"Drug Curry Jun" Qilu, Howson first imitation pile listed! $3 billion variety into the new player; pancreatic cancer liposome drug application on the market; Heng Rui, shi medicine Oyi, Xinlitai...

Read: The Latest! Drug review dynamics!this week:the first copy of the new drug "Mesosula resagilan" for Ziru Parkinson's disease is about to be approved2 heavy-duty central nervous system disease drugs on the marketa long-lasting EPO in Chinaapplication for the treatment of pancreatic cancer Ilitikang lipid was acceptedcurrent issue (June 19-28) international and domestic drug approvals are proceeding in an orderly mannerDomestic drugs in the international opening of acceleration mode, Baiji Shenzhou Zebtini listing application by the European EMA processing, and huang medicine furorequinini obtained the FDA fast-track qualification, Hengrui hydrochloric acid right metomidine sodium chloride injection by the United States FDA application for a simplified new drug (ANDA)There is also good news in India: Favilawe and Redsiwe have all been given new titles in Indiain China, involving breast cancer, lung cancer, esophageal scale cancer and other fields of 2 PD-1, 2 heavy biological similar drugs, 2 clinically urgently needed large varieties and other heavy products, have been issued (detailed dynamic click on the last period of medicine Curry: "Drug Curry" 2 global TOP10 best-selling drug "dangerous"; Swiss class 1 new drug .., the current issue of more dynamics as follows:domestic review and approval of new dynamicsthis week CDE has 62 acceptance numbers (43 varieties) reported production status updates, of which 50 status updates "issued", 12 status updates "in approval", the specific dynamics are as follows:focus on the current issue: Paliquinone release tablets, methyl sulfonate saquilla tablets and dajstine.co.uk's Haussen-Paliquinone slow release tablet, Onitrogen flat-mouth collapse tablets approved for the market2019, Howson's central nervous system disease drug portfolio revenue of about 2.171 billion yuan, accounting for 25% of its total revenueThe approval of two drugs for central nervous disease (paliquinone and onitrogle flat- collapse) in Haussen further improved the products of central nervous system diseasesAmong them, paliquinone slow release tablets for the first imitation in ChinaPaliquinone, a second-generation antipsychotic drug developed by Johnson and Johnson, was approved by the FDA for listing in December 2006Entered China in 2008, currently approved two indications: the treatment of adult schizophrenia and the treatment of adolescents (12-17 years old, weight of 29 kg) schizophreniaGlobal sales reached $3.33 billion in 2019This Haussen as the first imitation approved, stone drug Europai's Paliquinone slow release tablets are also listed in imitation 4 categories of declaration, is currently in the review and approvalAo nitrogen flat sheet for the 4 plus 7 band procurement varieties, the domestic market share is mainly occupied by Haussen first imitation, this Hausen O nitrogen flat collapse film has been approved for listing, O Nitrogen ping oral instant membrane, is also in the "review" stageConcord fermentation Kirin-Dayapotin alpha was approved for listing
Dayapotin alpha is a long-acting recombinant human erythropoietin (rhEPO) in AmpinHara Research, which was approved by the FDA in September 2001 for the treatment of renal anemiaThe launch quickly became a bombshell, with sales peaking at $4.12 billion in 2006Prior to this, Roche's long-lasting EPO-methyleneglycol recombinant human erythropoietin has been launched in China, this time for China's second approved listing of the second long-lasting EPOin addition, according to pharmaceutical data, dayoperinalpha registered a total of 3 clinical trials in China, of which Concord fermentation Kirin registered two clinical trials of the indications is renal anemiaAmgen registered clinical trial indications is anaemia caused by first-line chemotherapy for advanced non-small cell lung cancer, which is currently not reported for deliveryZiru-Mfosulu Resagilan tablets, which are about to be approved, are a second-generation monoamine oxidation-B (MAO-B) inhibitor developed by Lundbeck of Denmark and TevaIt was approved by the European Union in February 2005, approved by the FDA for listing in the United States in May 2006, and approved for listing in June 2017At present, the drug has been listed in more than 50 countries and regions around the world, becoming the largest number of prescriptions for Parkinson's disease in many countries In August 2019, the MFOS Resagilan tablet (Anzilai) was first included in the national medical insurance drug regular catalogue, which was introduced on January 1, 2020 Parkinson's disease is the second most common neurodegenerative disease after Alzheimer's disease Data show that China's Parkinson's disease patients about 3.1 million, with the aging problem is becoming more serious, it is expected that by 2030, the global Parkinson's disease will be as high as 9 million, and China will account for about 5 million people, the market potential is huge According to the drug and registration acceptance database shows that, at present, the drug only Qilu and Changzhou four drugs two according to the four categories of declaration, Qilu day will take the first imitation the new acceptance of the domestic review and approval this week CDE added the production acceptance number 21 (18 varieties), of which Shiweia's Ilitikang lipid injection application was accepted; Schvia's Iliticon lipid injection was approved in Japan in June this year for use in Japan in combination with fluorolysine and folate to treat patients with advanced pancreatic cancer (second-line therapy) who have been treated with poor chemotherapy in Gixitabin the domestic layout of Yiliitikang liposome injection liquid generic drugs are: Jiangsu Hengrui, stone drug Ouyi, green leaf pharmaceutical, Colleen Pharmaceuticals, and the current green leaf pharmaceutical small cell lung cancer patients in the efficacy and safety of the IIa clinical research is in progress, this single-arm domestic trial to recruit 30-90 people A randomized, double-blind, parallel control, multicenter phase 3 clinical trial of The Iliticon Lico lipid sinin combination of Hengrui's hydrochloric acid and second-line treatment of locally advanced or metastatic pancreatic cancer is under way Baiji Shenzhou - The fourth application for the listing of the fourth indication of the drug of the Tetrajuzumab was accepted
this issue of CDE accepted its anti-PD-1 antibody drug Baczean (Direlizhu sema-injection) combined chemotherapy to treat patients with advanced non-scale non-small cell lung cancer (NSCLC) new indications listing application (sNDA) Lung cancer is a major cancer in China, this is the second application submitted in China for the first-line advanced NSCLC new indications In April, CDE received a new indicationapplication (sNDA) application for the treatment of patients with first-line advanced squamous non-small cell lung cancer (NSCLC) in combination with two chemotherapy regimens for reliever supret singular injections In addition, three Phase 3 clinical trials of pedion for lung cancer are under way PD-1/L enterprise indications competition has been white heat, who first take the big cancer type of indications, who will master the market opportunity In addition, the drug has been approved in China for Hodgkin's lymphoma and urethra skin cancer data sources: drug intelligence data, enterprise announcements and other network public data source of information: drug intelligence network, enterprise announcements and other network public information .