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First-time consistency evaluation of domestic alfacalcidol remodeling osteoporosis drug market
Recently, the State Drug Administration (hereinafter referred to as the “National Bureauâ€) issued the “Approval of Pharmaceutical Supplements†for the two specifications of Alfacalcitol tablets 0.25μg and 0.5μg (the approval number is 2018B02983 and 2018B02977), which indicates that Chongqing Yaoyou Pharmaceutical Co., Ltd. (hereinafter referred to as “Pharmaceutical Pharmaceuticalsâ€) successfully passed the evaluation of the quality and efficacy of generic drugs, and is the first in China for the oral solid preparation of Alfacalcitol. And the only variety that passed the consistency evaluation.
Status of conformity assessment
Pharmacological Pharmaceuticals Alfa Calcium Hydrochloride Tablets, trade name “Liqing®â€, was first listed in China in 1995, and currently only the pharmaceutical company is a tablet. In September 2017, Yaoyou Pharmaceutical first filed an application with the National Bureau and was accepted. In November 2017, Yaoyou Pharmaceutical accepted the first batch of consistency evaluation of the National Bureau for on-site verification and successfully passed.
At present, only the Luogaoquan® (calciferol injection) in the Alfacalcitol preparation and calcitriol preparations in the China Listed Pharmaceuticals Catalogue, except for Yaoyou Pharmaceutical, has no other Alpha ossification. alcohol formulation and preparation of calcitriol production enterprises to declare conformity evaluation.
Epidemiology and market overview
Liqing® is mainly used for osteoporosis and for improving chronic renal insufficiency, hypoparathyroidism, anti-vitamin D rickets, osteomalacia patients with abnormal symptoms of vitamin D metabolism (such as hypocalcemia, paralysis, bone pain) And bone damage).
In recent years, the number of patients with osteoporosis in China has gradually increased. According to the "China Osteoporosis White Paper" published by the International Osteoporosis Foundation, at least 69.44 million people in China suffer from osteoporosis, and another 210 million people have lower bone mass than normal. In addition, there is a clear “younger†trend in patients with osteoporosis. According to the International Osteoporosis Foundation, by 2020, there will be 286 million people with low bone mineral density or osteoporosis in China. .
According to the occurrence of the disease , anti-osteoporosis drugs mainly have basic supplements, inhibition of bone resorption drugs and bone-promoting drugs. The basic drugs for drug treatment mainly include calcium and vitamin D. Clinically, inhibition of bone resorption by osteoclasts is the main treatment. The main drugs are bisphosphonates, estrogen and its receptor modulators, and calcitonin. Parathyroid hormone is an osteogenic drug. Bismuth salts and vitamin K2 have anti-bone absorption and bone formation.
According to PDB data in 2017, the total market size of osteoporosis drugs is over 20 billion yuan, an increase of about 11.0% year-on-year. Among them, calcium accounts for half of the country, and vitamin D preparations account for 33.6% of the market.
Among the TOP10 varieties in the osteoporosis calcium supplement market, Alfacalcitol ranked seventh. Alfacalcidol has also been used in community hospitals , achieving full coverage of primary hospitals and city-level hospitals. The PDB sample hospital medication showed that Alfacalcitol and calcitriol market exceeded 700 million yuan.
According to the PDB data in the first quarter of 2018, Liqing® has a market share of more than 7% in the Alfacalcitol market, which is increasing rapidly year by year. With the adoption of the consistency evaluation, its market share will accelerate and expand, with broad prospects.
Authoritative recommendation, trust choice
A number of guideline consensus and clinical pathways recommend Alfacalcitol for various types of osteoporosis (senile/postmenopausal/glucocorticoid osteoporosis, etc.), hypoparathyroidism, and secondary parathyroid glands A therapeutic drug that is hyperactive.
Guideline Consensus: Guidelines for the Diagnosis and Treatment of Primary Osteoporosis (2017 Edition), Expert Consensus on the Diagnosis and Treatment of Osteoporosis Induced by Glucocorticoids (2013 Edition), and Handbook for Prevention and Treatment of Osteoporosis in China (2013 Edition) ), "Guidelines for the diagnosis and treatment of hypoparathyroidism and pseudohypoparathyroidism (2006 edition, discussion paper)", "Expert consensus on the rational application of active vitamin D in secondary hyperparathyroidism of chronic kidney disease" (2005 Edition)
Clinical Pathway: Clinical Pathway of Rheumatoid Arthritis with Pulmonary Interstitial Fibrosis, Clinical Pathway of Sjogren's Syndrome with Pulmonary Interstitial Fibrosis, Clinical Pathway of Sjogren's Syndrome, Clinical Pathway of Adult Still Disease, White Clinical Pathology of Saychel's Disease (Behcet's Disease), "Clinical Pathway of Granulomatous Polyangiitis", "Clinical Pathway of Microscopic Polyangiitis (MPA)"
Challenges and opportunities
At present, according to the monitoring of the China New Drug Development Monitoring Database (CPM), a total of 8 manufacturing companies are conducting a conformity evaluation of Alfacalcidol. The main dosage forms include tablets, capsules and soft capsules. Among them, the tablet market only had one application from Chongqing Pharmaceutical Pharmaceutical Co., Ltd. and passed the consistency evaluation. Other companies are mainly pushing the soft capsule market. Through the market segmentation strategy, Chongqing Pharmaceuticals avoided excessive homogenous competition.
The consistency evaluation of generic drugs is a challenge and an opportunity! Appropriate support for medical insurance through the consistency of the evaluation of the drug variety, medical institutions should be preferred to purchase and preferred in the clinical. The pharmaceutical company Afa Calcium Carbonate successfully passed the consistency evaluation, which is conducive to improving product competitiveness, consolidating and enhancing the market position of varieties and bringing new market opportunities.