QL Pharma's Novel Denosumab Biosimilar LuKexin (QL1206) Submits IPO Prospectus: A Breakthrough Therapy for Fragility Fracture Prevention in Postmenopausal Osteoporosis

Dec 05, 2023 17:01 CST Updated 17:01

Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

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Qilu Pharmaceutical's Lukexin (Denosumab Injection) took eleven years to develop, and was2023Year9Approved for marketing in [Month], this product can reduce the number and function of osteoclasts by inhibiting their formation, activation, and survival, decrease bone resorption, and increase bone density to treat osteoporosis, significantly reducing the risk of secondary fractures after fragility fractures. The Phase III clinical trial data strongly supports the product's efficacy and safety.

Ruxience (QL1206), a Denosumab Biosimilar

Led by Professor Zhang Zhenlin from the Sixth People's Hospital Affiliated to Shanghai Jiao Tong University, 31 hospitals across China jointly conducted a Phase III clinical trial of Rucosine (QL1206). A one-year prospective, multicenter, randomized, double-blind, placebo-controlled study was carried out. The Phase III clinical trial was successfully completed in July 2021 and in July 2022.Acta Pharmacologica Sinica(Impact Factor: 7.169) Publication: A Phase III Randomized, Double-Blind, Placebo-Controlled Trial of the Denosumab Biosimilar QL1206 in Postmenopausal Chinese Women with Osteoporosis and High Fracture Risk. This study demonstrated that Rukexin (QL1206) has good efficacy and safety in postmenopausal Chinese women with osteoporosis and a high risk of fractures. The clinical trial design was rigorous and professional, and the journal in which it was published has a high impact factor. Furthermore, this article is the first large-scale clinical research data on the efficacy and safety of denosumab for treating osteoporosis in the Chinese population. Its publication fills a gap in China and provides, for the first time, data support from the Chinese population for the clinical use of denosumab and other RANKL-targeting drugs in osteoporosis treatment. It also offers data from the Chinese population for the first time to update expert consensus guidelines and expand clinical pathways in China.

Phase Ⅲ Clinical TrialTestAchievements

Since April 2019From 2021 to July 2021, 455 postmenopausal women with osteoporosis who met the criteria from 31 research centers across China were randomly assigned to the experimental group and the control group in a 3:1 ratio. The drug was administered once every 6 months for a total of 2 doses, and all participants took daily oral supplements of elemental calcium (500 mg) and vitamin D (400 international units). The primary endpoint was the percentage change in lumbar spine BMD at 12 months. Secondary endpoints included the percentage change in lumbar spine BMD at 6 months, as well as the percentage changes in total hip, femoral neck, and trochanteric BMD at 6 and 12 months, along with serum levels of type 1 collagen cross-linked C-telopeptide (CT).X) and type 1 procollagen amino-terminal propeptide (P1NP) levels. During the trial, all adverse events occurring in the subjects during the clinical trial and the immunogenicity incidence in the two groups were observed as safety indicators. Blood samples were collected for the pharmacokinetics (PK) of QL1206 to support population pharmacokinetics and exposure-response (dose-response) analysis.

After 12 months of follow-up, compared with the placebo group, the QL1206 group showed a significant increase in lumbar spine BMD (mean difference and 95% CI): 4.780% (3.880%, 5.681%), total hip: 3.930% (3.136%, 4.725%), femoral neck: 2.733% (1.877%, 3.589%), and trochanter: 4.058% (2.791%, 5.325%). This indicates that the treatment difference between QL1206 and placebo groups was statistically significant at the primary endpoint. For secondary endpoints, QL1206 treatment increased BMD levels at all sites at months 6 and 12 and reduced serum CTX and P1NP levels at months 1, 6, and 12, with statistically significant differences.

QL1206 was well-tolerated within 12 months, with no deaths, atypical femoral fractures (AFF), or osteonecrosis of the jaws (ONJ) events occurring, and no unexpected adverse events were observed.

Lukexin—Precise Targeting, Renewed Bone Life

Studies show that Rucosin (QL1206) can effectively increase bone mineral density in the lumbar spine, total hip, femoral neck, and trochanter of postmenopausal women with osteoporosis in China. It also rapidly reduces bone turnover markers. This demonstrates its good efficacy and safety profile for postmenopausal women with osteoporosis in China who are at high risk of fractures. For patients with fragility fractures, anti-osteoporosis treatment is equally important. Multiple studies have shown that denosumab significantly reduces the risk of subsequent fractures in fracture patients, alleviates back pain-related activity limitations, and improves overall outcomes.Health-Related Quality of Life(HRQoL), without affecting fracture healing in patients, without increasing the risk of healing or surgery-related complications, and has been widely recognized by guidelines both in China and internationally.

Qilu Pharmaceutical's Lukexin (Denosumab Injection) Brings More Treatment Options for Fragility Fracture Patients, Aiding in Faster Recovery!

Introduction to Qilu Pharmaceutical Co., Ltd.

Qilu Pharmaceutical is a large comprehensive modern pharmaceutical enterprise in China, specializing in the research, production, and sales of formulations and active pharmaceutical ingredients for the treatment of cancer, cardiovascular and cerebrovascular diseases, anti-infection, psychiatric disorders, neurological disorders, and ophthalmic diseases. Qilu Pharmaceutical always adheres to the core corporate values of "Great Medicine with Sincerity, Family and Country under Heaven," focusing on patients and ensuring drug quality throughout all processes. With the introduction of Lukexin...®The listing of Qilu Pharmaceutical will continue to promote the availability and affordability of more high-quality domestically produced drugs in the field of orthopedics and osteoporosis.

This articleThis article only represents the author's personal views, not the official position of Gujin Zhongwai. It is hoped that everyone will make rational judgments and apply them in a targeted manner.

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