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China Biopharmaceutical (01177): New indications for first-line treatment of squamous non-small cell lung cancer with bemosubizumab combined with sequential chemotherapy combined with anlotinib were approved for marketing
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Zhitong Finance App News, China Biopharmaceutical (01177) issued an announcement. The group's subsidiary, Zhengda Tianqing Pharmaceutical Group Co., Ltd. (Zhengda Tianqing), a national class 1 innovative drug, bemosubizumab injection (trade name: Andevil®) combined with sequential chemotherapy plus anrotinib hydrochloride capsules (trade name: Fukowei®) has obtained marketing approval from China National Drug Administration (NMPA) for first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer ( sq-nsclc). This is the 12th indication approved for anlotinib and the 6th indication approved for bemosubizumab.

The approval was based on the positive results of a randomized, double-blind, parallel-controlled, multicenter phase III clinical trial (ETER700). The purpose of this study was to evaluate the efficacy and safety of bemosubizumab in combination with paclitaxel and carboplatin, sequentially followed by anlotinib combined with bemosubimab (test group) to compare tiralizumab combined with paclitaxel and carboplatin (control group) for first-line treatment of Sq-nsCLC. The results showed that compared with existing standard treatment plans, the anlotinib combination showed significant and clinically significant improvements in multiple endpoint indicators.

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