SBP Group (01177) has announced that its subsidiary, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., has received marketing approval from China's National Medical Products Administration (NMPA) for the combination of its independently developed Class 1 innovative drug, Benmelstobart Injection (brand name: Andywell), combined with chemotherapy, followed by sequential use of Anlotinib Hydrochloride Capsules (brand name: Fukevel), for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC).
This marks the 12th approved indication for Anlotinib and the 6th for Benmelstobart. The approval is based on positive results from a randomized, double-blind, parallel-controlled, multicenter Phase III clinical trial (ETER700). The study evaluated the efficacy and safety of Benmelstobart combined with paclitaxel and carboplatin, followed by sequential Anlotinib plus Benmelstobart (experimental group), compared to Tislelizumab combined with paclitaxel and carboplatin (control group), for the first-line treatment of sq-NSCLC.
Results showed that the Anlotinib-based combination demonstrated significant and clinically meaningful improvements across multiple endpoint measures compared to existing standard treatment regimens.