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This study assessed the efficacy, safety, pharmacokinetics (PK), and immunogenicity profiles of a denosumab biosimilar (LY06006) in Chinese postmenopausal osteoporotic women with a high risk of fracture.In this multicenter, randomized, double-blind, placebo-controlled, phase 3 trial, 448 postmenopausal women aged 50-85 years with osteoporosis were enrolled at 49 centers in China and were randomly assigned (3:1) to receive 60 ​mg of the denosumab biosimilar (LY06006) or placebo subcutaneously every 6 months for 1 year. Lumbar spine bone mineral density (BMD) change was the primary endpoint.Of the 448 randomized patients, 409 (LY06006, n ​= ​311; placebo, n ​= ​98) completed the study. All 448 (100.0%) subjects were included in the intent-to-treat (ITT) trial, 427 (95.3%) were included in the full analysis set (FAS), 408 (91.1%) were included in the per protocol set (PPS), 446 (99.6%) were included in the safety set (SS), and 336 (75.0%) were included in the pharmacokinetics concentration set (PKCs). For the primary endpoint, a 4.71% (95% CI, 3.81%, 5.60%) treatment difference in percent change in lumbar spine BMD from baseline to month 12 was observed in the LY06006 group compared with the placebo group (P ​ ​0.0001). For the secondary endpoints, LY06006 was associated with increased lumbar spine BMD levels measured at month 6, BMD levels at the femoral neck, total hip, and trochanter measured at months 6 and 12 and reduced serum C-terminal telopeptide of type 1 collagen (CTX) and procollagen type 1 ​N-peptide (P1NP) levels at months 1, 6, and 12. Safety analysis was based on the safety analysis set (SS), and 264 (78.6%) subjects in the LY06006 group and 83 (75.5%) in the placebo group experienced adverse events (AEs). Most events were mild or moderate and not related to the study drugs.In postmenopausal women with a high risk of fracture, LY06006 increased the BMD and decreased bone resorption; thus, LY06006 might be an effective treatment for osteoporosis. LY06006 was generally safe and well tolerated without unexpected adverse reactions, similar to the reference drug Prolia®. The characteristics of effectiveness and safety were similar to those reported in previous studies.In this multi-center, randomized, double-blind, placebo-controlled phase 3 study, LY06006 showed substantially efficacy to increase BMD and well tolerance without unexpected adverse reactions, which is comparable to the reference drug Prolia ®. The presented results are encouraging and can offer some valuable evidence for the clinical practice.

Short Message Communication (SMC) is a featured service of BeiDou Navigation Satellite System (BDS). After its successful deployment in 2003, Regional Short Message Communication (RSMC) service has been continuously serving China and its neighboring countries and regions, especially in life safety scenarios. In this paper, the architecture of the Global Short Message Communication (GSMC) system is proposed based on the medium earth orbit (MEO) constellation and the crosslinks of the global BeiDou navigation system (BDS-3). Three subtypes of GSMC service, i.e. positioning report, emergency search and rescue (SAR) and regular SMC are designed in accordance with the technical characteristic of integration of navigation and communication in BDS-3, which supports future wide applications of GSMC. The performance of the designed GSMC system is analyzed by numerical calculations. As BDS-3 was officially announced completion on July 31, 2020, GSMC has been providing initial service. First test results of the in orbit GSMC payloads are also presented in the paper to verify the designed capabilities. Preliminary results also show that the requirements of Global Maritime Distress and Safety System (GMDSS) can also be fulfilled.

CPM (continuous phase modulation) has been widely used in the field of satellite communication, which has high spectrum efficiency and constant envelope. This paper explores the applicability of CPM to satellite navigation. A SS-CPM (Spread-Spectrum CPM) modulation is investigated. The SS-CPM with tuned parameters can resemble the spectrum of Binary Offset Carrier (BOC) modulation and yields comparable performance in terms of tracking accuracy, multipath mitigation, anti-jamming, and compatibility. The BOC-like SS-CPM signal maintains the constant envelope at transmission and less out-band emission in radio determination satellite service (RDSS) band, which provides a reference modulation for COMPASS satellite navigation signal.

ChREBP regulates lipogenesis and glucose utilization in the liver. Current reports suggest a contradictive association between rs3812316 of this gene and triglyceride level. We hypothesized the polymorphisms in ChREBP gene were associated with CAD in Chinese population.The ChREBP gene polymorphisms were analyzed by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) methods in 200 controls and 310 CAD patients. Serum lipids and glucose concentrations were measured in all subjects. Haplotypes were constructed based on rs3812316, rs7798357 and rs1051921. All the data were analyzed using SPSS14.0, PLINK1.07 and SHEsis software.The rare allele G of rs3812316 was significantly lower in the CAD group after adjusting for age, sex, BMI, SBP and DBP (OR(a)=0.589, 95%CI=0.361-0.961, P=0.034). No significant differences between cases and controls were found in genotype or allele distributions of rs7798357, rs17145750 and rs1051921. Haplotype CGC was significant higher in CAD group (P0.01, OR=2.364, 95%CI=1.608-3.474), while haplotypes GGC, CGT, CCC were significant lower in CAD group (P0.05).The rs3812316 and the haplotypes in ChREBP gene appeared to be related to high susceptibility to CAD.