New developments in drug launches in Europe and the United States Fosun, Changzhou, Ambition...

Highlights of the report: in October, eight drugs of domestic pharmaceutical enterprises were approved by the FDA to go on the market; in October, three orphan drugs were approved by the FDA; in October, 34 human drugs were approved to go on the market by the European Union HMA; in the United States, the FDA drugs of domestic pharmaceutical enterprises were approved to go on the market by the FDA In October, there were 8 drugs approved by the FDA (food and Drug Administration of the United States) for listing by domestic pharmaceutical enterprises (2 are temporarily approved by the FDA, as shown in the application No of the winning bid red) See the table below for details, with a month on month increase of 33%, among which 2 are temporarily approved by Fosun Pharmaceutical According to the notice on the official website: This report lists the original and supplementary approvals of NDAs, andas and Blas * within the specified month, including provisional and original approvals, which may be carried out after the selected month As a result, there may be a difference in the number of queries through the database later Figure 1: distribution of FDA approved drug companies in October Dexamethasone, like other glucocorticoids, has anti-inflammatory, anti endotoxin, immunosuppressive, anti shock and stress enhancing pharmacological effects, so it is widely used in various departments to treat various diseases, such as autoimmune diseases, allergies, inflammation, asthma, dermatology and ophthalmology Dexamethasone sodium phosphate injection is an indispensable first-aid drug for rescuing critically ill patients In the past decade, clinicians have used dexamethasone sodium phosphate to treat and prevent drug allergy caused by various Chinese and Western medicines and fever caused by viral cold, which has increased the clinical dosage of dexamethasone year by year So far, China has become the largest dexamethasone market in the world Scenesse (afamelanotide acetate) scenesses is a synthetic peptide and alpha melanocyte stimulating hormone analogue used in the United States to prevent people suffering from erythroprotoporphyria since October 2019 from sun skin injury Scenesses was administered as a subcutaneous implant for two months Overview of EU drug market in October, 34 kinds of drugs were approved by HMA, which are mainly distributed in colon cancer, gastric cancer, allergic rhinitis, urticaria, weight-loss drugs and insulin secretion promoting agents See the table below for details Note: This report only lists part of the contents There is one drug in this batch of listed drugs It is noteworthy that orlistat is a drug used to treat obesity Its main function is to prevent the absorption of fat in human diet by acting as lipase inhibitor, so as to reduce the intake of calories It is intended to be used together with the low calorie diet directed by the health care provider Orlistat is a saturated derivative of lipstatin, an effective natural inhibitor of pancreatic lipase from isolated bacteria (Streptomyces) Therefore, because of its relative simplicity and stability, orlistat was selected as an anti obesity drug rather than lipostatin Summary data from clinical trials showed that, in addition to lifestyle changes such as diet and exercise, people taking orlistat lost about 2-3 kg (4.4-6.6 lb) compared to those who did not take the drug in a year Orlistat can also moderately reduce blood pressure and prevent the onset of type 2 diabetes, whether it is weight loss or other effects It can reduce the incidence of type II diabetes in obese people with the same lifestyle changes FDA's tentative approval: tentative approval refers to that the quality, safety and effectiveness of the drug have met the standards for listing in the United States after examination, but it can't be sold in the United States temporarily due to patent or exclusive rights Data source: drug intelligence data EU (US) drug listing database, FDA / EMA / HMA portal