar Therapeutics to clarify the next steps in the application process.
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