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Marketing Authorization Application for Luye Pharma's Denosumab Injection Accepted in China

2021 / 10 / 14 Publisher:Luye Life Sciences Group

October 13, 2021, Shanghai -- Luye Pharma Group announced that the marketing authorization application for the Denosumab Injection (LY06006 / BA6101), developed by Boan Biotech, a subsidiary of the Group, has been accepted by the Center for Drug Evaluation of China's National Medical Products Administration (NMPA).

LY06006/BA6101, a biosimilar to Prolia® is a fully human IgG2 monoclonal antibody. Denosumab prevents RANKL from activating RANK, an osteoclast precursor's receptor. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and cancellous bone.

The originator Denosumab Injection Prolia® has been approved around the world for the following indications: 1. treatment of postmenopausal women with osteoporosis at high risk of fracture; 2. treatment for increasing bone mass in men with osteoporosis at high risk of fracture; 3. treatment for glucocorticoid-induced osteoporosis in men and women at high risk of fracture; 4. treatment for increasing bone mass in men receiving androgen deprivation therapy for nonmetastatic prostate cancer at high risk of fracture; and 5. treatment for increasing bone mass in women receiving adjuvant aromatase inhibitor therapy for breast cancer at high risk for fracture.

Denosumab Injection has broad market potential globally. According to public financial reports, global sales of Prolia® totaled USD 2.76 billion in 2020. In June 2020, Prolia® was approved by NMPA to launch in China.

Being in the marketing authorization application phase in China puts LY06006/BA6101 alongside leading domestic players, meanwhile, phase I clinical trials of the drug in Europe and the U.S. are progressing well. In addition to these markets, Boan Biotech also plans to register LY06006/BA6101 in other countries and regions around the world.

Boan Biotech is building a differentiated and diverse product portfolio, covering biosimilars, innovative antibodies and cell therapies. The company's R&D pipeline now includes more than ten innovative antibodies with international intellectual property protection, with a number of biosimilars under development. Boan Biotech is accelerating the development of its biopharmaceutical business worldwide in order to provide high-quality innovative bio-antibody products to patients with unmet treatment needs.

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