SBP GROUP (01177.HK): New Indication of Benmelstobart plus Chemotherapy Sequentially with Anlotinib as First-Line Treatment for Squamous NSCLC Approved for Marketing

NewTimeSpace News: Sino Biopharmaceutical Limited (stock code: 01177) announced on August 7 that benmelstobart injection (trade name: Andevi), a Class 1 innovative drug independently developed by the Group's subsidiary Chia Tai Tianqing Pharmaceutical Group Co., Ltd., in combination with chemotherapy and sequentially combined with anlotinib hydrochloride capsules (trade name: Focovi), has been granted marketing approval by the National Medical Products Administration (NMPA) of China for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC). This is the 12th approved indication for anlotinib and the 6th approved indication for benmelstobart.

The approval was based on positive results from a randomized, double-blind, parallel-controlled, multicenter Phase III clinical trial (ETER700). The median progression-free survival (PFS) of the experimental group (benmelstobart plus paclitaxel and carboplatin, sequentially followed by anlotinib plus benmelstobart) was 11.20 months, compared with 8.28 months for the control group (tislelizumab plus paclitaxel and carboplatin), with a hazard ratio (HR) of 0.68 (95% CI: 0.53-0.88, P=0.0026), representing a 32% reduction in the risk of disease progression or death, and the study met its primary endpoint. The median overall survival (OS) of the experimental group has not been reached, compared with 26.45 months for the control group, with an HR of 0.75 (95% CI: 0.59-0.96, P=0.0199), demonstrating significant OS benefit.

In addition to the significant PFS improvement, the objective response rate (ORR) of the experimental group was 76.33%, higher than the control group's 71.78%; and the median duration of response (DoR) was 13.14 months, significantly longer than the control group's 11.07 months. Subgroup analyses showed consistent PFS benefit across nearly all clinical subgroups, covering patients with different ages, ECOG PS scores and PD-L1 expression levels. In terms of safety, no new safety signals were identified for the anlotinib combination regimen, and the rate of any discontinuation due to adverse events was 8.8% in the experimental group, slightly lower than 9.8% in the control group.

According to the announcement, anlotinib in combination with benmelstobart is the world's first first-line sq-NSCLC treatment combination to demonstrate superiority over the standard "immunotherapy plus chemotherapy" regimen in a head-to-head Phase III study. The study design, which sequentially adds the multi-target anti-angiogenic agent anlotinib after "immunotherapy plus chemotherapy" induction, validates a new maintenance treatment model of "immunotherapy plus anti-angiogenesis" dual-target synergy, providing strong evidence for improving long-term efficacy of first-line treatment and potentially helping more patients achieve longer survival benefits.

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