[drug Kajun] Sanofi's new rare disease drug is on the market in China; Hengrui's first class 1 innovative anesthetic is coming; proton pump inhibitor is facing new competitors

Highlights: 1 New drug for rare diseases - aga β for injection is on the market in China! 2 Hengrui's first innovative anesthetic, rimazolom, will be approved soon! 3 Vonolazan fumarate, a new proton pump inhibitor product, has been approved for market in China! 4 The heavy bomb of pulmonary fibrosis - nedanib breaks through again! New trends of nmpa examination and approval this week 77 reports to production acceptance No (48 varieties) for review and approval status update, good news continues: "Jisi generation" has been approved successfully; Novartis heavy anti-cancer combination dalafeni + trimetinib, Takeda's new mechanism acid suppressor drug Walker have been approved to enter China; Sanofi's rare disease treatment drug for injection of agarase β has also been approved for listing, etc More details are as follows: on December 19, agatase β for injection was approved by the State Food and Drug Administration for the treatment of Fabry's disease, a rare genetic disease It is the first drug approved in China for the treatment of FBR, which is suitable for children and adolescents over 8 years old and adults Agatase β was developed by Genzyme, a subsidiary of Sanofi, and its listing application was undertaken on October 18, 2018, and then included in the priority review It was included in the list of the second batch of clinically urgent overseas new drugs on May 29, 2019 It took 14 months from listing to approval Fabry's disease is a congenital metabolic disease caused by X-linked gene defects In 2018, the disease was included in the first batch of national rare diseases catalogue, which is a serious life-threatening disease and there is no effective treatment in China Source of annual sales data of agatase β: the approval and marketing of this product has brought good news for the treatment of domestic patients with Fabry disease, expecting to have a price close to the people, so that more patients can benefit Ramazolam toluenesulfonate for injection belongs to benzodiazepine, which is a short acting GABAA receptor agonist, suitable for intravenous general anesthesia in selective surgery It has the characteristics of rapid onset and failure, stable sedation and short recovery time It combines the safety of midazolam with the effectiveness of propofol, and is expected to become a "better" drug in intravenous anesthesia, a large variety of clinically necessary According to the pharmaceutical intelligence database, at present, in addition to Hengrui pharmaceutical, the class 1 new drug rimazolum benzenesulfonate developed by humanwell Pharmaceutical Co., Ltd has submitted an application for listing in November 2018 and has been included in the priority review According to the record of clinical trials, rimazolum toluenesulfonate has completed the phase III clinical trial of gastroscopy diagnosis and treatment of sedation and phase III clinical trial of general anesthesia Due to the aging population and the improvement of people's health awareness, the volume of endoscopy in China is increasing year by year, the volume of in-hospital surgery is increasing, and driven by new domestic varieties, the growth rate of intravenous anesthesia market in China is bound to accelerate in the future It is predicted that ramazolam will be the new profit growth point of Hengrui anesthesia line after listing Vonolazan fumarate tablets Vonolazan fumarate is a potassium competitive acid blocker (p-cab) developed by Takeda, which was launched in Japan in February 2015 It is used to treat acid related diseases, including reflux esophagitis, gastric ulcer, duodenal ulcer, preventing recurrence and seclusion of gastric ulcer or duodenal ulcer during the treatment with low dose aspirin or non steroidal anti-inflammatory drugs Eradication of Spirillum In March 2018, the drug review center of the State Drug Administration officially accepted the listing application of Walker ® (vonolazan fumarate) and officially approved the listing on December 18, 2019 The enthusiasm for domestic registration of vonolazan is high According to the data of pharmaceutical intelligence, there are 17 domestic enterprises that have been approved for clinical application, and one enterprise is in clinical trials Review and approval of new acceptance: this week, CDE added 40 production acceptance numbers (25 varieties), including 4 new drugs, 4 imported drugs, 17 generic drugs, details as follows: nedanib ethylsulfonate soft capsule This week, the State Drug Administration officially accepted the registration application of nedanib soft capsule (Viagra) for the treatment of indications of progressive fibrosis interstitial lung disease (pf-ild) This is the second breakthrough in the same year after its application for the treatment of systemic sclerosis related interstitial lung disease (SSC ILD) indications was submitted in China in June this year Nidanib, an anti fibrosis drug, has been approved in 2017 for the treatment of IPF in China In the two years since its launch, nidanib has brought hope for the survival of patients with idiopathic pulmonary fibrosis (IPF) in China This year, two of its new indications have been submitted for listing in China, and they have been submitted simultaneously with Europe and the United States, which means that China is realizing the vision of global simultaneous R & D and listing Data source of listing time of nedanib mesylate in the United States and Europe: drug intelligence data current registration and application in China data source: drug intelligence data, enterprise announcement and other online public data information sources: drug intelligence network, enterprise announcement and other online public information sources With high integration, in-depth analysis and intelligent intelligence of pharmaceutical intelligence data, the intelligent tool platform for pharmaceutical data has been specially built for VIP enterprise customers, covering core data such as drug registration, hospital sales, drug reports, enterprise reports, clinical trials, drug listing, drug bid winning, device listing, drug sales, etc., and providing all-round access to enterprise users from production, research and development, sales, and use And other information channels in various links to help enterprises in R & D and 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