Boan Biotech Obtains Approval for Initiating Clinical Trial for Nivolumab Injection (LY01015) in China

Luye Pharma Group today announced that Nivolumab injection (LY01015) developed by the Group's holding subsidiary Boan Biotech, has obtained the approval from the China’s National Medical Products Administration to initiate clinical trials.

As the first biosimilar to Opdivo^® approved for clinical trials according to Registration Classification 3.3 of Biological Product, LY01015 is used for the treatment of patients with Melanoma, Non-Small Cell Lung Cancer, Malignant Pleural Mesothelioma, Renal Cell Carcinoma, Classical Hodgkin Lymphoma, Squamous Cell Carcinoma of the Head and Neck, Urothelial Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma, Esophageal Squamous Cell Carcinoma and Advanced Gastric or Gastroesophageal Junction Cancer.

Immuno-oncology represented by PD-1 inhibitors has become one of the main therapies for cancer throughout the world. A PD-1 inhibitor resists cancer cells by activating the autoimmune system. It achieves this by blocking the pathway through which cancer cells induce the dormancy of human immune cells (T-cells), so as to partially restore the ability of T-cells to kill cancer cells. As a result, it succeeds in controlling or eliminating cancer on a long-term basis, and provides hopes of a cure for cancer.

As the world's first PD-1 immune checkpoint inhibitor approved by the regulators, the Nivolumab Injection has become a key option for treating multiple types of cancers, with over ten indications globally. Publicly available financial data shows that the worldwide sales of Opdivo^® (the reference drug for LY01015) reached USD 7.204 billion in 2019, growing 7.0% YoY. In addition to the market in China, Boan Biotech is also planning to register LY01015 in other countries and regions.

Luye Pharma is increasing its investment into biopharmaceutical R&D and accelerating the worldwide development of its biopharmaceutical business through Boan Biotech. Boan Biotech already has a product portfolio consisting of more than 10 innovative antibodies protected by international intellectual property rights and 8 biosimilars, and is actively expanding in areas involving cutting-edge technologies such as cell therapy. In relation to biosimilar products, apart from LY01015, LY01008 (a biosimilar of Avastin^®) is expected to be approved for marketing in China soon; LY06006 (a biosimilar of Prolia^®) and LY01011 (a biosimilar of Xgeva^®) are under phase III clinical trials in China and phase I clinical trials in Europe as well as the United States; LY09004 (a biosimilar of Eylea^®) is under phase III clinical trial in China. In addition, one of its innovative antibody products, LY-CovMab for neutralizing SARS-CoV-2 has completed phase I clinical trial in China.