Enoxaparin sodium of Shuanglu Pharmaceutical Co., Ltd. is expected to obtain production approval in June

According to the information of the State Food and Drug Administration (CFDA), enoxaparin sodium and its preparations declared by Shuanglu Pharmaceutical (002038 SZ) have entered the stage of waiting for on-site inspection, which means that the drug has passed the new drug technical review, waiting for on-site inspection, forming the review conclusion, reporting to the drug review center, submitting to the Drug Administration for signature and other procedures, which is expected to be obtained in six months Production approval Enoxaparin sodium is a kind of low molecular weight heparin, which is used to prevent and treat deep vein thrombosis or pulmonary embolism Suzhou Erye Pharmaceutical Co., Ltd and Shenzhen Tiandao Pharmaceutical Co., Ltd have already produced the product in China, and Qianhong Pharmaceutical Co., Ltd (002550 SZ) is the listed company in the evaluation stage It is worth mentioning that Qianhong pharmaceutical has arranged its production and marketing plan, "everything is ready but without approval" Insiders of Shuanglu pharmaceutical industry said that it was not convenient to disclose the specific promotion plan before the official approval was obtained Shuanglu pharmaceutical industry is mainly engaged in the research, development, production and operation of genetic engineering drugs, biochemical drugs, chemical raw materials, preparations and antibiotic products In the third quarter report of 2014, the company estimated that the net profit attributable to shareholders of the listed company for the whole year was 6928769 to 808356400 yuan, up 20% to 40% year on year Overview of enoxaparin sodium: enoxaparin sodium is a new antithrombotic drug developed by Aventis company of France It was approved by FDA in October 2004 The product ranked 28th among the top 100 best selling drugs in the world in 2003, with global sales of US $1877 million Its main indications are: prevention of deep vein thrombosis and pulmonary embolism; treatment of formed vein thrombosis; prevention of thrombosis during cardiopulmonary bypass during hemodialysis; treatment of unstable angina pectoris and non-Q wave myocardial infarction Enoxaparin sodium injection has been approved to be imported in China, but the API has not been imported into China and has not been approved for production by enterprises Therefore, the preparation belongs to 6 categories, and the API belongs to 3.1 categories [indications] prevention of deep vein thrombosis and pulmonary embolism; treatment of formed vein thrombosis; prevention of thrombosis during cardiopulmonary bypass during hemodialysis; treatment of unstable angina and non-Q wave myocardial infarction [dosage and usage] to prevent deep vein thrombosis, 40 mg was given to adults with high risk of thrombosis 12 hours before operation, and then 40 mg was injected subcutaneously every 24 hours Patients with moderate risk of thrombus were given 20mg 2 hours before operation, and then subcutaneously injected every 24 hours The above treatment should last for 10-14 days or until the risk of thrombus disappears The weight of venous thrombus was 1 mg / kg and subcutaneously administered every 12 hr for 10 days A single dose of 1 mg / kg body weight was given before cpd The above dosage is enough for 4 hr dialysis course (unless fibrin ring is formed) If the dialysis time needs to be extended, a quarter of the above dosage shall be added every hour Within 24 hours after the onset of unstable angina and non-Q wave myocardial infarction, 1 mg / kg body weight was administered subcutaneously every 12 hours for 6-8 days until the clinical symptoms were stable [Specification]: injection 20 mg, 40 mg, 60 mg, 80 mg, 100 mg