Recently, Qilu Pharmaceutical's biosimilar Denosumab Injection (Lukexin) received marketing approval from the National Medical Products Administration for the treatment of osteoporosis in postmenopausal women at high risk of fractures. In postmenopausal women, this product significantly reduces the risk of vertebral, non-vertebral, and hip fractures. Against the backdrop of China's increasing aging population and the rising number of osteoporosis patients, the approval of Lukexin® provides a new treatment option for individuals with osteoporosis.
The anti-osteoporosis drug market is huge.
Osteoporosis is a systemic bone disease characterized by low bone mass, destruction of bone microstructure, leading to increased bone fragility and susceptibility to fractures, and is defined by the WHO as one of the top ten chronic diseases.The results of the 2018 epidemiological survey on osteoporosis in China conducted by the National Health Commission showed that the prevalence of primary osteoporosis among people aged 50 and above in China was 19.2%.The population aged 65 and above reaches 32.0%, of which 10.7% are male and 51.6% are female.China has more than 90 million patients with primary osteoporosis, making it the country with the largest number of osteoporosis patients.However, the awareness rate and diagnosis rate of osteoporosis are quite low.Pain caused by osteoporosis itself can reduce the quality of life for patients. Spinal deformities and fractures can lead to disability, restrict patient mobility, and result in an inability to perform daily self-care activities. This increases the incidence of pulmonary infections and bedsores, not only worsening the quality of life and mortality rates but also imposing a heavy economic burden on individuals, families, and society. The mortality rate within one year due to complications from hip fractures caused by osteoporosis reaches 30%-50%, surpassing many types of cancer, and is often referred to as "the last fracture of life."With the intensification of aging trends, and under the background of the "Healthy Bones" special action in the Healthy China 2030 Planning Outline, osteoporosis will increasingly draw people's attention, and the potential market size for denosumab is enormous.Denosumab Has Long-Lasting Effects and High Safety
Denosumab as the first fully humanizedRANKLInhibitor, highly effective in inhibitionRANKL/RANK/OPGPathway, with high specificity and high affinity forRANKLCombine, BlockRANKLAnd its receptorRANKCombination, inhibiting the generation and function of osteoclasts, thereby reducing bone resorption, increasing bone mass, improving bone strength, and treating osteoporosis.Unique pharmacokinetic and pharmacodynamic properties support a twice-yearly dosing regimen, which can rapidly suppress bone turnover markers after administration, continuously reduce bone resorption, and is convenient to use with sustained effectiveness. The precise pharmacological mechanism allows denosumab to act on 100% of the skeleton without bone matrix deposition issues, making it suitable for long-term use. Studies have shown that denosumab can be used continuously for over ten years with good safety.China-produced Rukexin Benefits Chinese Osteoporosis Patients
Qilu Pharmaceutical strictly follows the biologics development and management standards. After a decade of research and development, the bioequivalence study shows that Rukexin is bioequivalent to the reference originator drug in terms of pharmacokinetics, pharmacodynamics, immunogenicity, efficacy, and safety.Under the leadership of Professor Zhang Zhenlin from the Sixth People's Hospital affiliated with Shanghai Jiao Tong University, the Phase III clinical trial of Lukexin was conducted as a prospective, multicenter, randomized, double-blind, placebo-controlled study by 31 hospitals across China. The article was published in Acta Pharmacologica Sinica in July 2022, demonstrating that Lukexin has good efficacy and safety for postmenopausal osteoporosis in Chinese women at high risk of fractures. This article is the first large-scale clinical study data published in China on the efficacy and safety of denosumab (Lukexin) in treating Chinese osteoporosis patients, providing data support from the Chinese population for the clinical use of denosumab and other RANKL-targeting drugs in China. It also provides Chinese population data for the first time to update domestic expert consensus guidelines and expand clinical pathways. This study is also the world’s first published clinical research on a denosumab biosimilar, offering evidence-based support for the substitution of domestically produced medications for Chinese patients.Multiple guidelines recommend denosumab as a first-line treatment for osteoporosis.
Denosumab has been unanimously recommended by guidelines both in China and internationally. These include China's "Guidelines for the Diagnosis and Treatment of Primary Osteoporosis," the American Association of Clinical Endocrinologists/American College of Endocrinology (AACE/ACE), the Endocrine Society Annual Meeting (ENDO), the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO), among others, which list denosumab as one of the initial or most commonly used treatment options for osteoporosis.Currently, the denosumab injection has been successfully included in the 2022 National Medical Insurance Catalogue, used for the treatment of severe osteoporosis in postmenopausal women, significantly reducing the financial burden on patients and providing long-term care for bone health.Qilu Pharmaceutical Always Adheres to the Core Values of "Great Doctors with Precision and Sincerity, Family, Country, and the World," Centering on Patients and Ensuring Drug Quality Throughout the Entire Process. With the Launch of Lukexin, Qilu Pharmaceutical Will Continue to Advance in the Fields of Orthopedics and Osteoporosis, Promoting the Availability and Affordability of More High-Quality Chinese Drugs for the Public.
