Hengrui Pharma's Recombinant Anti-Tumor Antibody Injection Receives NMPA Approval Application Submission

Stock News07-29

Jiangsu Hengrui Pharmaceuticals Co.,Ltd. (600276.SH) has announced that its subsidiary, Suzhou Shengdiya Biopharmaceuticals Co., Ltd., has received an Acceptance Notice from the National Medical Products Administration (NMPA).

The marketing authorization application for the company's injectable drug, Recombinant Humanized Anti-Tumor Necrosis Factor Receptor Superfamily Member 4 Monoclonal Antibody (SHR-A2009), has been formally accepted by the NMPA.

The proposed indication is for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed following treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) and whose tumors harbor an EGFR gene mutation.

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