Luye Pharma has announced the acquisition of two investigational biological antibodies being developed by Shandong Boan Biological Technology Co., Ltd. Luye Pharma has a carefully formulated strategy to succeed in the field of biopharma, with R&D of the company’s other biological antibodies making good progress in China and abroad. Given the strategic priority of biopharma, Luye Pharma has been increasing R&D investment in this field, speeding up pipeline building for the company’s biopharmaceuticals globally and creating a sustainable development impetus for the future.
The two acquired investigational biological antibodies (LY01011 & LY09004) are both monoclonal antibody drugs. LY01011 is a recombinant anti-RANKL full-body monoclonal antibody injection, a biosimilar of Xgeva for the treatment of multiple myeloma and bone metastasis from solid tumors. The drug has received approval for clinical trials and will soon enter Phase I studies. A biosimilar of Eylea, LY09004 is a recombinant human vascular endothelial growth factor receptor-antibody fusion protein ophthalmic injection. The drug is indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) in Patients with Diabetic Macular Edema. The application for LY09004 clinical trials has been submitted to regulators.
Biopharma is an important segment of the global pharmaceutical industry and is a key driver of future growth. According to public data, from 2016 to 2022, the global biopharmaceutical market is expected to increase in size from US$202 billion to US$326 billion, with a compound annual growth rate of 8.3%. In China, biopharma has also become one of the fastest growing areas of the pharmaceutical industry. From 2012 to 2016, the compound annual growth rate of the biopharmaceutical market in China was 24.9%, while total sales revenue is expected to reach RMB 326.9 billion in 2021.
Luye Pharma’s management team is very optimistic about the future prospects of the two acquired drugs, given the strong performance of comparable drugs in the market. In 2017, global sales of Xgeva, LY01011's market comparable product, reached 1.575 billion US dollars, while global sales of Eylea, LY09004's market comparable product, reached 5.929 billion US dollars. From the company's strategic planning perspective, the addition of LY01011 will further help to expand the company’s oncology product portfolio, while LY09004 will assist the company’s efforts of developing in the field of ophthalmology treatment. LY09004 is expected to significantly improve visual acuity in patients with macular edema as well as improving secondary CRVO. The investigational drug is expected to be a widely used treatment among elderly patients with wet macular degeneration and diabetic macular edema (DME).
Luye Pharma started on its R&D journey into biotechnology drugs at home and abroad in 2017, establishing a biological antibody technology development platform. In the second half of the same year, Luye Pharma acquired two other antibody products, LY01008 (a biosimilar of Avastin) and LY06006 (a biosimilar of Prolia) from Shandong Boan Biological Technology Co., Ltd. Currently, the two drugs are in Phase III and Phase I clinical trials in China respectively, with developments progressing smoothly.
In addition to these, Luye Pharma has also leveraged external partnerships to accelerate the pace of development and delivery of new biopharmaceutical drugs. At the end of last year, Luye Pharma entered into an agreement with ABPRO, an integrated life sciences company at the forefront of synthetic biology, to jointly research, develop and commercialize novel bi-specific antibodies in the field of immuno-oncology. In the first quarter of this year, Luye Pharma entered into an agreement with Excel Biopharm LLC, a California biotech company, to collaborate on the discovery and development of therapeutic antibodies for next-generation immuno-oncology treatment.