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On December 16th China's State Drug Administration announced that the new drug, ED-71, owned by Roche's Chugai Pharmaceutical Co., Ltd., had been officially approved for listing in China.
, an active vitamin D3 derivative for the treatment of osteoporosis, was first listed in Japan in 2011, according to public information released last week.
screenshot Source: NMPA Osteoporosis (osteoporosis) is a systemic bone disease that is prone to fractures due to a variety of causes of bone density and bone quality decline, bone microstructage damage, resulting in increased bone brittleness.
, one-third of women and one-fifth of men worldwide are at risk of osteoporosis fractures.
currently, taking active vitamin D is a common drug intervention to improve osteoporosis patients, such as osteosterols, α-osteosterols.
drugs are also more suitable for the elderly, renal insperifuration, 1 alpha hydroxyenase deficiency.
a derivative of active vitamin D3.
tests have shown that the product is used on human bone-breaking prescellular cells and inhibits the formation of bone-breaking cells.
other animal tests have also shown that Edi osteoalinol can promote the absorption of calcium in the small intestine, increase the concentration of blood calcium.
also improve bone metabolism and calcium absorption, improve bone density and bone strength, and thus reduce the occurrence of osteoporosis fractures.
March 2018, the application for the listing of a new drug in China for Edi bone alcohol softgels was accepted by CDE.
, according to an earlier press release issued by Sino-Japanese Pharmaceutical Co., Ltd., the application is based on the positive results of three key studies it conducted in China.
This is a randomized, double-blind, parallel controlled trial that compares the efficacy and safety of Edi osteoporosis and afa osteoporosis in patients with primary osteoporosis.
study focused on the rate of change of lumbar vertebral density (L1-4 BMD) relative to baseline value after 12 months, and the time distribution of the change rate of lumbar vertebral density relative to baseline value.
results showed a statistically significant increase in BMD in patients who received added osteosterol compared to those in the control group.
security aspects are consistent with previous reports.
the study showed that Adi osteoporosis in the treatment of primary osteoporosis, the efficacy is better than alfa osteotisol, can significantly increase the density of bone minerals in patients, and the safety is similar to aphalphthalol.
, osteoporosis has become an important health problem for people over the age of 50.
, osteoporosis is particularly serious in middle-aged and elderly women.
osteoporosis is aimed at preventing fractures and disorders of motor organs associated with fractures and organ dysfunction.
, especially in severe cases, bedridden is a treatment priority for maintaining and improving the quality of life of patients.
, there is an urgent need for drugs to increase bone density and reduce the risk of fractures.
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