LY09004 Approved for Clinical Trials in China, Luye Pharma Steps-up Global R&D Investment in Biopharma Medicines

Luye Pharma announced that the company has received approval from the National Medical Products Administration of China (NPMA) for its antibody drug LY09004 to start clinical trials in China. In addition to LY09004, Luye Pharma has a number of biopharmaceuticals that have entered various stages of clinical trials at home and abroad, with overall R&D making good progress.

With the biopharma business as one of its main development priorities, Luye Pharma will continue to increase R&D investment in the field globally, speeding up entry into overseas markets and adding new impetus to the company’s future business growth.

LY09004, a biosimilar for Eylea®, is a recombinant human vascular endothelial growth factor receptor-antibody fusion protein ophthalmic injection, indicated for 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, and visual impairment due to pathological myopia secondary to choroidal neovascularization(PM-CNV). According to public data, Eylea's global sales in 2018 reached 2.185 billion euros. Luye Pharma is very optimistic about the growth potential and market demand for this class of drugs.

Biopharma is now an important part and a key growth driver of the Chinese and global pharmaceutical industry. According to public data, from 2016 to 2022, the size of the global biopharmaceutical market is expected to increase from US$202 billion to US$326 billion, representing a compound annual growth rate of 8.3%. The size of the biopharmaceutical market in China is also expected to reach RMB 326.9 billion by 2021. In recent years, both macroeconomic policies and industry environments have been very favourable for the development of biopharma. To take full advantage of market opportunities, Luye Pharma has embarked on R&D projects into a number of biopharmaceuticals at home and abroad, as well as establishing a bio-antibody technology development platform. Development of these drugs is progressing well.

In addition to LY09004, the company has several other bio-antibody products in different stages of clinical development in China. LY01008, a recombinant humanized anti-VEGF monoclonal antibody injection (a biosimilar for Avastin) for the treatment of colorectal cancer and non-small cell lung cancer is in phase III trials. LY06006, a RANKL-specific recombinant fully human monoclonal antibody injection (a biosimilar for Prolia) for the treatment of osteoporosis in postmenopausal women is making good progress with phase I trials, while LY01011, another RANKL-specific recombinant fully human monoclonal antibody injection (a biosimilar for Xgeva) for the treatment of multiple myeloma and bone metastases induced by solid tumors has been approved to conduct clinical trials.

To continue the healthy expansion of its biopharma pipeline, Luye Pharma has also entered into partnerships with a number of leading overseas biopharmaceutical companies in R&D, including the development of a new bi-specific antibody for immuno-oncology with Abpro, a life science company in the field of synthetic biology, the development of therapeutic antibodies for next-generation immuno-oncology with the U.S.-based biotechnology company Excel, and the development of CAR-T therapy in collaboration with ELPIS.

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