Luye Pharma : World’s First Denosumab Biosimilar Boyoubei® Launched in China

- Accelerating the availability of this quality biologic for osteoporosis patients -

Shanghai, December 10, 2022 - Boan Biotech, a subsidiary of Luye Pharma Group, today held an offline product launch conference in Shanghai, together with an online event, to announce the launch of Denosumab Injection (Boyoubei^®) in China. Indicated for the treatment of osteoporosis in postmenopausal women at high risk of fractures, the drug can significantly reduce patients' risk of vertebral, non-vertebral and hip fractures. Boyoubei^® is the first denosumab biosimilar approved for marketing in the world, and its launch represents a milestone in the high-quality development of China's biopharmaceutical industry. In addition to China, Boan Biotech is also developing Boyoubei^® in Europe and the U.S., with plans to market the drug globally.

Medical experts in attendance at the launch event included Professor Zhang Zhenlin from the Sixth People's Hospital of Shanghai Jiao Tong University, Professor Ding Yue from Sun Yat-sen Memorial Hospital, Professor Xu Jin from Shandong Provincial Hospital, Professor Yue Hua from the Sixth People's Hospital of Shanghai Jiao Tong University and Professor Xue Qingyun from Beijing Hospital. Also in attendance were Boan Biotech executives Jiang Hua, Chairlady and Chief Executive Officer, Dr. Dou Changlin, R&D President and Chief Operating Officer and Lu Jun, Senior Vice President of Bioengineering Center and Head of Quality, among others. Discussions were held covering industry hot topics, such as the status quo and future of osteoporosis treatment, strategies for diagnosis and treatment and medications used in practice, to better help maximize the clinical benefits for osteoporosis patients.

Osteoporotic fractures are one of the main causes of disability and death in older patients

Osteoporosis is known as a "silent killer", because patients tend to ignore the early symptoms, and most seek diagnosis and treatment only after experiencing a resulting bone fracture (fragility fracture). Studies show that 32.1% of women over the age of 50 in China have osteoporosis, and for those over 65 the percentage is 51.6%. Many women do not realize they have osteoporosis until after suffering a fragility fracture of the wrist, vertebrae or hip, and such patients are five times more likely than average to have another fracture within one year.

Professor Zhang Zhenlin, Director of Osteoporosis and Bone Diseases, the Sixth People's Hospital of Shanghai Jiao Tong University, said: "Fragility fractures are one of the main causes of disability and death in older patients, imposing a heavy burden on patients and wider society. A hip fracture, in particular, is frequently called 'the ultimate fracture', as roughly 20% of osteoporosis patients who suffer a hip fracture will die from the various resulting complications, with 50% becoming disabled within one year. I'm excited to see the launch of Boyoubei^® as the world's first denosumab biosimilar. This high-quality drug provides a new treatment option for osteoporosis patients and addresses their clinical needs."

Professor Ding Yue from Sun Yat-sen Memorial Hospital and Professor Xu Jin from Shandong Provincial Hospital congratulated Boan Biotech on the launch of Boyoubei^® via video conference, both conveying their high expectations for the drug.

A local biosimilar developed in accordance with international quality standards

Internationally, denosumab is a first-line treatment for osteoporosis. The drug has been recommended by a number of treatment guidelines both in China and abroad for its ability to inhibit bone resorption, increase bone density, prevent and treat osteoporosis, and to lower the risk of bone fractures. Boyoubei^® was developed in accordance with guidelines for the research and development of biosimilars, demonstrating a high biosimilarity to the reference product in quality, safety, and effectiveness.

The Phase III clinical trial for Boyoubei^® took place across nearly 50 of China's Grade III Class A hospitals. Professor Yue Hua, Associate Director of Osteoporosis and Bone Diseases, the Sixth People's Hospital of Shanghai Jiao Tong University, explained in detail the results of the clinical study, saying: "Boyoubei^® demonstrated good efficacy and safety in the clinical study. After being treated with Boyoubei^® for six months or one year, postmenopausal women with osteoporosis at high risk of fractures showed a significantly higher bone mineral density (BMD) in their lumbar spine, hip and femoral neck, as well as significantly lower levels of biochemical markers for bone turnover, including C-terminal telopeptide of type I collagen(CTX) and procollagen type 1 N-peptide (P1NP). The launch of Boyoubei® provides more treatment options for patients in need of this class of drugs."

Dr. Dou Changlin, R&D President and Chief Operating Officer of Boan Biotech, said: "Boyoubei^® was launched as China's first locally developed denosumab injection thanks to the strong CMC and overall R&D management capabilities of Boan Biotech. We used a series of step-by-step pharmaceutical, non-clinical, pharmacokinetic and clinical studies to rigorously and comprehensively validate the overall biosimilarity between Boyoubei® and the reference drug. Furthermore, we developed Boyoubei® in accordance with international quality standards, striving to achieve better with the aim of providing a high-quality, locally developed biosimilar for patients both in China and around the world."

Lu Jun, Senior Vice President of Bioengineering Center and Head of Quality of Boan Biotech, said: "We have in place a quality management system in accordance with the relevant standards of the U.S., the EU and China, and a manufacturing facility built with state-of-the art design, which sees continual upgrades. We are committed to serving patients by constantly improving our product quality and manufacturing efficiency."

Able to reduce the risk of fractures, denosumab is a first-line treatment for osteoporosis

Denosumab is a broad-spectrum drug for treating osteoporosis that has been in use outside of China for over a decade. As the only anti-RANKL monoclonal antibody for treating osteoporosis in China, 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, functioning and survival, thereby reducing bone resorption and increasing bone mass and strength in both the cortical bone and the cancellous bone.

Professor Xue Qingyun, Director of Orthopedics, Beijing Hospital, said in his keynote speech Advice of Chinese Experts on the Proper Use of Denosumab: "Denosumab provides a convenient, effective, and economical option for postmenopausal women suffering from osteoporosis. The drug is not metabolized by the kidney, moreover can be used continuously for over 10 years; both characteristics which indicate a good safety profile. Furthermore, it is administered subcutaneously via injection once every six months, making it very convenient for use in clinical practice."

After the keynote speech session, several experts in attendance held talks on industry hot topics such as the latest developments in the field of drugs for the treatment of osteoporosis and their clinical application, treatment strategies for perioperative patients, and the standard diagnosis and treatment for osteoporosis.

Increasing the availability of medications for osteoporosis patients

Osteoporosis has become an increasingly serious public health challenge in China due to its high prevalence and the danger of bone fractures associated with it. However, there are still many difficulties in addressing the disease, including low public awareness, a low diagnosis rate, and improper treatment adoption. Data shows that even after experiencing a fragility fracture (vertebral or hip), only about 2/3 of the patients will receive a diagnosis, and fewer than 1/4 of them will begin treatment with effective osteoporosis medications.

Jiang Hua, Chairlady and Chief Executive Officer of Boan Biotech, said: "At Boan Biotech, we're well-prepared to address the unmet needs in treating osteoporosis in terms of channel development, team building, market access, and patient education. Following its approval for launch, it took just 21 days to have Boyoubei^® prescribed for the first time in multiple hospitals across China. Now, the drug is available in 50 Chinese cities. We are committed to reducing the burden of disease on patients and wider society by providing quality drugs, and look forward with anticipation to working with various stakeholders to do more for preventing and treating osteoporosis in China."

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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 oncology, autoimmune diseases, ophthalmology, and metabolic diseases. 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 the EU.