SINO BIOPHARM (01177): Bevacizumab injection approved for maintenance treatment after radiotherapy and chemotherapy for non-small cell lung cancer.

Sino Biopharm (01177) announced that the Group's self-developed national Class 1 innovative drug, Bevopsu monoantibody (trade name: Andewei), has obtained approval from the China National Medical Products Administration (NMPA) for a new indication. It is used for the treatment of unresectable stage III non-small cell lung cancer (NSCLC) patients who have not shown disease progression after receiving platinum-based synchronous or sequential chemotherapy and do not carry known epidermal growth factor receptor (EGFR) sensitive mutations or anaplastic lymphoma kinase (ALK) rearrangements. This approval is based on the positive results of the R-ALPS study, which were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (#LBA8004). The study included locally advanced/unresectable stage III NSCLC patients who did not progress after synchronous/sequential chemotherapy, receiving either Bevopsu monoantibody or placebo consolidation treatment until disease progression, with the primary endpoint being progression-free survival (PFS) evaluated by blinded independent central review (BICR). The study results showed a median follow-up time of 19.4 months, with a median PFS of 9.69 months in the Bevopsu monoantibody group and 4.17 months in the placebo group (HR=0.53, 95% CI 0.39-0.72, p<0.0001), reducing the risk of disease progression or death by 47%. Subgroup analysis (smoking status, previous treatment as synchronous/sequential) showed consistent benefits across all subgroups with the intention-to-treat (ITT) population, demonstrating the wide applicability of this treatment regimen. Overall survival (OS) data are still immature, with no median OS reached yet, but the Bevopsu monoantibody group has shown a trend towards OS benefit. In terms of safety, the incidence of Grade 3 treatment-related adverse events (TRAEs) was 29.4% in the Bevopsu monoantibody group and 19.7% in the placebo group. Bevopsu monoantibody is the third approved PD-L1 inhibitor for consolidation treatment after radical radiochemotherapy for locally advanced/unresectable NSCLC in China. In the future, the Group will continue to focus on innovation in the field of lung cancer treatment, with a product pipeline covering multiple molecular subtypes and treatment scenarios, to help improve patient survival outcomes and warm more lives with health technology.