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On January 31, Colum Pharmaceuticals announced that it had recently obtained the approval of the State Drug Administration to issue the "Drug Supplemental Application Approval Notice" for the chemical "Sodium fluconazole chloride injection", which is evaluated by the quality and efficacy of generic drugs.
fluoroconazole is a whole-body antifellar drug, with a broad antibacterial spectrum, small liver and kidney toxicity, the advantages of wide tissue distribution, primary prevention of invasive fungal infections and candititis infection treatment of the first-line drugs, currently widely used in clinical respiratory, infectious, ICU and hematology, etc., has been "Chinese adult candide" The consensus of experts in diagnosis and treatment of bacterial diseases (2020), the diagnostic standards and treatment principles for invasive fungal diseases in patients with blood diseases/malignant tumors (2020), and the technical specifications for clinical diagnosis and treatment of invasive fungal diseases in organ transplant recipients (2019 edition) are recommended.
fluoroconazole domestic market a variety of dosage forms, of which injections are the preferred dosage form for invasive Candide infection.
sodium fluorconazole injections are the national health insurance catalogue varieties in 2020 and the national base drug catalogue varieties in 2018, and the sales of fluoroconazole infusions in Public Hospitals in China in 2019 are 1.11 billion yuan.
at the same time, also issued a notice of approval, the company recently obtained the Approval Notice of the Chemical Drug "Fat Milk (10%)/Amino Acids (15)/Glucose (20%) Injection" approved by the State Drug Administration, which is evaluated by the quality and efficacy of generic drugs.
this product is mainly used for nutritional supplementation for children over 2 years of age and adult patients who are not fully functional or who are unable to get nutrition through the mouth/intestinal tract.
intestinal nutrition plays an important role in the treatment of patients with critical injury and severe trauma, which can quickly provide the nutrients needed by the body, promote the recovery of patients and improve the prognostics of the disease.
At present, our company has been approved to market 10 new intestinal nutrition products, covering single bags, double-room bags, three-cavity bag packaging form, differentiated product formulations to meet different types (liver function impairment, peri-surgical period, critical illness, etc.) and different energy needs of patients nutritional treatment.
clinically reasonable extraintestinal nutrition requires simultaneous input of fatty milk, amino acids, glucose, etc., but these nutrients must be individually packaged to achieve a stable existence.
three cavity bags will be fat milk, amino acids and glucose in three separate chambers, to ensure the stability of the pre-mixing chamber fluid.
open, mixed and ready-to-use when used clinically, the preparation can be completed in seconds, the clinical application is convenient, and can effectively avoid the risk of pollution in the preparation process.
Three cavity bag for Colum has the advantages of independent intellectual property rights technology platform, the inner package material using the international mainstream green polypropylene material, by the surrounding thermal pressure welding and isolation strip weak welding made, mixing the first 3 chambers independent, and strong anti-flush pressure, to ensure the stability of the independent chamber fluid in the transport and storage process.
completely separate dual hose design is used to add fluids according to the patient's condition during the infusion process by using a completely separate dual hose design.
the current company's platform has 4 products listed, a number of varieties in the study.
Fat Milk (10%)/Amino Acids (15)/Glucose (20%) injections are the world's first approved three-cavity bag series, with a reasonable sugar-fat ratio and hot nitrogen ratio, flexible dosing pathways (outer and central intravenous), to better meet the needs of complementary extraintestinal nutrition, and for both children and adult patients.
2019, China's public hospital sales of 130 million yuan.