Shanghai, November 10, 2022 – Luye Pharma Group today announced that Denosumab Injection (Boyoubei^®) developed by its subsidiary Boan Biotech has been approved for launch in China by the National Medical Products Administration (NMPA) for the treatment of postmenopausal women with osteoporosis at high risk of fractures. The drug can significantly reduce the risk of vertebral, non-vertebral and hip fractures within this patient segment. Boyoubei^® is the first biosimilar to Prolia^® (the originator of denosumab) approved for marketing in the world. In addition to China, Boyoubei^® is being developed in Europe and the U.S., with a plan to be marketed in the global markets. 

Comprehensive evidence shows that Boyoubei is bioequivalent to the originator drug

The active ingredient of Boyoubei^® is a fully human IgG2 anti-RANKL monoclonal antibody. The drug is administered subcutaneously once every six months. Denosumab is the first and only anti-RANKL monoclonal antibody for the treatment of osteoporosis in China. As a broad-spectrum anti-osteoporosis drug, it represents a powerful tool for decreasing bone resorption and increasing bone mass and strength, preventing osteoporosis and factures. 

The development of Boyoubei^® follows the relevant research guidelines of biosimilars, through a series of step-by-step pharmaceutical studies as well as studies on non-clinical, human pharmacokinetics and clinical effectiveness, which scientifically, rigorously and completely prove the overall similarity between Boyoubei^® and the originator reference drug: the quality, safety and efficacy of the two drugs are highly similar, and there is no clinically meaningful difference between them. The results of the two Phase I clinical studies of Boyoubei^® were published in Expert Opinion on Investigational Drugs¹ and Frontiers in Pharmacology², respectively, with those of the Phase III clinical study published in Journal of Orthopaedic Translation³. 

Professor Zhang Zhenlin, Director of the Osteoporosis and Bone Diseases Department, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University, led the Phase III clinical trial for Boyoubei^®. The study involved nearly 50 Grade III Class A hospitals in China. Professor Zhang said: “Boyoubei^® demonstrated excellent efficacy and safety in the clinical study. After being treated with Boyoubei^® for six months or one year, postmenopausal women at the high risk of developing osteoporosis showed significantly higher bone mineral density (BMD) in the lumbar spine, hip, and femoral neck, as well as significantly lower levels of biochemical markers of bone turnover, including C-terminal telopeptide of type I collagen (CTX) and procollagen type 1 N-peptide propeptide (P1NP). The approval of Boyoubei^® will increase the accessibility of such drugs and provide another high-quality treatment option for patients with osteoporosis.” 

Denosumab, a first-line treatment for osteoporosis

Osteoporosis is an age-related bone disease⁴ most common in postmenopausal women and older men. Studies show that China has 230 million women over the age of 50, and among these, 32.1% have osteoporosis⁵. The disease is called a “silent killer”, because its early symptoms are not obvious, and patients often do not seek treatment until experiencing a resulting bone fracture. Osteoporotic fractures are among the main causes of disability and death in older patients: within one year after having a hip fracture, around 20% of the patients will die from various complications and 50% will become disabled⁴, causing a serious burden to patients and society.

As a globally-recognized first-line treatment for osteoporosis, denosumab provides a convenient, effective, and economic option to postmenopausal women suffering from the disease. The drug prevents RANKL from activating RANK, a receptor on the surface of osteoclasts and osteoclast precursors. Preventing 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. Clinical evidence shows that denosumab can consistently increase BMD and reduce the risk of vertebral, non-vertebral and hip fractures in patients with osteoporosis, and can be used continuously for over 10 years, indicating its good safety profile.

Denosumab has been recommended by a number of treatment guidelines both in China and abroad, including Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis — 2020 Update by the American Association of Clinical Endocrinologists/American College of Endocrinology⁶, Pharmacological Management of Osteoporosis in Postmenopausal Women: An Endocrine Society Guideline Update by the Endocrine Society⁷, European Guidance for the Diagnosis and Management of Osteoporosis in Postmenopausal Women by the European Society for Clinical and Economic Aspects of Osteoporosis⁸, and Diagnosis and Treatment Guidelines for Primary Osteoporosis 2017 by the Chinese Society of Osteoporosis and Bone Mineral Research⁴.

A combination of factors such as the huge demand from patients and the high clinical value of the drug have created a large and rapidly growing market for denosumab. Publicly available information shows that global sales of Prolia^® totaled USD 3.248 billion in 2021, representing an 18% year-on-year increase. Furthermore, according to a Frost & Sullivan Report, the market for denosumab to treat osteoporosis in China is expected to grow to RMB 7.8 billion by 2030⁹. 

