The board of directors (the "Board") of Sino Biopharmaceutical Limited announces that the Phase III clinical trial of the Group's Category I antitumor innovative drug TQB2450 Injection in combination with Anlotinib Hydrochloride Capsules for the first-line treatment of small cell lung cancer ("SCLC") has completed its interim analysis and reached the pre-defined end point of the protocol as reviewed by the Independent Data Monitoring Committee (IDMC). The Group has recently submitted a new drug marketing application to the Center for Drug Evaluation (CDE) of the National Medical Products Administration of the People's Republic of China and the application has been accepted. Lung cancer is a malignant tumour with high incidence and mortality rates worldwide, and SCLC accounts for 15-20% of all lung cancers.

SCLC is very different from non-small cell lung cancer in terms of tissue origin, biological characteristics, response to treatment and prognosis, etc. It is more aggressive and has a poorer prognosis, with a 5-year survival rate of less than 5%. On 29 August 2019, the National Medical Products Administration approved the use of Anlotinib Hydrochloride Capsules as a single drug for the treatment of patients with small cell lung cancer who have progressed or relapsed after receiving at least two previous systemic chemotherapy.

TQB2450 Injection is a humanized PD- L1 monoclonal antibody 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 TQB2450 injection in combination with Anlotinib Hydrochloride Capsules 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.). TQB2450 Injection is another Category I innovative drug recently submitted by the Group after TQ-B3139 and TQ-B3101 Capsules.

The Group has been making breakthroughs in the research and development of innovative drugs and its new drug pipeline has gradually entered the harvesting phase.