Luye Pharma Starts a Phase III Clinical Study for Denosumab Injection (LY01011) in China, Clinical trials of the drug in Europe and the United States achieve smooth progress

Luye Pharma Group announced that Denosumab Injection (LY01011), a biosimilar of Xgeva® developed by Shandong Boan Biotechnology Co. Ltd. (Boan Biotech), a subsidiary of the Group, has started a comparative clinical study (a Phase III clinical study) in China. The clinical trials of the drug in Europe and the U.S. are also under way and progressing well.

LY01011 is indicated for the following after receiving market approval:
• prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors,
• treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity,
• treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy.

The industry is generally optimistic about the market prospects of Xgeva®. The drug has been approved by the U.S. Food and Drug Administration (FDA) in November 2010, the European Medicines Agency (EMA) in July 2011, and the National Medical Products Administration in May 2019. According to public financial reports, Xgeva® achieved global sales of US$1.94 billion in 2019, growing 8.3% YoY.

Through efficient and innovative in-house capabilities, Boan Biotech has developed more than 10 innovative antibody products with international intellectual property protection, one of which is undergoing phase I clinical trials in China. Among biosimilar products, in addition to LY01011, the marketing authorization application for LY01008 (a biosimilar of Avastin®) was accepted by the China Center for Drug Evaluation of the National Medical Products Administration in April 2020; LY06006 (a biosimilar of Prolia®) is undergoing a comparative clinical study in China and Phase I clinical trials in the U.S. and Europe; LY09004 (a biosimilar of Eylea®) is undergoing a comparative clinical study in China.

Luye Pharma Group is increasing its investment into biopharmaceutical R&D and accelerating the development of its biopharmaceutical business through Boan Biotech, always remaining committed to providing high quality, innovative products to patients in China and worldwide. Boan Biotech currently boasts a series of novel antibody products and biosimilar drugs at various different clinical stages, and has established a complete industry chain covering R&D, manufacturing and commercialization in the field of biopharmaceuticals.

A senior spokesperson from Luye Pharma Group said: "Our company is actively pursuing technological transformation and upgrading. We will further increase investments, expand our biologics portfolio, and accelerate the launch of various products in our pipeline. We are looking forward to benefiting more patients in China and around the world by providing high-quality and affordable biologic antibody products."

To read more Press Release articles, click here.