The board of directors of Sino Biopharmaceutical Limited announced that the category 1 innovative drug Benmelstobart Injection "Benmelstobart self-developed by the Group has obtained approval for marketing from the National Medical Products Administration of China for use in first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC), in combination with Anlotinib Hydrochloride Capsules, carboplatin and etoposide. Benmelstobart is a humanized PD-L1 monoclonal antibody self-developed by the Group that blocks the binding of PD-L1 to PD-1 and B7.1 receptors on the surface of T cells, restoring T cell activity and thereby enhancing the immune response. Early clinical data have demonstrated that Benmelstobart in combination with Anlotinib have synergistic effects on a number of tumour types (e.g. non-small cell lung cancer, soft tissue sarcoma, renal cell carcinoma, endometrial cancer, ovarian cancer, hepatocellular carcinoma, cholangiocarcinoma, etc.).

The approval for the indication of first-line treatment for small cell lung cancer is based on a randomised, double blinded, placebo control, multicenter Phase III clinical trial of Benmelstobart in combination with Anlotinib, carboplatin and etoposide for the first-line treatment of small cell lung cancer (ETER701). ETER701 study results were presented at the 2023 World Conference on Lung Cancer (WCLC): As of 14 May 2022, the median progression-free survival (mPFS) was 6.9 months (95% CI: 6.18-8.25) and 4.2 months (95% CI: 4.17-4.24) in the Benmelstobart in combination with Anlotinib and chemotherapy group and chemotherapy-only group, respectively, and the risk of tumour recurrence was reduced by 68%, with a statistically significant difference. The median overall survival (mOS) was 19.3 months (95% CI: 14.23-NE) and 11.9 months (95% CI: 10.74-13.37) for the Benmelstobart in combination with Anlotinib and chemotherapy group and chemotherapy-only group, respectively, and the risk of death was reduced by 39%, with a statistically significant difference.

In terms of safety, there were no unanticipated serious adverse events, and the overall safety profile of Benmelstobart in combination with Anlotinib and chemotherapy for the first-line treatment of patients with ES-SCLC was manageable. Lung cancer is a malignant tumour with high incidence and mortality rates in China and worldwide, and small cell lung cancer (SCLC) accounts for 13-17% of all lung cancers. SCLC is different from non- small cell lung cancer.

It is more aggressive and has a poorer prognosis, with a 5-year survival rate of less than 5%, thus, there is urgent need for effective treatment modalities.