Boan Biotech Completes First Patient Dosing in Phase Ⅲ Clinical Trial for LY09004, Multiple R&D Projects Under Intensive Development

Luye Pharma Group today announced that Shandong Boan Biotechnology Co. Ltd. (Boan Biotech) has completed the first patient dosing in the phase Ⅲ clinical trial for LY09004 in China. As a key area for research and development, Luye Pharma is making great strides in its global R&D strategy for biopharmaceuticals through Boan Biotech, with multiple R&D projects under intensive development.

Partner with Ocumension to Meet Urgent Clinical Needs of Ophthalmic Patients

LY09004 is a recombinant human vascular endothelial growth factor receptor antibody fusion protein ophthalmic injection (strength 11.12mg(0.278ml)/vial). As a biosimilar to Eylea® (Aflibercept), LY09004 is indicated for the treatment of patients with neovascular wAMD, macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR). As a soluble decoy receptor, LY09004 can bind to cytokines such as VEGF-A, VEGF-B and P1GF, inhibit the downstream signaling pathway of VEGFR, inhibit neovascularization, and reduce vascular permeability, thereby treating pathological neovascularization of the retina and choroid eye diseases.

The head-to-head comparison of LY09004 to Eylea® shows a high degree of similarity in both physical and chemical properties and biological activities. The results of phase I clinical trials showed that LY09004 has a good safety and tolerability profile with no serious adverse reactions. As of the date of this announcement, the plan for the phase III clinical trial of LY09004 is a randomized, double-blind, parallel-controlled and multicenter clinical trial to compare the efficacy and safety of LY09004 to Eylea® (Aflibercept intraocular injection solution) in the treatment of wAMD.

At present, China has a large number of patients suffering from eye diseases, among which, wAMD, RVO, DME and other conditions have become the leading causes of blindness. The growing prevalence of these diseases is expected to exacerbate as the aging population grows, both in China and worldwide. Driven by this patient need, IQVIA data reports that sales of Eylea® in China in 2019 reached to RMB 74.34 million, with the product available in China since June 2018. In addition, global sales of the product reached US$7.542 billion in 2019, up 12% year-on-year.

In order to accelerate the clinical study and commercialization process for LY09004, Boan Biotech has entered into an agreement covering collaboration and exclusive promotion with Ocumension Therapeutics (Zhejiang) Co. Ltd. (Ocumension) – a subsidiary of Ocumension Therapeutics ¬– to co-develop LY09004 for its phase Ⅲ clinical study on the Chinese mainland. Ocumension has also been granted exclusive rights to develop and commercialize LY09004 on the Chinese mainland.

As a well-known company specialized in ophthalmology, Ocumension has a professional team and extensive operations experience. The collaboration will integrate the strengths of both parties and help to meet the urgent clinical needs of Chinese patients. In addition to the Chinese market, Boan Biotech will continue to develop this drug candidate in major global pharmaceutical markets including the U.S., Japan, Europe, and other countries and regions.

Accelerate Global Development of Biopharmaceutical Drugs

Boan Biotech’s antibody discovery work is based on four technology platforms: Human Antibody Transgenic Mouse and Phage Display Technology, Bispecific T-cell Engager Technology, ADC Technology, and Nanobody Platform. Boan Biotech’s efficient internal innovation capability enables it to conduct intensive development of multiple innovative antibody and biosimilar projects.

In the field of innovative antibodies, in January 2021, Boan Biotech announced that all subjects have been enrolled for the phase I clinical trial in China for LY-CovMab. Outside China, Boan Biotech will also carry out clinical trials in the United States. LY-CovMab employs a special design for the Fc region, which can avoid or reduce ADE and the exacerbation of cytokine storm. This improves the safety profile of the antibody drug candidate and increases the prospects of its final approval.

In the field of biosimilars, in January 2021, Boan Biotech also administered the final doses in the phase Ⅲ clinical trial for LY06006 (biosimilar to Prolia®) in China, with phaseⅠclinical trials ongoing in EU and the U.S.. In addition, a Biologic License Application has been submitted for LY01008 (biosimilar to Avastin®) in China, and LY01011 (biosimilar to Xgeva®) is undergoing phase III clinical trials in China.

It is also worthy of note that in just one month from December 2020, Boan Biotech received approximately RMB 877 million from a number of investors. The capital raised will help Boan Biotech accelerate the clinical development of its innovative antibody and biosimilar products, enhancing its competitive strengths and facilitating rapid, stable growth. The Boan Biotech pipeline now has more than 10 innovative antibodies with international intellectual property protection and 8 biosimilar products.