Sichuan Kelun-Biotech Biopharmaceutical (HKG:6990) said its new drug application (NDA) for its cancer drug was approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China based on the positive results from the pivotal phase III, according to a Thursday filing with the Hong Kong bourse.
Sacituzumab Tirumotecan treats adult patients with epidermal growth factor receptor (EGFR)-mutant locally advanced or metastatic non-small cell lung cancer (NSCLC) with progression after treatment with EGFR-tyrosine kinase inhibitor (TKI) therapy, the filing said.
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