Dr. Dou Changlin, R&D President and Chief Operating Officer of Boan Biotech, said: “The approval of Boyoubei^® as the first denosumab injection developed by a Chinese company has further demonstrated the strong CMC development and overall R&D management capabilities of Boan Biotech. Our pipeline is centered on patient needs and driven by the clinical value and market potential of a candidate. In addition to China, we are also accelerating the overseas development of Boyoubei^®. We look forward to providing high-quality and affordable biosimilars for patients around the world.”

Boan Biotech is effectively driving the commercialization of more products

Boan Biotech is committed to developing, manufacturing and commercializing quality biologics in China and around the world. To date, the company has launched two products, and its pipeline includes a number of biosimilar candidates close to commercialization and multiple differentiated Class 1 innovative biologic candidates. With a strong portfolio, comprehensive biopharmaceutical platforms and increasingly sophisticated commercial capabilities, Boan Biotech has built a competitive edge unique to itself. 

Jiang Hua, Chairlady and Chief Executive Officer of Boan Biotech, said: "In 2021, we successfully launched our first product, Boyounuo^® (Bevacizumab Injection), and this year we again had our second product, Boyoubei^®, approved for launch. Thanks to our strength across the whole industrial chain, from research to manufacturing and commercialization, we have built up strong momentum to accelerate the launch of more investigational drugs. This enables our innovative products to reach a higher quality, achieve wider coverage, and benefit more patients faster. We are committed to contributing to China’s high-quality biopharmaceutical industry development, fulfilling the 'Healthy China' vision, and supporting the health and well-being of the general public."

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About Boan Biotech

As a subsidiary of Luye Pharma Group, Boan Biotech is a fully-integrated biopharmaceutical company that specializes in developing, manufacturing and commercializing therapeutic antibodies, with a focus on key therapeutic areas including oncology, autoimmune diseases, ophthalmology, and the metabolism. The company’s antibody discovery is based on three technology platforms: Human Antibody Transgenic Mouse and Phage Display Technology Platform, Bispecific T-cell Engager Technology Platform and ADC Technology Platform. Boan Biotech’s product portfolio currently includes two commercialized products, multiple investigational antibodies protected by international intellectual property rights, and a number of biosimilar candidates.

Boan Biotech operates across the entire value chain of the industry from antibody discovery, cell line development, upstream and downstream process development, analytical and bio-analytical method development, and technology transfer to pilot and commercial production. In addition to China, the company also conducts biopharmaceutical product development in the U.S. and EU.

References:

1. Wang S, Yang X, Huang J, et al. Pharmacokinetics, pharmacodynamics, safety, and immunogenicity of a biosimilar of denosumab (LY06006): a randomized, double-blind, single-dose, parallel-controlled clinical study in healthy Chinese subjects. Expert Opin Investig Drugs. 2022;31: 1133-1142. 
2. Niu S, Chen M, Yan D, et al. A Randomized Controlled Dose-Escalation Study of LY06006, a Recombinant Humanized Monoclonal Antibody to RANKL, in Chinese Healthy Adults. Frontiers in Pharmacology. 2022;13: 893166.
3. Gu J, Zhang H, Xue Q, et al. Denosumab biosimilar (LY06006) in Chinese postmenopausal osteoporotic women: A randomized, double-blind, placebo-controlled, multicenter phase III study. Journal of Orthopaedic Translation. 2023; 38: 117-125.
4. Chinese Society of Osteoporosis and Bone Mineral Research. Diagnosis and Treatment Guidelines for Primary Osteoporosis (2017). [J]. Chinese Journal of Osteoporosis and Bone Mineral Research, 2017, 10: 413-443. 
5. Chinese Society of Osteoporosis and Bone Mineral Research. Chinese Expert Recommendations on the Clinical Rational Use of Denosumab in Osteoporosis. [J]. Chinese Journal of Osteoporosis and Bone Mineral Research, 2020, 11: 499-508.
6. Camacho PM, Petak SM, Binkley N, et al. American Association of Clinical Endocrinologists/ American College of Endocrinology Clinical Practice Guidelines for the diagnosis and treatment of postmenopausal osteoporosis-2020 update [ J]. Endocr Pract, 2020,26: 1-46.
7. Shoback D, Rosen CJ, Black DM, et al. Pharmacological management of osteoporosis in postmenopausal women: an endocrine society guideline update [J]. J Clin Endocrinol Metab, 2020, 105: 587-594.
8. Kanis JA, Cooper C, Rizzoli R, et al. European guidance for the diagnosis and management of osteoporosis in postmenopausal women [J]. Osteoporos Int, 2019, 30: 3-44.
9. Frost & Sullivan Report